Search

The risk of obtaining a postsurgical infection depends highly on the air quality surrounding the exposed tissue, surgical instruments, and materials. Many isolators for open surgery have been invented to create a contained sterile volume around the exposed tissue. With the use of an isolator, a surgical procedure can be performed outside sterile environments. The goal of this study was to design an Isolator System (IS) for standard laparoscopic instruments while instrument movements are not restricted. The developed IS consists of a sleeve to protect the instrument shaft and tip and a special balloon to protect the incision and trocar tube. A coupling mechanism connected at the sleeve allows instrument changes without contamination of the isolated parts. Smoke tests were performed to show that outside air does not enter the new IS during a simulated laparoscopic procedure. Eight test runs and one baseline run inside a contained volume filled with thick smoke were performed to investigate whether smoke particles entered the Isolator System. Filters were used to identify smoke entering the Isolator System. Seven filters showed no trace of smoke particles. In one test run, a part of the IS loosened and a small brown spot was visible. The filter from the baseline run was completely covered with a thick layer of particles, proving the effectiveness of the test. During all test runs, the isolated instrument was successfully locked on and unlocked from the isolated trocar. Instrument movements gave no complications. After removal of the isolated instrument, it took three novices an average of 3.1 (standard deviation (SD), 0.7) seconds to replace it correctly on the isolated trocar. The designed IS for laparoscopy can increase sterility in environments where sterility cannot be guaranteed. The current design is developed for laparoscopy, but it can easily be adapted for other fields in minimally invasive surgery. [ABSTRACT FROM AUTHOR]

Box trainers equipped with sensors may help in acquiring objective information about a trainee's performance while performing training tasks with real instruments. The main aim of this study is to investigate the added value of force parameters with respect to commonly used motion and time parameters such as path length, motion volume, and task time. Two new dynamic bimanual positioning tasks were developed that not only requiring adequate motion control but also appropriate force control successful completion. Force and motion data for these tasks were studied for three groups of participants with different experience levels in laparoscopy (i.e., 11 novices, 19 intermediates, and 12 experts). In total, 10 of the 13 parameters showed a significant difference between groups. When the data from the significant motion, time, and force parameters are used for classification, it is possible to identify the skills level of the participants with 100% accuracy. Furthermore, the force parameters of many individuals in the intermediate group exceeded the maximum values in the novice and expert group. The relatively high forces used by the intermediates argue for the inclusion of training and assessment of force application during tissue handling in future laparoscopic skills training programs. [ABSTRACT FROM PUBLISHER]

Background: To improve endoscopic surgical skills, an increasing number of surgical residents practice on box or virtual-reality (VR) trainers. Current training is mainly focused on hand-eye coordination. Training methods that focus on applying the right amount of force are not yet available. Methods: The aim of this project is to develop a system to measure forces and torques during laparoscopic training tasks as well as the development of force parameters that assess tissue manipulation tasks. The force and torque measurement range of the developed force platform are 0-4 N and 1 Nm (torque), respectively. To show the potential of the developed force platform, a pilot study was conducted in which five surgeons experienced in intracorporeal suturing and five novices performed a suture task in a box trainer. Results: During the pilot study, the maximum and mean absolute nonzero force that the novice used were 4.7 N (SD 1.3 N) and 2.1 N (SD 0.6 N), respectively. With a maximum force of 2.6 N (SD 0.4 N) and mean nonzero force of 0.9 N (SD 0.3 N), the force exerted by the experts was significantly lower. Conclusions: The designed platform is easy to build, affordable, and accurate and sensitive enough to reflect the most important differences in, e.g., maximal force, mean force, and standard deviation. Furthermore, the compact design makes it possible to use the force platform in most box trainers. [ABSTRACT FROM AUTHOR]

