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Background: There is a need to standardize monitoring in obstetric research of twin pregnancies. Identification of birth weight discordance (BWD), defined as a difference in the birth weights of twins, is a well-documented phenomenon in twin pregnancies. Ultrasound for the diagnosis of BWD informs complex decision making including whether to intervene medically (via laser photo coagulation) or deliver the twins to avoid fetal morbidities or even death. The question is, how accurate is this measurement?, Objectives: To determine the diagnostic accuracy (sensitivity and specificity) of ultrasound estimated fetal weight discordance (EFWD) of 20% and 25% using different estimated biometric ultrasound measurements compared with the actual BWD as the reference standard in twin pregnancies., Search Methods: The search for this review was performed on 15 March 2019. We searched CENTRAL, MEDLINE (Ovid), Embase (Ovid), seven other databases, conference proceedings, reference lists and contacted experts. There were no language or date restrictions applied to the electronic searches, and no methodological filters to maximize sensitivity., Selection Criteria: We selected cohort-type studies with delayed verification that evaluated the accuracy of biometric measurements at ultrasound scanning of twin pregnancies that had been proposed for the diagnosis of estimated BWD, compared to BWD measurements after birth as a reference standard. In addition, we only selected studies that considered twin pregnancies and applied a reference standard for EFWD for the target condition of BWD., Data Collection and Analysis: We screened all titles generated by electronic database searches. Two review authors independently assessed the abstracts of all potentially relevant studies. We assessed the identified full papers for eligibility, and extracted data to create 2 × 2 tables. Two review authors independently performed quality assessment using the QUADAS-2 tool. We excluded studies that did not report data in sufficient detail to construct 2 × 2 tables, and where this information was not available from the primary investigators. We assessed the certainty of the evidence using the GRADE approach., Main Results: We included 39 eligible studies with a median study sample size of 140. In terms of risk of bias, there were many unclear statements regarding patient selection, index test and use of proper reference standard. Twenty-one studies (53%) were of methodological concern due to flow and timing. In terms of applicability, most studies were of low concern. Ultrasound for diagnosis of BWD in twin pregnancies at 20% cut-off Twenty-two studies provided data for a BWD of 20% and the summary estimate of sensitivity was 0.51 (95% CI 0.42 to 0.60), and the summary estimate of specificity was 0.91 (95% CI 0.89 to 0.93) (8005 twin pregnancies; very low-certainty evidence). Ultrasound for diagnosis of BWD in twin pregnancies at 25% cut-off Eighteen studies provided data using a BWD discordance of 25%. The summary estimate of sensitivity was 0.46 (95% CI 0.26 to 0.66), and the summary estimate of specificity was 0.93 (95% CI 0.89 to 0.96) (6471 twin pregnancies; very low-certainty evidence). Subgroup analyses were possible for both BWD of 20% and 25%. The diagnostic accuracy did not differ substantially between estimation by abdominal circumference and femur length but femur length had a trend towards higher sensitivity and specificity. Subgroup analyses were not possible by sex of twins, chorionicity or gestational age due to insufficient data., Authors' Conclusions: Very low-certainty evidence suggests that EFWD identified by ultrasound has low sensitivity but good specificity in detecting BWD in twin pregnancies. There is uncertain diagnostic value of EFWD; this review suggests there is insufficient evidence to support this index as the sole measure for clinical decision making to evaluate the prognosis of twins with growth discordance. The diagnostic accuracy of other measures including amniotic fluid index and umbilical artery Doppler resistive indices in combination with ultrasound for clinical intervention requires evaluation. Future well-designed studies could also evaluate the impact of chorionicity, sex and gestational age in the diagnostic accuracy of ultrasound for EFWD., (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: Dementia is a common and serious neuropsychiatric syndrome, characterised by progressive cognitive and functional decline. The majority of people with dementia develop behavioural disturbances, also known as behavioural and psychological symptoms of dementia (BPSD). Several non-pharmacological interventions have been evaluated to treat BPSD in people with dementia. Simulated presence therapy (SPT), an intervention that uses video or audiotape recordings of family members played to the person with dementia, is a possible approach to treat BPSD., Objectives: To assess the effects of SPT on behavioural and psychological symptoms and quality of life in people with dementia., Search Methods: We searched ALOIS (the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group), CENTRAL (The Cochrane Library) (9 April 2020), MEDLINE Ovid SP (1946 to 9 April 2020), Embase Ovid SP (1972 to 9 April 2020), PsycINFO Ovid SP (1806 to 9 April 2020), CINAHL via EBSCOhost (1980 to 9 April 2020), LILACS via BIREME (all dates to 9 April 2020), ClinicalTrials.gov (ClinicalTrials.gov) (all dates to 9 April 2020), and the World Health Organization (WHO) Portal (apps.who.int/trialsearch) (all dates to 9 April 2020). We also checked the reference lists of relevant articles to identify any additional studies., Selection Criteria: Randomised and quasi-randomised controlled trials, including cross-over studies, that evaluated the efficacy of SPT, consisting of personalised audio or videotape recordings of family members, in people with any form of dementia., Data Collection and Analysis: Two authors independently selected studies, assessed risk of bias and extracted data. No meta-analyses were conducted because of substantial heterogeneity among the included studies., Main Results: Three trials with 144 participants met the inclusion criteria. Two of the trials had a randomised cross-over design, one was a cross-over trial which we classified as quasi-randomised. Participants in the included studies were people with dementia living in nursing homes. They were predominantly women and had a mean age of over 80 years. SPT was performed using an audio or video recording prepared by family members or surrogates. It varied in its content, frequency of administration and duration. All the studies compared multiple treatments. In one study, SPT was compared with two other interventions; in the other two studies, it was compared with three other interventions. Specifically, SPT was compared to usual care, personalised music (two studies), a 'placebo' audiotape containing the voice of a person (two studies), and one-to-one social interaction performed by trained research assistants (one study). In terms of outcomes evaluated, one study considered agitation and withdrawn behaviour (both assessed with three methods); the second study evaluated verbal disruptive behaviour (assessed with three methods); and the third study evaluated physically agitated behaviour and verbally agitated behaviour (the method used was not clearly described). According to the GRADE criteria, the overall quality of the evidence was very low due to very small numbers of participants and risk of bias in the included studies; (none of the trials was at low risk of selection bias; all the trials were at high risk of performance bias; one trial was at high risk of attrition bias; and all had unclear selective reporting). Because of variation in the participants, the format of SPT, the comparison interventions, and the measures used to assess outcomes, we judged the results unsuitable for a meta-analysis. Within each trial, the effect of SPT on behaviour, compared to usual care, was mixed and depended on the measure used. Two trials which included a personalised music intervention reported no significant differences between simulated presence and music on behavioural outcomes. Because the overall quality of the evidence was very low, we were very uncertain regarding all the results None of the studies evaluated quality of life or any of our secondary outcome measures (performance of activities of daily living, dropout and carer burden)., Authors' Conclusions: We were unable to draw any conclusions about the efficacy of SPT for treating behavioural and psychological symptoms and improving quality of life of people with dementia. New high-quality studies are needed to investigate the effect of SPT., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: Injuries to the recurrent inferior laryngeal nerve (RILN) remain one of the major post-operative complications after thyroid and parathyroid surgery. Damage to this nerve can result in a temporary or permanent palsy, which is associated with vocal cord paresis or paralysis. Visual identification of the RILN is a common procedure to prevent nerve injury during thyroid and parathyroid surgery. Recently, intraoperative neuromonitoring (IONM) has been introduced in order to facilitate the localisation of the nerves and to prevent their injury during surgery. IONM permits nerve identification using an electrode, where, in order to measure the nerve response, the electric field is converted to an acoustic signal., Objectives: To assess the effects of IONM versus visual nerve identification for the prevention of RILN injury in adults undergoing thyroid surgery., Search Methods: We searched CENTRAL, MEDLINE, Embase, ICTRP Search Portal and ClinicalTrials.gov. The date of the last search of all databases was 21 August 2018. We did not apply any language restrictions., Selection Criteria: We included randomised controlled trials (RCTs) comparing IONM nerve identification plus visual nerve identification versus visual nerve identification alone for prevention of RILN injury in adults undergoing thyroid surgery DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles and abstracts for relevance. One review author carried out screening for inclusion, data extraction and 'Risk of bias' assessment and a second review author checked them. For dichotomous outcomes, we calculated risk ratios (RRs) with 95% confidence intervals (CIs). For continuous outcomes, we calculated mean differences (MDs) with 95% CIs. We assessed trials for certainty of the evidence using the GRADE instrument., Main Results: Five RCTs with 1558 participants (781 participants were randomly assigned to IONM and 777 to visual nerve identification only) met the inclusion criteria; two trials were performed in Poland and one trial each was performed in China, Korea and Turkey. Inclusion and exclusion criteria differed among trials: previous thyroid or parathyroid surgery was an exclusion criterion in three trials. In contrast, this was a specific inclusion criterion in another trial. Three trials had central neck compartment dissection or lateral neck dissection and Graves' disease as exclusion criteria. The mean duration of follow-up ranged from 6 to 12 months. The mean age of participants ranged between 41.7 years and 51.9 years.There was no firm evidence of an advantage or disadvantage comparing IONM with visual nerve identification only for permanent RILN palsy (RR 0.77, 95% CI 0.33 to 1.77; P = 0.54; 4 trials; 2895 nerves at risk; very low-certainty evidence) or transient RILN palsy (RR 0.62, 95% CI 0.35 to 1.08; P = 0.09; 4 trials; 2895 nerves at risk; very low-certainty evidence). None of the trials reported health-related quality of life. Transient hypoparathyroidism as an adverse event was not substantially different between intervention and comparator groups (RR 1.25; 95% CI 0.45 to 3.47; P = 0.66; 2 trials; 286 participants; very low-certainty evidence). Operative time was comparable between IONM and visual nerve monitoring alone (MD 5.5 minutes, 95% CI -0.7 to 11.8; P = 0.08; 3 trials; 1251 participants; very low-certainty evidence). Three of five included trials provided data on all-cause mortality: no deaths were reported. None of the trials reported socioeconomic effects. The evidence reported in this review was mostly of very low certainty, particularly because of risk of bias, a high degree of imprecision due to wide confidence intervals and substantial between-study heterogeneity., Authors' Conclusions: Results from this systematic review and meta-analysis indicate that there is currently no conclusive evidence for the superiority or inferiority of IONM over visual nerve identification only on any of the outcomes measured. Well-designed, executed, analysed and reported RCTs with a larger number of participants and longer follow-up, employing the latest IONM technology and applying new surgical techniques are needed.

Background: This is an update of the original review published in 2007.Carcinoma of the rectum is a common malignancy, especially in high income countries. Local recurrence may occur after surgery alone. Preoperative radiotherapy (PRT) has the potential to reduce the risk of local recurrence and improve outcomes in rectal cancer., Objectives: To determine the effect of preoperative radiotherapy for people with localised resectable rectal cancer compared to surgery alone., Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library; Issue 5, 2018) (4 June 2018), MEDLINE (Ovid) (1950 to 4 June 2018), and Embase (Ovid) (1974 to 4 June 2018). We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) for relevant ongoing trials (4 June 2018)., Selection Criteria: We included randomised controlled trials comparing PRT and surgery with surgery alone for people with localised advanced rectal cancer planned for radical surgery. We excluded trials that did not use contemporary radiotherapy techniques (with more than two fields to the pelvis)., Data Collection and Analysis: Two review authors independently assessed the 'Risk of bias' domains for each included trial, and extracted data. For time-to-event data, we calculated the Peto odds ratio (Peto OR) and variances, and for dichotomous data we calculated risk ratios (RR) using the random-effects method. Potential sources of heterogeneity hypothesised a priori included study quality, staging, and the use of total mesorectal excision (TME) surgery., Main Results: We included four trials with a total of 4663 participants. All four trials reported short PRT courses, with three trials using 25 Gy in five fractions, and one trial using 20 Gy in four fractions. Only one study specifically required TME surgery for inclusion, whereas in another study 90% of participants received TME surgery.Preoperative radiotherapy probably reduces overall mortality at 4 to 12 years' follow-up (4 trials, 4663 participants; Peto OR 0.90, 95% CI 0.83 to 0.98; moderate-quality evidence). For every 1000 people who undergo surgery alone, 454 would die compared with 45 fewer (the true effect may lie between 77 fewer to 9 fewer) in the PRT group. There was some evidence from subgroup analyses that in trials using TME no or little effect of PRT on survival (P = 0.03 for the difference between subgroups).Preoperative radiotherapy may have little or no effect in reducing cause-specific mortality for rectal cancer (2 trials, 2145 participants; Peto OR 0.89, 95% CI 0.77 to 1.03; low-quality evidence).We found moderate-quality evidence that PRT reduces local recurrence (4 trials, 4663 participants; Peto OR 0.48, 95% CI 0.40 to 0.57). In absolute terms, 161 out of 1000 patients receiving surgery alone would experience local recurrence compared with 83 fewer with PRT. The results were consistent in TME and non-TME studies.There may be little or no difference in curative resection (4 trials, 4673 participants; RR 1.00, 95% CI 0.97 to 1.02; low-quality evidence) or in the need for sphincter-sparing surgery (3 trials, 4379 participants; RR 0.99, 95% CI 0.94 to 1.04; I 2 = 0%; low-quality evidence) between PRT and surgery alone.Low-quality evidence suggests that PRT may increase the risk of sepsis from 13% to 16% (2 trials, 2698 participants; RR 1.25, 95% CI 1.04 to 1.52) and surgical complications from 25% to 30% (2 trials, 2698 participants; RR 1.20, 95% CI 1.01 to 1.42) compared to surgery alone.Two trials evaluated quality of life using different scales. Both studies concluded that sexual dysfunction occurred more in the PRT group. Mixed results were found for faecal incontinence, and irradiated participants tended to resume work later than non-irradiated participants between 6 and 12 months, but this effect had attenuated after 18 months (low-quality evidence)., Authors' Conclusions: We found moderate-quality evidence that PRT reduces overall mortality. Subgroup analysis did not confirm this effect in people undergoing TME surgery. We found consistent evidence that PRT reduces local recurrence. Risk of sepsis and postsurgical complications may be higher with PRT.The main limitation of the findings of the present review concerns their applicability. The included trials only assessed short-course radiotherapy and did not use chemotherapy, which is widely used in the contemporary management of rectal cancer disease. The differences between the trials regarding the criteria used to define rectal cancer, staging, radiotherapy delivered, the time between radiotherapy and surgery, and the use of adjuvant or postoperative therapy did not appear to influence the size of effect across the studies.Future trials should focus on identifying participants that are most likely to benefit from PRT especially in terms of improving local control, sphincter preservation, and overall survival while reducing acute and late toxicities (especially rectal and sexual function), as well as determining the effect of radiotherapy when chemotherapy is used and the optimal timing of surgery following radiotherapy.