In minimally invasive surgery (MIS), a surgeon needs to acquire a certain level of basic psychomotor MIS skills to perform surgery safely. Evaluation of those skills is a major impediment. Although various assessment methods have been introduced, none of them came as a superior. Three aspects of assessing psychomotor MIS skills are discussed here: (i) advantages and disadvantages of currently available assessment methods, (ii) methods to objectively classify residents according to their level of psychomotor skills, and (iii) factors that influence psychomotor MIS skills. Motion analysis has a potential to be the means to deal with assessment of psychomotor skills. Together with classification methods (e.g. linear discriminant analysis), motion analysis provides an aid in deciding whether a resident is ready to move to the next level of training. Presence of factors that influence psychomotor MIS skills results in a high need for standardisation of valid tasks and setups used for the assessment of MIS skills. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To evaluate and update the current status of the implementation of operative laparoscopy in gynaecology in The Netherlands by assessing diffusion and acceptance of each specific procedure per hospital. Study design: In 2003 a questionnaire was sent to all hospitals (n =102), which addressed the total number and type of laparoscopic procedures performed in 2002 stratified by level of difficulty (level 1: diagnostic laparoscopy, sterilization, tubal patency tests; level 2: adhesiolysis, ectopic pregnancy (EP), laparoscopic treatment of endometriosis, cystectomy, oophorectomy, LAVH, tubal surgery for infertility; level 3: myomectomy, total laparoscopic hysterectomy (TLH) and sacropexy). Data were compared to previously published data of 1994. Results: Response rate was 79% (81/102). Diffusion and acceptance of level 2 procedures increased significantly, except endometriosis and tubal surgery for infertility. Diffusion of LAVH was only 58%. Four percent of hysterectomies were LAVH. TLH and sacropexy were not performed. The diffusion of myomectomy increased significantly (p =0.01), whereas its acceptance remained low. Conclusions: Although the diffusion of operative procedures has increased over the last decade, acceptance is still limited, especially for laparoscopic hysterectomy. The implementation of operative gynaecological laparoscopy in The Netherlands seems to develop at a slow pace. [Copyright &y& Elsevier]

Objective: To estimate the risk of uterine leiomyosarcoma in patients undergoing gynecological surgery and also to identify groups at risk for unrecognized uterine leiomyosarcoma.Methods: A national cohort study was performed evaluating all uterine leiomyosarcoma (ULMS) diagnosed in The Netherlands between January 2000 and September 2015. Cases were identified and supplied by the nationwide network and registry of histo- and cytopathology in The Netherlands (PALGA). Unexpected and expected ULMS were compared. Approval for this study was granted by the Medical Ethics Committee of all participating hospitals and by the review board of PALGA.Results: 262 original cases were included. The overall incidence of ULMS in our study was 0.25% or 1:400 patients. The incidence of unexpected ULMS was 0.12% or 1:865 patients. Preoperatively, a malignancy was unexpected in 46% of the cases and expected in 54%. Abnormal uterine bleeding constituted most of the symptoms. 90% of women underwent abdominal hysterectomy and/or bilateral salpingo-oophorectomy.Conclusions: Leiomyosarcoma are rare. Women aged 40-50 years with abnormal uterine bleeding are most at risk for unexpected ULMS. In contrast, this risk is low in postmenopausal women. ULMS were highly uncommon in women aged under 40 years. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the catheterisation regimes after a laparoscopic hysterectomy (LH) in Dutch hospitals and to assess the nurses' opinion on this topic. This was particularly relevant as no consensus exists on the best moment to remove a urinary catheter after an LH. All 89 Dutch hospitals were successfully contacted and provided information on their catheterisation regime after LH: 69 (77.5%) hospitals reported removing the catheter the next morning after the LH, while nine hospitals (10.1%) removed it directly at the end of the procedure. The other 11 hospitals had different policies (four hours, up to two days). Additionally, all nurses working in the gynaecology departments of the hospitals affiliated to Leiden University were asked to fill in a self-developed questionnaire. Of the 111 nurses who completed the questionnaire (response rate 81%), 90% was convinced that a direct removal was feasible and 78% would recommend it to a family member or friend. Impact Statement What is already known on this subject? Although an indwelling catheter is routinely placed during a hysterectomy, it is unclear what the best moment is to remove it after an LH specifically. To fully benefit from the advantages associated with this minimally invasive approach, postoperative catheter management, should be, amongst others, optimal and LH-specific. A few studies have demonstrated that the direct removal of urinary catheter after an uncomplicated LH is feasible, but the evidence is limited. What the results of this study add? While waiting for the results of the randomised trials, this present study provides insight into the nationwide catheterisation management after an LH. Despite the lack of consensus on the topic, catheterisation management was quite uniform in the Netherlands: most Dutch hospitals removed the urinary catheter one day after an LH. Yet, this was not in line with the opinion of the surveyed nurses, as the majority would recommend a direct removal. This is interesting as nurses are closely involved in the patients' postoperative care. What are the implications of these findings for clinical practice and/or further research? Although randomised trials are necessary to determine an optimal catheterisation management, the findings of this present study are valuable if a new urinary catheter regime has to be implemented. [ABSTRACT FROM AUTHOR]