Background: Diverticular disease is a common condition in Western industrialised countries. Most individuals remain asymptomatic throughout life; however, 25% experience acute diverticulitis. The standard treatment for acute diverticulitis is open surgery. Laparoscopic surgery - a minimal-access procedure - offers an alternative approach to open surgery, as it is characterised by reduced operative stress that may translate into shorter hospitalisation and more rapid recovery, as well as improved quality of life., Objectives: To evaluate the effectiveness of laparoscopic surgical resection compared with open surgical resection for individuals with acute sigmoid diverticulitis., Search Methods: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2) in the Cochrane Library; Ovid MEDLINE (1946 to 23 February 2017); Ovid Embase (1974 to 23 February 2017); clinicaltrials.gov (February 2017); and the World Health Organization (WHO) International Clinical Trials Registry (February 2017). We reviewed the bibliographies of identified trials to search for additional studies., Selection Criteria: We included randomised controlled trials comparing elective or emergency laparoscopic sigmoid resection versus open surgical resection for acute sigmoid diverticulitis., Data Collection and Analysis: Two review authors independently selected studies, assessed the domains of risk of bias from each included trial, and extracted data. For dichotomous outcomes, we calculated risk ratios (RRs) with 95% confidence intervals (CIs). For continuous outcomes, we planned to calculate mean differences (MDs) with 95% CIs for outcomes such as hospital stay, and standardised mean differences (SMDs) with 95% CIs for quality of life and global rating scales, if researchers used different scales., Main Results: Three trials with 392 participants met the inclusion criteria. Studies were conducted in three European countries (Switzerland, Netherlands, and Germany). The median age of participants ranged from 62 to 66 years; 53% to 64% were female. Inclusion criteria differed among studies. One trial included participants with Hinchey I characteristics as well as those who underwent Hartmann's procedure; the second trial included only participants with "a proven stage II/III disease according to the classification of Stock and Hansen"; the third trial considered for inclusion patients with "diverticular disease of sigmoid colon documented by colonoscopy and 2 episodes of uncomplicated diverticulitis, one at least being documented with CT scan, 1 episode of complicated diverticulitis, with a pericolic abscess (Hinchey stage I) or pelvic abscess (Hinchey stage II) requiring percutaneous drainage."We determined that two studies were at low risk of selection bias; two that reported considerable dropouts were at high risk of attrition bias; none reported blinding of outcome assessors (unclear detection bias); and all were exposed to performance bias owing to the nature of the intervention.Available low-quality evidence suggests that laparoscopic surgical resection may lead to little or no difference in mean hospital stay compared with open surgical resection (3 studies, 360 participants; MD -0.62 (days), 95% CI -2.49 to 1.25; I² = 0%).Low-quality evidence suggests that operating time was longer in the laparoscopic surgery group than in the open surgery group (3 studies, 360 participants; MD 49.28 (minutes), 95% CI 40.64 to 57.93; I² = 0%).We are uncertain whether laparoscopic surgery improves postoperative pain between day 1 and day 3 more effectively than open surgery. Low-quality evidence suggests that laparoscopic surgery may improve postoperative pain at the fourth postoperative day more effectively than open surgery (2 studies, 250 participants; MD = -0.65, 95% CI -1.04 to -0.25).Researchers reported quality of life differently across trials, hindering the possibility of meta-analysis. Low-quality evidence from one trial using the Short Form (SF)-36 questionnaire six weeks after surgery suggests that laparoscopic intervention may improve quality of life, whereas evidence from two other trials using the European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) v3 and the Gastrointestinal Quality of Life Index score, respectively, suggests that laparoscopic surgery may make little or no difference in improving quality of life compared with open surgery.We are uncertain whether laparoscopic surgery improves the following outcomes: 30-day postoperative mortality, early overall morbidity, major and minor complications, surgical complications, postoperative times to liquid and solid diets, and reoperations due to anastomotic leak., Authors' Conclusions: Results from the present comprehensive review indicate that evidence to support or refute the safety and effectiveness of laparoscopic surgery versus open surgical resection for treatment of patients with acute diverticular disease is insufficient. Well-designed trials with adequate sample size are needed to investigate the efficacy of laparoscopic surgery towards important patient-oriented (e.g. postoperative pain) and health system-oriented outcomes (e.g. mean hospital stay).

Background: People with abdominal aortic aneurysm who receive endovascular aneurysm repair (EVAR) need lifetime surveillance to detect potential endoleaks. Endoleak is defined as persistent blood flow within the aneurysm sac following EVAR. Computed tomography (CT) angiography is considered the reference standard for endoleak surveillance. Colour duplex ultrasound (CDUS) and contrast-enhanced CDUS (CE-CDUS) are less invasive but considered less accurate than CT., Objectives: To determine the diagnostic accuracy of colour duplex ultrasound (CDUS) and contrast-enhanced-colour duplex ultrasound (CE-CDUS) in terms of sensitivity and specificity for endoleak detection after endoluminal abdominal aortic aneurysm repair (EVAR)., Search Methods: We searched MEDLINE, Embase, LILACS, ISI Conference Proceedings, Zetoc, and trial registries in June 2016 without language restrictions and without use of filters to maximize sensitivity., Selection Criteria: Any cross-sectional diagnostic study evaluating participants who received EVAR by both ultrasound (with or without contrast) and CT scan assessed at regular intervals., Data Collection and Analysis: Two pairs of review authors independently extracted data and assessed quality of included studies using the QUADAS 1 tool. A third review author resolved discrepancies. The unit of analysis was number of participants for the primary analysis and number of scans performed for the secondary analysis. We carried out a meta-analysis to estimate sensitivity and specificity of CDUS or CE-CDUS using a bivariate model. We analysed each index test separately. As potential sources of heterogeneity, we explored year of publication, characteristics of included participants (age and gender), direction of the study (retrospective, prospective), country of origin, number of CDUS operators, and ultrasound manufacturer., Main Results: We identified 42 primary studies with 4220 participants. Twenty studies provided accuracy data based on the number of individual participants (seven of which provided data with and without the use of contrast). Sixteen of these studies evaluated the accuracy of CDUS. These studies were generally of moderate to low quality: only three studies fulfilled all the QUADAS items; in six (40%) of the studies, the delay between the tests was unclear or longer than four weeks; in eight (50%), the blinding of either the index test or the reference standard was not clearly reported or was not performed; and in two studies (12%), the interpretation of the reference standard was not clearly reported. Eleven studies evaluated the accuracy of CE-CDUS. These studies were of better quality than the CDUS studies: five (45%) studies fulfilled all the QUADAS items; four (36%) did not report clearly the blinding interpretation of the reference standard; and two (18%) did not clearly report the delay between the two tests.Based on the bivariate model, the summary estimates for CDUS were 0.82 (95% confidence interval (CI) 0.66 to 0.91) for sensitivity and 0.93 (95% CI 0.87 to 0.96) for specificity whereas for CE-CDUS the estimates were 0.94 (95% CI 0.85 to 0.98) for sensitivity and 0.95 (95% CI 0.90 to 0.98) for specificity. Regression analysis showed that CE-CDUS was superior to CDUS in terms of sensitivity (LR Chi 2 = 5.08, 1 degree of freedom (df); P = 0.0242 for model improvement).Seven studies provided estimates before and after administration of contrast. Sensitivity before contrast was 0.67 (95% CI 0.47 to 0.83) and after contrast was 0.97 (95% CI 0.92 to 0.99). The improvement in sensitivity with of contrast use was statistically significant (LR Chi 2 = 13.47, 1 df; P = 0.0002 for model improvement).Regression testing showed evidence of statistically significant effect bias related to year of publication and study quality within individual participants based CDUS studies. Sensitivity estimates were higher in the studies published before 2006 than the estimates obtained from studies published in 2006 or later (P < 0.001); and studies judged as low/unclear quality provided higher estimates in sensitivity. When regression testing was applied to the individual based CE-CDUS studies, none of the items, namely direction of the study design, quality, and age, were identified as a source of heterogeneity.Twenty-two studies provided accuracy data based on number of scans performed (of which four provided data with and without the use of contrast). Analysis of the studies that provided scan based data showed similar results. Summary estimates for CDUS (18 studies) showed 0.72 (95% CI 0.55 to 0.85) for sensitivity and 0.95 (95% CI 0.90 to 0.96) for specificity whereas summary estimates for CE-CDUS (eight studies) were 0.91 (95% CI 0.68 to 0.98) for sensitivity and 0.89 (95% CI 0.71 to 0.96) for specificity., Authors' Conclusions: This review demonstrates that both ultrasound modalities (with or without contrast) showed high specificity. For ruling in endoleaks, CE-CDUS appears superior to CDUS. In an endoleak surveillance programme CE-CDUS can be introduced as a routine diagnostic modality followed by CT scan only when the ultrasound is positive to establish the type of endoleak and the subsequent therapeutic management.