Background: To assess potential risks of new surgical procedures and devices before their introduction into daily practice, a prospective risk inventory (PRI) is a required step. This study assesses the applicability of the Health Failure Mode and Effects Analysis (HFMEA) as part of a PRI of new technology in minimally invasive gynecologic surgery.Methods: A reference case was defined of a patient with presumed benign leiomyoma undergoing a laparoscopic hysterectomy or myomectomy including in-bag power morcellation; however, pathology defined a stage I uterine leiomyosarcoma. Using in-bag morcellation as a template, a HFMEA was performed. All steps of the in-bag morcellation technique were identified. Next, the possible hazards of these steps were explored and possible measures to control these hazards were discussed.Results: Five main steps of the morcellation process were identified. For retrieval bags without openings to accommodate instruments inside the bag, 120 risks were identified. Of these risks, 67 should be eliminated. For containment bags with openings 131 risks were identified of which 68 should be eliminated. Of the 10 causes most at risk to cause spillage, two can be eliminated by using appropriate bag materials. Myomectomy appears to be more at risk for residual tissue spillage compared to total hysterectomy.Conclusion: The HFMEA has provided important new insights regarding potential weaknesses of the in-bag morcellation technique, particularly with respect to hazardous steps in the morcellation process as well as requirements that bags should meet. As such, this study has shown HFMEA to be a valuable method that identifies and quantifies potential hazards of new technology. [ABSTRACT FROM AUTHOR]

Background: The success of newly introduced surgical techniques is generally primarily assessed by surgical outcome measures. However, data on medical liability should concomitantly be used to evaluate provided care as they give a unique insight into substandard care from patient's point of view. The aim of this study was to analyze the number and type of medical claims after laparoscopic gynecologic procedures since the introduction of advanced laparoscopy two decades ago. Secondly, our objective was to identify trends and/or risk factors associated with these claims.Methods: To identify the claims, we searched the databases of the two largest medical liability mutual insurance companies in The Netherlands (MediRisk and Centramed), covering together 96% of the Dutch hospitals. All claims related to laparoscopic gynecologic surgery and filed between 1993 and 2015 were included.Results: A total of 133 claims met our inclusion criteria, of which 54 were accepted claims (41%) and 79 rejected (59%). The number of claims remained relatively constant over time. The majority of claims were filed for visceral and/or vascular injuries (82%), specifically to the bowel (40%) and ureters (20%). More than one-third of the injuries were entry related (38%) and 77% of the claims were filed after non-advanced procedures. A delay in diagnosing injuries was the primary reason for financial compensation (33%). The median sum paid to patients was €12,000 (500-848,689). In 90 claims, an attorney was defending the patient (83% for the accepted claims; 57% for the rejected claims).Conclusion: The number of claims remained relatively constant during the study period. Most claims were provoked by bowel and ureter injuries. Delay in recognizing injuries was the most encountered reason for granting financial compensation. Entering the abdominal cavity during laparoscopy continues to be a potential dangerous step. As a result, gynecologists are recommended to thoroughly counsel patients undergoing any laparoscopic procedure, even regarding the risk of entry-related injuries. [ABSTRACT FROM AUTHOR]