Background: Dementia is a common and serious neuropsychiatric syndrome, characterised by progressive cognitive and functional decline. The majority of people with dementia develop behavioural disturbances, also known as behavioural and psychological symptoms of dementia (BPSD). Several non-pharmacological interventions have been evaluated to treat BPSD in people with dementia. Simulated presence therapy (SPT), an intervention that uses video or audiotape recordings of family members played to the person with dementia, is a possible approach to treat BPSD., Objectives: To assess the effects of SPT on behavioural and psychological symptoms and quality of life in people with dementia., Search Methods: We searched ALOIS (the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group), CENTRAL (The Cochrane Library) (9 February 2016), MEDLINE Ovid SP (1946 to 6 January 2017), Embase Ovid SP (1972 to 6 January 2017), PsycINFO Ovid SP (1806 to 6 January 2017), CINAHL via EBSCOhost (1980 to 6 January 2017), LILACS via BIREME (all dates to 6 January 2017), ClinicalTrials.gov (ClinicalTrials.gov) (all dates to 6 January 2017), and the World Health Organization (WHO) Portal (apps.who.int/trialsearch) (all dates to 6 January 2017). We also checked the reference lists of relevant articles to identify any additional studies., Selection Criteria: Randomised and quasi-randomised controlled trials, including cross-over studies, that evaluated the efficacy of SPT, consisting of personalised audio or videotape recordings of family members, in people with any form of dementia., Data Collection and Analysis: Two authors independently selected studies, assessed risk of bias and extracted data. No meta-analyses were conducted because of substantial heterogeneity among the included studies., Main Results: Three trials with 144 participants met the inclusion criteria. Two of the trials had a randomised cross-over design, one was a cross-over trial which we classified as quasi-randomised.Participants in the included studies were people with dementia living in nursing homes. They were predominantly women and had a mean age of over 80 years. SPT was performed using an audio or video recording prepared by family members or surrogates. It varied in its content, frequency of administration and duration. All the studies compared multiple treatments. In one study, SPT was compared with two other interventions; in the other two studies, it was compared with three other interventions. Specifically, SPT was compared to usual care, personalised music (two studies), a 'placebo' audiotape containing the voice of a person (two studies), and one-to-one social interaction performed by trained research assistants (one study). In terms of outcomes evaluated, one study considered agitation and withdrawn behaviour (both assessed with three methods); the second study evaluated verbal disruptive behaviour (assessed with three methods); and the third study evaluated physically agitated behaviour and verbally agitated behaviour (the method used was not clearly described).According to the GRADE criteria, the overall quality of the evidence was very low due to very small numbers of participants and risk of bias in the included studies; (none of the trials was at low risk of selection bias; all the trials were at high risk of performance bias; one trial was at high risk of attrition bias; and all had unclear selective reporting).Because of variation in the participants, the format of SPT, the comparison interventions, and the measures used to assess outcomes, we judged the results unsuitable for a meta-analysis.Within each trial, the effect of SPT on behaviour, compared to usual care, was mixed and depended on the measure used. Two trials which included a personalised music intervention reported no significant differences between simulated presence and music on behavioural outcomes. Because the overall quality of the evidence was very low, we were very uncertain regarding all the resultsNone of the studies evaluated quality of life or any of our secondary outcome measures (performance of activities of daily living, dropout and carer burden)., Authors' Conclusions: We were unable to draw any conclusions about the efficacy of SPT for treating behavioural and psychological symptoms and improving quality of life of people with dementia. New high-quality studies are needed to investigate the effect of SPT.

Background: Despite considerable improvements in oral health, dental caries continue to be a public health issue. The most frequently used, and universally accepted technique, to remove caries is through mechanical ablation of decayed tissues by means of rotating drills (diamond or tungsten carbide, or both). In the past few decades, the introduction of adhesive filling materials (resin composites) has affected cavity filling procedures by reducing its retention needs, with advantages for dental tissue conservation. Consequently, new minimally invasive strategies were introduced into dental practice, such as the use of lasers to perform highly controlled tissue ablation. Laser use has also raised expectations of limiting pain and discomfort compared to using drills, as well as overcoming drill phobia., Objectives: The main objective of the review was to compare the effects of laser-based methods to conventional mechanical methods for removing dental caries in deciduous and permanent teeth., Search Methods: We searched the following electronic databases: Cochrane Oral Health's Trials Register (searched 22 June 2016), Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 5) in the Cochrane Library (searched 22 June 2016), MEDLINE Ovid (1946 to 22 June 2016), Embase Ovid (1980 to 22 June 2016), ProQuest Dissertations and Theses (1980 to 22 June 2016), Zetoc (limited to conference proceedings) (1993 to 22 June 2016), and ISI Web of Knowledge (limited to conference proceedings) (1990 to 22 June 2016). We checked the reference lists of relevant articles to identify additional studies. We searched the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials., Selection Criteria: We included randomised controlled trials, split-mouth trials and cluster-randomised trials (irrespective of their language) comparing laser therapy to drill ablation of caries. We included participants of any age (children, adolescents and adults)., Data Collection and Analysis: Two review authors independently screened titles and abstracts of citations identified by the review search strategy. Two review authors independently evaluated the full text of relevant primary studies, assessed risk of bias and extracted data. We used standard methodological procedures expected by Cochrane., Main Results: We included nine randomised trials, published between 1998 and 2014, involving 662 participants. The population consisted of both children and adolescents in four trials, only adults in four trials, and both children/adolescents and adults in one trial. Four studies examined only permanent teeth, and five studies evaluated both deciduous and permanent teeth. Six trials used Er:YAG (erbium-doped yttrium aluminium garnet) lasers, two trials employed Er,Cr:YSGG (erbium, chromium: yttrium-scandium-gallium-garnet) lasers, and one trial used Nd:YAG (neodymium-doped yttrium aluminium garnet) laser.Overall, the trials had small sample sizes, and the majority were at unclear or high risk of bias. The primary outcomes were evaluated in a limited number of trials (removal of caries (four trials (but only two reported quantitative data)); episodes of pain (five studies)). There was insufficient evidence to suggest that either lasers or drill were better at caries removal (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.99 to 1.01; 2 studies; 256 treated caries; P = 0.75; I 2 = 0%; low-quality evidence).The incidence of moderate or high pain was greater in the drill group compared to the laser group (RR 0.40, 95% CI 0.28 to 0.57; 2 studies; 143 participants; P < 0.001; I 2 = 50%). Similarly, the need for anaesthesia was significantly higher in the drill group than in the laser group (RR 0.25, 95% CI 0.10 to 0.65; 3 studies; 217 children/adolescents; P = 0.004; I 2 = 0%).In terms of marginal integrity of restoration, there was no evidence of a difference between laser and drill comparisons evaluated at 6 months (RR 1.00, 95% CI 0.21 to 4.78; 3 studies), 1 year (RR 1.59, 95% CI 0.34 to 7.38; 2 studies), or 2 years (RR 1.00, 95% CI 0.21 to 4.74; 1 study).There was no evidence of a difference for durability of restoration between laser therapy or drill at 6 months' follow-up (RR 2.40, 95% CI 0.65 to 8.77; 4 studies), at 1 year (RR 1.40, 95% CI 0.29 to 6.78; 2 studies) or at 2 years' follow-up (RR 0.50, 95% CI 0.02 to 14.60; 1 study).Only two trials investigated the recurrence of caries, but no events occurred during 6 months' follow-up.There was insufficient evidence of a difference between laser or drill in terms of pulpal inflammation or necrosis at 1 week (RR 1.51, 95% CI 0.26 to 8.75; 3 studies) and at 6 months (RR 0.99, 95% CI 0.10 to 9.41; 2 studies)., Authors' Conclusions: Given the low quality of the body of evidence, we concluded that evidence was insufficient to support the use of laser as an alternative to traditional drill therapy for caries removal. We found some evidence in favour of laser therapy for pain control, need of anaesthesia and patient discomfort, but, again, the body of evidence was of low quality. Additional well-designed, randomised trials investigating the most relevant outcomes are needed.