Background: New technology should be extensively tested before it is tried on patients. Unfortunately representative models are lacking. In theory, fresh frozen human cadavers are excellent models.Objective: To identify strengths and weaknesses of fresh frozen human cadavers as research models for new technology prior to implementation in gynecological surgery.Methods: During pre-clinical validation studies regarding the MobiSep uterine manipulator, test procedures were performed on fresh frozen cadavers. Both the experimental setup as the performance of the prototype were assessed.Results: Five tests including six human cadavers were performed. Major changes were made to the MobiSep prototype design. The cadavers of two tests closely resembled surgical experiences as found in live patients. The anatomy of 4 of the 6 cadavers was not fully representative due to atrophy of the internal genitalia caused by age and due to the presence of pathology such extensive tumorous tissue.Conclusion: The cadaver tests provided vital information regarding design and functionality, that failed to emerge during the in-vitro testing. However, experiments are subject to anatomical uncertainties or restrictions. Consequently, the suitability of a cadaver should be carefully assessed before it is used for testing new technology. [ABSTRACT FROM AUTHOR]

Background: Since the introduction of minimally invasive surgery (MIS), concerns for patient safety are more often brought to the attention. Knowledge about and awareness of patient safety risk factors are crucial in order to improve and enhance the surgical team, the environment, and finally surgical performance. The aim of this study was to identify and quantify patient safety risk factors in laparoscopic hysterectomy and to determine their influence on surgical outcomes.Methods: A prospective multicenter study was conducted from April 2014 to January 2016, participating gynecologists registered their performed laparoscopic hysterectomies (LHs). If deemed necessary, gynecologists could fill out a checklist with validated patient safety risk factors. Association between procedures with and without an occurred risk factor(s) and the surgical outcomes (blood loss, operative time, and complications) were assessed, using multivariate logistic regression and generalized estimation equations.Results: Eighty-five gynecologists participated in the study, registering a total of 2237 LHs. For 627(28 %) procedures, the checklist was entered (in total 920 items). The most reported risk factors were related to the surgeon (19.6 %), the surgical team (14.4 %), technology (16.6 %), and the patient (26.8 %). The procedures where a risk factor was registered had significantly less favorable outcomes, higher complication rate (10.5 vs. 4.8 % (p = 0.002), longer operative time [114 vs. 95 min (p < 0.001)], and more blood loss [110 vs. 168 mL (p = 0.047)], which was mainly due to the technological and patient-related risk factors.Conclusion: Technological incidents are the most important and clinically relevant risk factors affecting surgical outcomes of LH. Future improvements of MIS need to focus on this. As awareness of safety risk factors in MIS is important, embedding of a safety risk factor checklist in registration systems will help surgeons to evaluate and improve their individual performance. This will inherently improve the surgical outcomes and thus patient safety. [ABSTRACT FROM AUTHOR]

Purpose: To assess the safety and effectiveness of LESS compared to conventional hysterectomy.Methods: The systematic review and meta-analysis was performed according to the MOOSE guideline, and quality of evidence was assessed using GRADE. Different databases were searched up to 4th of August 2016. Randomized controlled trials and cohort studies comparing LESS to the conventional laparoscopic hysterectomy were considered for inclusion.Results: Of the 668 unique articles, 23 were found relevant. We investigated safety by analyzing the complication rate and found no significant differences between both groups [OR 0.94 (0.61, 1.44), I 2 = 19%]. We assessed effectiveness by analyzing conversion risk, postoperative pain, and patient satisfaction. For conversion rates to laparotomy, no differences were identified [OR 1.60 (0.40, 6.38), I 2 = 45%]. In 3.5% of the cases in the LESS group, an additional port was needed during LESS. For postoperative pain scores and patient satisfaction, some of the included studies reported favorable results for LESS, but the clinical relevance was non-significant. Concerning secondary outcomes, only a difference in operative time was found in favor of the conventional group [MD 11.3 min (5.45-17.17), I 2 = 89%]. The quality of evidence for our primary outcomes was low or very low due to the study designs and lack of power for the specified outcomes. Therefore, caution is urged when interpreting the results.Conclusion: The single-port technique for benign hysterectomy is feasible, safe, and equally effective compared to the conventional technique. No clinically relevant advantages were identified, and as no data on cost effectiveness are available, there are currently not enough valid arguments to broadly implement LESS for hysterectomy. [ABSTRACT FROM AUTHOR]