Background: Thoracic aortic aneurysm (TAA) is an uncommon disease with an incidence of 10.4 per 100,000 inhabitants. It occurs mainly in older individuals and is evenly distributed among both sexes. There are no signs or symptoms indicative of the presence of the disease. Progressive but unpredictable enlargement of the dilated aorta is the natural course of the disease and can lead to rupture. Open chest surgical repair using prosthetic graft interposition has been a conventional treatment for TAAs. Despite improvements in surgical procedures perioperative complications remain significant. The alternative option of thoracic endovascular aneurysm repair (TEVAR) is considered a less invasive and potentially safer technique, with lower morbidity and mortality compared with conventional treatment. Evidence is needed to support the use of TEVAR for these patients, rather than open surgery. This is an update of the review first published in 2009., Objectives: This review aimed to assess the efficacy of TEVAR versus conventional open surgery in patients with thoracic aortic aneurysms., Search Methods: For this update the Cochrane Vascular Information Specialist searched the Specialised Register (last searched January 2016) and CENTRAL (2015, Issue 12)., Selection Criteria: Randomised controlled trials in which patients with TAAs were randomly assigned to TEVAR or open surgical repair., Data Collection and Analysis: Two review authors independently identified and evaluated potential trials for eligibility. Excluded studies were further checked by another author. We did not perform any statistical analyses as no randomised controlled trials were identified., Main Results: We did not find any published or unpublished randomised controlled trials comparing TEVAR with conventional open surgical repair for the treatment of thoracic aortic aneurysms., Authors' Conclusions: Stent grafting of the thoracic aorta is technically feasible and non-randomised studies suggest reduction of early outcomes such as paraplegia, mortality and hospital stay. High quality randomised controlled trials assessing all clinically relevant outcomes including open-conversion, aneurysm exclusion, endoleaks, and late mortality are needed.

Background: Fresh frozen plasma (FFP) is a blood component containing procoagulant factors, which is sometimes used in cardiovascular surgery with the aim of reducing the risk of bleeding. The purpose of this review is to assess the risk of mortality for patients undergoing cardiovascular surgery who receive FFP., Objectives: To evaluate the risk to benefit ratio of FFP transfusion in cardiovascular surgery for the treatment of bleeding patients or for prophylaxis against bleeding., Search Methods: We searched 11 bibliographic databases and four ongoing trials databases including the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2015), MEDLINE (OvidSP, 1946 to 21 April 2015), EMBASE (OvidSP, 1974 to 21 April 2015), PubMed (e-publications only: searched 21 April 2015), ClinicalTrials.gov, World Health Organization (WHO) ICTRP and the ISRCTN Register (searched 21 April 2015). We also searched the references of all identified trials and relevant review articles. We did not limit the searches by language or publication status., Selection Criteria: We included randomised controlled trials in patients undergoing major cardiac or vascular surgery who were allocated to a FFP group or a comparator (no plasma or an active comparator, either clinical plasma (any type) or a plasma-derived blood product). We included participants of any age (neonates, children and adults). We excluded studies of plasmapheresis and plasma exchange., Data Collection and Analysis: Two authors screened all electronically derived citations and abstracts of papers identified by the review search strategy. Two authors assessed risk of bias in the included studies and extracted data independently. We took care to note whether FFP was used therapeutically or prophylactically within each trial., Main Results: We included 15 trials, with a total of 755 participants for analysis in the review. Fourteen trials compared prophylactic use of FFP against no FFP. One study compared therapeutic use of two types of plasma. The timing of intervention varied, including FFP transfusion at the time of heparin neutralisation and stopping cardiopulmonary bypass (CPB) (seven trials), with CPB priming (four trials), after anaesthesia induction (one trial) and postoperatively (two trials). Twelve trials excluded patients having emergency surgery and nine excluded patients with coagulopathies.Overall the trials were small, with only four reporting an a priori sample size calculation. No trial was powered to determine changes in mortality as a primary outcome. There was either high risk of bias, or unclear risk, in the majority of trials included in this review.There was no difference in the number of deaths between the intervention arms in the six trials (with 287 patients) reporting mortality (very low quality evidence). There was also no difference in blood loss in the first 24 hours for neonatal/paediatric patients (four trials with 138 patients; low quality evidence): mean difference (MD) -1.46 ml/kg (95% confidence interval (CI) -4.7 to 1.78 ml/kg); or adult patients (one trial with 120 patients): MD -12.00 ml (95% CI -101.16 to 77.16 ml).Transfusion with FFP was inferior to control for preventing patients receiving any red cell transfusion: Peto odds ratio (OR) 2.57 (95% CI 1.30 to 5.08; moderate quality evidence). There was a difference in prothrombin time within two hours of FFP transfusion in eight trials (with 210 patients; moderate quality evidence) favouring the FFP arm: MD -0.71 seconds (95% CI -1.28 to -0.13 seconds). There was no difference in the risk of returning to theatre for reoperation (eight trials with 398 patients; moderate quality evidence): Peto OR 0.81 (95% CI 0.26 to 2.57). Only one included study reported adverse events as an outcome and reported no significant adverse events following FFP transfusion., Authors' Conclusions: This review has found no evidence to support the prophylactic administration of FFP to patients without coagulopathy undergoing elective cardiac surgery. There was insufficient evidence about treatment of patients with coagulopathies or those who are undergoing emergency surgery. There were no reported adverse events attributable to FFP transfusion, although there was a significant increase in the number of patients requiring red cell transfusion who were randomised to FFP. Variability in outcome reporting between trials precluded meta-analysis for many outcomes across all trials, and there was evidence of a high risk of bias in most of the studies. Further adequately powered studies of FFP, or comparable pro-haemostatic agents, are required to assess whether larger reductions in prothrombin time translate into clinical benefits. Overall the evidence from randomised controlled trials for the safety and efficacy of prophylactic transfusion of FFP for cardiac surgery is insufficient.

Background: Glycoprotein (GP) IIb-IIIa inhibitors are antiplatelet agents that act by antagonising GP IIb-IIIa receptors on the platelet surface and block the final common pathway to platelet aggregation by preventing the binding of fibrinogen molecules that form bridges between adjacent platelets. Thus, GP IIb-IIIa inhibitors could favour endogenous thrombolysis by reducing thrombus growth and preventing thrombus re-formation through competitive inhibition with fibrinogen and, due to their mechanism of action, are likely to have a more profound antiplatelet effect with more rapid onset than conventional antiplatelet agents, such as aspirin or clopidogrel. Currently used in clinical practice for the treatment of individuals with acute coronary syndromes and during coronary angioplasty, GP IIb-IIIa inhibitors could also be useful for the treatment of people with acute ischaemic stroke., Objectives: To assess the use of GP IIb-IIIa inhibitors in people with acute ischaemic stroke to evaluate whether such treatments (1) reduce the proportion of patients who die or remain dependent, and (2) are sufficiently safe for general use. We wished to examine the effects GP IIb-IIIa inhibitors alone or in combination with thrombolytic agents., Search Methods: We searched the Cochrane Stroke Group trials register (last searched 10 June 2013), MEDLINE (1966 to June 2013), EMBASE (1980 to June 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 5, 2013), and major ongoing clinical trials registers (June 2013). We also searched reference lists and contacted trial authors and pharmaceutical companies., Selection Criteria: We aimed to analyse unconfounded randomised controlled trials (RCTs) of GP IIb-IIIa inhibitors in the treatment of people with acute ischaemic stroke. Only individuals who started treatment within six hours of stroke onset were included., Data Collection and Analysis: We independently selected trials for inclusion, assessed trial quality and extracted the data., Main Results: We included four trials involving 1365 participants. Three trials compared the intravenous GP IIb-IIIa inhibitor Abciximab with intravenous placebo (1215 participants) and one trial compared the intravenous GP IIb-IIIa inhibitor Tirofiban with intravenous aspirin (150 participants). Treatment with either of these GP IIb-IIIa inhibitors did not significantly reduce long-term death or dependency (odds ratio (OR) 0.97, 95% confidence interval (CI) 0.77 to 1.22, for the comparison between Abciximab and placebo; OR 1.00, 95% CI 0.52 to 1.92, for the comparison between Tirofiban and aspirin) and had no effect on deaths from all causes (OR 1.08, 95% CI 0.77 to 1.53, for the comparison between Abciximab and placebo; OR 1.00, 95% CI 0.35 to 2.82, for the comparison between Tirofiban and aspirin). Abciximab was associated with a significant increase in symptomatic intracranial haemorrhage (OR 4.6, 95% CI 2.01 to 10.54) and with a non-significant increase in major extracranial haemorrhage (OR 1.81, 95% CI 0.96 to 3.41), whereas the only small trial comparing Tirofiban with aspirin showed no increased risk of bleeding complications with Tirofiban (OR 0.32, 95% CI 0.03 to 3.19, for symptomatic intracranial haemorrhage; OR 3.04, 95% CI 0.12 to 75.83, for major extracranial haemorrhages). There was no significant inconsistency across the studies., Authors' Conclusions: The available trial evidence showed that, for individuals with acute ischaemic stroke, GP IIb-IIIa inhibitors are associated with a significant risk of intracranial haemorrhage with no evidence of any reduction in death or disability in survivors. These data do not support their routine use in clinical practice. The conclusion is driven by trials of Abciximab, which contributed 89% of the total number of study participants considered.

Background: Thoracic aortic aneurysm (TAA) is an uncommon disease with an incidence of 10.4 per 100,000 inhabitants. It occurs mainly in older individuals and is evenly distributed among both sexes. There are no signs or symptoms indicative of the presence of the disease. Progressive but unpredictable enlargement of the dilated aorta is the natural course of the disease and can lead to rupture. Open chest surgical repair using prosthetic graft interposition has been a conventional treatment for TAAs. Despite improvements in surgical procedures perioperative complications remain significant. The alternative option of thoracic endovascular aneurysm repair (TEVAR) is considered a less invasive and potentially safer technique, with lower morbidity and mortality compared with conventional treatment. Evidence is needed to support the use of TEVAR for these patients, rather than open surgery., Objectives: The aim of this review is to assess the efficacy of TEVAR versus conventional open surgery in patients with TAAs., Search Methods: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched March 2013) and CENTRAL (2013, Issue 2)., Selection Criteria: Randomised controlled trials in which patients with TAAs were randomly assigned to TEVAR or open surgical repair., Data Collection and Analysis: Two review authors independently identified and evaluated potential trials for eligibility. Excluded studies were further checked by another author. We did not perform any statistical analyses as no randomised controlled trials were identified., Main Results: We did not find any published or unpublished randomised controlled trials comparing TEVAR with conventional open surgical repair for the treatment of thoracic aortic aneurysms., Authors' Conclusions: Though stent grafting of the thoracic aorta is technically feasible and non-randomised studies suggest reduction of early outcomes such as paraplegia, mortality and hospital stay, high quality randomised controlled trials assessing all clinically relevant outcomes including open-conversion, aneurysm exclusion, endoleaks, and late mortality are needed.

Background: Trauma is one of the leading causes of death in any age group. The 'lethal triad' of acidosis, hypothermia, and coagulopathy has been recognized as a significant cause of death in patients with traumatic injuries. In order to prevent the lethal triad two factors are essential, early control of bleeding and prevention of further heat loss. In patients with major abdominal trauma, damage control surgery (DCS) avoids extensive procedures on unstable patients, stabilizes potentially fatal problems at initial operation, and applies staged surgery after successful initial resuscitation. It is not currently known whether DCS is superior to immediate surgery for patients with major abdominal trauma., Objectives: To assess the effects of damage control surgery compared to traditional immediate definitive surgical treatment for patients with major abdominal trauma., Search Methods: We searched the Cochrane Injuries Group Specialised Register, CENTRAL (The Cochrane Library 2012, Issue 12 of 12), MEDLINE, EMBASE, Web of Science: Science Citation Index & ISI Proceedings, Current Controlled Trials MetaRegister, Clinicaltrials.gov, Zetoc, and CINAHL for all published and unpublished randomised controlled trials. We did not restrict the searches by language, date, or publication status. The search was through December 2012., Selection Criteria: Randomised controlled trials of damage control surgery versus immediate traditional surgical repair were included in this review. We included patients with major abdominal trauma (Abbreviated Injury Scale > 3) who were undergoing surgery. Patient selection was crucial as patients with relatively simple abdominal injuries should not undergo unnecessary procedures., Data Collection and Analysis: Two authors independently evaluated the search results., Main Results: A total of 2551 studies were identified by our search. No randomised controlled trials comparing DCS with immediate and definitive repair in patients with major abdominal trauma were found. A total of 2551 studies were excluded because they were not relevant to the review topic and two studies were excluded with reasons after examining the full-text., Authors' Conclusions: Evidence that supports the efficacy of damage control surgery with respect to traditional laparotomy in patients with major abdominal trauma is limited.

Background: In a majority of patients with stage IV colorectal cancer, the metastatic disease is not resectable and the focus of management is on how best to palliate the patient. How to manage the primary tumour is an important part of palliation. A small proportion of these patients present with either obstructing or perforating cancers and require urgent surgical care. However, a majority are relatively asymptomatic from their primary cancer. Chemotherapy has been shown to prolong survival in this group of patients, and a majority of patients would be treated this way. Nonetheless, A recent meta-analysis (Stillwell 2010) suggests an improved overall survival and reduced requirement for emergency surgery in those patients who undergo primary tumour resection. This review was also able to quantify the mortality and morbidity associated with surgery to remove the primary., Objectives: To determine if there is an improvement in overall survival following resection of the primary cancer in patients with unresectable stage IV colorectal cancer and an asymptomatic primary who are treated with chemo/radiotherapy., Search Methods: In January 2012 we searched for published randomised and non-randomised controlled clinical trials without language restrictions using the following electronic databases: CENTRAL (the Cochrane Library (latest issue)), MEDLINE (1966 to date), EMBASE (1980 to date), Science Citation Index (1981 to date), ISI Proceedings (1990 to date), Current Controlled Trials MetaRegister (latest issue), Zetoc (latest issue) and CINAHL (1982 to date)., Selection Criteria: Randomised controlled trials and non-randomised controlled studies evaluating the influence on overall survival of primary tumour resection versus no resection in asymptomatic patients with unresectable stage IV colorectal cancer who are treated with palliative chemo/radiotherapy., Data Collection and Analysis: We conducted the review according to the recommendations of The Cochrane Collaboration and the Cochrane Colorectal Group. "Review Manager 5" software was used., Main Results: A total of 798 studies were identified following the initial search. No published or unpublished randomised controlled trials comparing primary tumour resection versus no resection in asymptomatic patients with unresectable stage IV colorectal cancer who were treated with chemo/radiotherapy were identified. Seven non-randomised studies, potentially eligible for inclusion, were identified: 2 case-matched studies, 2 CCTs and 3 retrospective cohort studies. Overall, these trials included 1.086 patients (722 patients treated with primary tumour resection, and 364 patients managed first with chemotherapy and/or radiotherapy)., Authors' Conclusions: Resection of the primary tumour in asymptomatic patients with unresectable stage IV colorectal cancer who are managed with chemo/radiotherapy is not associated with a consistent improvement in overall survival. In addition, resection does not significantly reduce the risk of complications from the primary tumour (i.e.  obstruction, perforation or bleeding). Yet there is enough doubt with regard to the published literature to justify further clinical trials in this area. The results from an ongoing high quality randomised controlled trial will help to answer this question.

Background: Colorectal cancer (CRC) is the most common malignant tumour and the third leading cause of cancer deaths in USA. For advanced CRC, the liver is the first site of metastatic disease; approximately 50 % of patients with CRC will develop liver metastases either synchronously or metachronously within 2 years after primary diagnosis. Hepatic resection (HR) is the only curative option, but only 15-20% of patients with liver metastases from CRC (CRLMs) are suitable for surgical standard treatment. In patients with unresectable CRLMs downsizing chemotherapy can improve resectability (16%). Modern systemic chemotherapy represents the only significant treatment for unresectable CRLMs. However several loco-regional treatments have been developed: hepatic arterial infusion (HAI), cryosurgical ablation (CSA), radiofrequency ablation (RFA), microwave ablation and selective internal radion treatment (SIRT). During the past decade RFA has superseded other ablative therapies, due to its low morbidity, mortality, safety and patient acceptability., Objectives: The objective of this study was to systematically review the role of radiofrequency ablation (RFA) in the treatment of CRLMs., Search Methods: We performed electronic searches in the following databases:CENTRAL, MEDLINE and EMBASE. Current trials were identified through the Internet using the Clinical-Trials.gov site (to January 2, 2012) and ASCO Proceedings. The reference lists of identified trials were reviewed for additional studies., Selection Criteria: Randomized clinical trials (RCTs), quasi-randomised or controlled clinical trials (CCTs) comparing RFA to any other therapy for CRLMs were included. Observational study designs including comparative cohort studies comparing RFA to another intervention, single arm cohort studies or case control studies have been included if they have: prospectively collected data, ten or more patients; and have a mean or median follow-up time of 24 months. Patients with CRLMs who have no contraindications for RFA. Patients with unresectable extra-hepatic disease were also included.Trials have been considered regardless of language of origin., Data Collection and Analysis: A total of 1144 records were identified through the above electronic searching. We included 18 studies: 10 observational studies, 7 Clinical Controlled Trials (CCTs) and an additional 1 Randomized Clinical Trial (RCT) (abstract) identified by hand searching in the 2010 ASCO Annual Meeting. The most appropriate way of summarizing time-to-event data is to use methods of survival analysis and express the intervention effect as a hazard ratio. In the included studies these outcome are mostly reported as dichotomous data so we should have asked authors research data for each participant and perform Individual Patient Data (IPD) meta-analysis. Given the study design and low quality of included studies we decided to give up and not to summarize these data., Main Results: Seventeen studies were not randomised and this increases the potential for selection bias. In addition, there was imbalance in the baseline characteristics of the participants included in all studies. All studies were classified as having a elevate risk of bias. The assessment of methodological quality of all non-randomized studies included in meta-analysis performed by the STROBE checklist has allowed us to identify several methodological limits in most of the analysed studies. At present, the information from the single RCT included (Ruers 2010) comes from an abstract of 2010 ASCO Annual Meeting where the allocation concealment was not reported; however in original protocol allocation concealment was adequately reported (EORTC 40004 protocol). The heterogeneity regarding interventions, comparisons and outcomes rendered the data not suitable., Authors' Conclusions: This systematic review gathers information from several controlled clinical trials and observational studies which are vulnerable to different types of bias. The imbalance between characteristics of patients in the allocated groups appears to be the main concern. Only one randomised clinical trial (published as an abstract), comparing 60 patients receiving RFA plus CT versus 59 patients receiving CT alone, was identified. This study showed that PFS was significantly higher in the group that received RFA. However, it was not able to provide information on overall survival. In conclusion, evidence from the included studies are insufficient to recommend RFA for a radical oncological treatment of CRLMs.

Background: Anastomotic leakage is one of the most important complications that occur after surgical low anterior resection for rectal cancer. There are indications that anastomotic leak is associated with increased morbidity, mortality, frequent re-operation or radiological drainage, and prolonged hospital stay. Defunctioning stoma can be useful for patients undergoing a rectal surgery., Objectives: To determine the efficacy of protective defunctioning stoma in low anterior resection for rectal carcinoma., Search Strategy: Searches were conducted November 2009. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 1966) and EMBASE (from 1980)., Selection Criteria: We included randomised clinical trials comparing the use of stoma versus "no stoma" in patients that received low anterior resection for rectal cancer., Data Collection and Analysis: Six randomised controlled trials were identified and included in this review. Five trials were fully published in peer-reviewed journals. An attempt was made to obtain further information from the authors of the trial that was available only in an abstract form. The studies analysed the following outcomes: clinical anastomotic leakage, urgent reoperation, mortality and length of postoperative hospital stay. Review authors extracted the data independently, the risk ratios (RR) were estimated for the dichotomous outcomes and standardised mean difference were estimated for the continuous outcome, Main Results: All the trials reported results for clinical anastomotic leakage, urgent reoperation and mortality. Only two trials reported the results for length of postoperative hospital stay.With respect to controls, use of covering stoma was significantly associated with less anastomotic leakage (RR 0.33; 95%CI [0.21, 0.53]) and less urgent reoperation (RR 0.23; 95%CI [0.12, 0.42] ). There was no significant difference in terms of mortality (RR 0.58; 95%CI [0.14, 2.33]). There was no evidence of statistical heterogeneity in any of the comparisons., Authors' Conclusions: Covering stoma seems to be useful to prevent anastomotic leakage and urgent re-operations in patients receiving low anterior resection for rectal cancer. However, covering stoma does not seems to offer advantage in term of 30 days or long term mortality.

Background: Acute intestinal obstruction is one of the most common surgical emergencies. The small bowel obstruction (SBO) is the site of obstruction in most patients (76%) and adhesions are the most common etiology (65%). Laparoscopy in SBO has no clear role yet as it may have a therapeutic and diagnostic function. In some settings laparoscopic or laparoscopy-assisted surgery is considered feasible and convenient more than conventional surgery for SBO; however little is known if laparoscopic or laparoscopy-assisted surgery is more suitable with respect to open surgery for patients with SBO., Objectives: The aim of this systematic review is to assess whether laparoscopic or laparoscopy-assisted surgery is feasible and safe for acute SBO, and whether laparoscopic and laparoscopy-assisted surgery present advantages compared to open surgery in terms of short-term and long-term outcomes., Search Strategy: We searched for published randomised and prospective controlled clinical trials without language restrictions using the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1950 onwards) and EMBASE (1980 onwards)., Selection Criteria: Randomised controlled trials and non randomised controlled prospective trials evaluating laparoscopic and laparoscopy-assisted surgery versus traditional open surgery for acute SBO were considered., Data Collection and Analysis: We conducted the review according to the recommendations of The Cochrane Collaboration and the Cochrane Colorectal Group as well, using Review Manager 5 to conduct the review., Main Results: No published or unpublished randomised controlled trials or prospective controlled clinical trials comparing laparoscopy with open surgery for patients with SBO were identified., Authors' Conclusions: Although data from retrospective clinical controlled trials suggest that laparoscopy seems feasible and better in terms of hospital stay and mortality reduction, high quality randomised controlled trials assessing all clinically relevant outcomes including overall mortality, morbidity, hospital stay and conversion are needed.

Background: Trauma is one of the leading causes of death in any age group. The 'lethal triad' of acidosis, hypothermia, and coagulopathy has been recognized as a significant cause of death in patients with traumatic injuries. In order to prevent the lethal triad two factors are essential, early control of bleeding and prevention of further heat loss. In patients with major abdominal trauma, damage control surgery (DCS) avoids extensive procedures on unstable patients, stabilizes potentially fatal problems at initial operation, and applies staged surgery after successful initial resuscitation. It is not currently known whether DCS is superior to immediate surgery for patients with major abdominal trauma., Objectives: To assess the effectiveness of DCS compared to traditional immediate definitive surgical treatment for patients with major abdominal trauma., Search Strategy: We searched the Cochrane Injuries Group Specialised Register, CENTRAL (The Cochrane Library 2008, Issue 3), MEDLINE, EMBASE, Web of Science: Science Citation Index & ISI Proceedings, Current Controlled Trials MetaRegister, Clinicaltrials.gov, Zetoc, and CINAHL for all published and unpublished randomised controlled trials. We did not restrict the searches by language, date, or publication status. Searches were conducted in August 2008., Selection Criteria: Randomised controlled trials of DCS versus immediate traditional surgical repair were included in this review. We included patients with major abdominal trauma (Abbreviated Injury Scale > 3) who were undergoing surgery. Patient selection was crucial as patients with relatively simple abdominal injuries should not undergo unnecessary procedures., Data Collection and Analysis: Two authors independently evaluated the search results., Main Results: A total of 1523 studies were identified by our search. No randomised controlled trials comparing DCS with immediate and definitive repair in patients with major abdominal trauma were found. A total of 1521 studies were excluded because they were not relevant to the review topic and two studies were excluded because they were case-control studies., Authors' Conclusions: Evidence that supports the efficacy of DCS with respect to traditional laparotomy in patients with major abdominal trauma is limited.

Background: Thoracic aortic aneurysm (TAA) is an uncommon disease with an incidence of 10.4 per 100,000 inhabitants. It occurs mainly in older individuals and is evenly distributed among both sexes. There are no signs or symptoms indicative of the presence of the disease. Progressive but unpredictable enlargement of the dilated aorta is the natural course of the disease and can lead to rupture. Open chest surgical repair using prosthetic graft interposition has been a conventional treatment for TAAs. Despite improvements in surgical procedures perioperative complications remain significant. The alternative option of thoracic endovascular aneurysm repair (TEVAR) is considered a less invasive and potentially safer technique, with lower morbidity and mortality compared with conventional treatment. Evidence is needed to support the use of TEVAR for these patients, rather than open surgery., Objectives: The aim of this review is to assess the efficacy of TEVAR versus conventional open surgery in patients with TAAs., Search Strategy: The Cochrane Peripheral Vascular Diseases Group searched their Trials Register (last searched 10 October 2008), the Cochrane Central Register of Controlled Trials database (CENTRAL) (last searched The Cochrane Library 2008, Issue 4)., Selection Criteria: Randomised controlled trials in which patients with TAAs were randomly assigned to TEVAR or open surgical repair., Data Collection and Analysis: Two review authors independently identified and evaluated potential trials for eligibility. Excluded studies were further checked by another author. We did not perform any statistical analyses as no randomised controlled trials were identified., Main Results: We did not find any published or unpublished randomised controlled trials comparing TEVAR with conventional open surgical repair for the treatment of thoracic aortic aneurysms., Authors' Conclusions: Though stent grafting of the thoracic aorta is technically feasible and non-randomised studies suggest reduction of early outcomes such as paraplegia, mortality and hospital stay, high quality randomised controlled trials assessing all clinically relevant outcomes including open-conversion, aneurysm exclusion, endoleaks, and late mortality are needed.

Background: Glycoprotein (GP) IIb-IIIa inhibitors block the final common pathway to platelet aggregation antagonising with receptors that bind fibrinogen molecules forming bridges between adjacent platelets. Thus, GP IIb-IIIa inhibitors could favour endogenous thrombolysis by reducing thrombus growth and prevent thrombus re-formation by competitive inhibition with fibrinogen. Currently used in clinical practice for acute coronary syndromes and percutaneous coronary interventions, they could also be useful for patients with acute ischaemic stroke., Objectives: To assess efficacy and safety of GP IIb-IIIa inhibitors in acute ischaemic stroke., Search Strategy: We searched the Cochrane Stroke Group trials register (last searched 31 May 2005). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2005), MEDLINE (1966 to June 2005) and EMBASE (1980 to June 2005). In an effort to identify further published, unpublished and ongoing trials we searched reference lists and contacted trial authors and pharmaceutical companies., Selection Criteria: We aimed to analyse unconfounded randomised controlled trials comparing GP IIb-IIIa inhibitors with placebo in patients with acute ischaemic stroke. Only patients who started the treatment within six hours of stroke onset were included., Data Collection and Analysis: Three review authors independently selected trials for inclusion, assessed trial quality and extracted the data., Main Results: Two trials involving 474 patients were included. Only data for 414 patients treated within six hours were considered. Patients were treated with intravenous abciximab or placebo. Treatment with abciximab was associated with a non-significant reduction of death and dependency combined (odds ratio (OR) 0.79; 95% confidence interval (CI) 0.54 to 1.17) and of death alone (OR 0.67; 95% CI 0.36 to 1.25). Treatment with abciximab was associated with a non-significant increase of symptomatic intracranial haemorrhages (OR 4.13; 95% CI 0.86 to 19.67) and of major extracranial haemorrhages (OR 1.51; 95% CI 0.25 to 9.12)., Authors' Conclusions: There is currently not enough evidence from randomised controlled trials regarding the efficacy or safety of GP IIb-IIIa inhibitors therapy in acute ischaemic stroke. Results from ongoing trials will help to understand the risk to benefit ratio of these agents.