Purpose: To compare hospital versus individual surgeon's perioperative outcomes for laparoscopic hysterectomy (LH), and to assess the relationship between surgeon experience and perioperative outcomes.Methods: A retrospective analysis of all prospective collected LHs performed from 2003 to 2010 at one medical center was performed. Perioperative outcomes (operative time, blood loss, complication rate) were assessed on both a hospital level and surgeon level using Cumulative Observed minus Expected performance graphs.Results: A total of 1618 LHs were performed, 16 % total laparoscopic hysterectomies and 84 % laparoscopic supracervical hysterectomies. Overall outcomes included mean (SD±) blood loss 108.9 ± 69.2 mL, mean operative time 95.4 ± 39.7 min and a complication occurred in 76 (4.7 %) of cases. Suboptimal perioperative outcomes of an individual surgeon were not always detected on a hospital level. However, collective suboptimal outcomes were faster detected on a hospital level compared to individual surgeon's level. Evidence of a learning curve is seen; for the first 100 procedures, a decrease in operative time is observed as individual surgeon experience increases. Similarly, the risk of conversion decreases up to the first 50 procedures.Conclusion: An individual outlier (i.e., surgeon with consistently suboptimal performance) will not always be detected when monitoring outcome measures only on a hospital level. However, monitoring outcome measures on a hospital level will detect suboptimal performance earlier compared to monitoring only on an individual surgeon's level. To detect performance outliers timely, insight into an individual surgeon's outcome and skills is recommended. Furthermore, an experienced surgeon is no guarantee for acceptable surgical outcomes. [ABSTRACT FROM AUTHOR]

Background: Minimally invasive surgery (MIS) is frequently compromised by surgical flow disturbances due to technology- and equipment-related failures. Compared with MIS in a conventional cart-based OR, performing MIS in a dedicated integrated operating room (OR) is supposed to be beneficial to patient safety. The aim of this study was to compare a conventional OR with an integrated OR with regard to the incidence and effect of equipment-related surgical flow disturbances during an advanced laparoscopic gynecological procedure [laparoscopic hysterectomy (LH)].Methods: Using video recording, 40 LHs performed between November 2010 and April 2012 (20 in a conventional cart-based OR and 20 in an integrated OR) were analyzed by two different observers. Outcome measures were the number, duration and effect (on a seven-point ordinal scale) of the surgical flow disturbances (e.g., malfunctioning, intraoperative repositioning, setup device).Results: A total of 103 h and 45 min was observed. The interobserver agreement was high (kappa .85, p < .001). Procedure time was not significantly different (NS) [conventional OR vs. integrated OR, minutes ± standard deviation (SD), mean 161 ± 27 vs. 150 ± 34]. A total of 1651 surgical flow disturbances were observed (mean ± SD per procedure 40.8 ± 19.4 vs. 41.8 ± 15.9, NS). The mean number of surgical flow disturbances per procedure with regard to equipment was 6.3 ± 3.7 versus 8.5 ± 4.0, NS. No clinically relevant differences in the mean effect of these disturbances on the surgical flow between the two OR setups were observed.Conclusions: Performing LH in an integrated OR did not reduce the number of surgical flow disturbances nor the effect of these disturbances. Furthermore, in the integrated OR, repositioning of the monitors was a frequent and time-consuming source of disturbance. In order to maintain the high standard of surgical safety, the entire surgical team has to be aware that by performing surgery in an integrated OR different potential source for disruption arise. [ABSTRACT FROM AUTHOR]

Background: Currently, task time and errors are often used as performance parameters in laparoscopic training. Training with the focus on task time improvement alone results in fast, but possibly less controlled, instrument movements and therefore suboptimal tissue handling skills. Methods: Twenty-five medical students were randomly assigned in two groups. Both groups performed a tissue manipulation task six times. During this training session, the time feedback group ( n = 13) received real-time visual feedback of the task time. The force feedback group ( n = 12) received real-time visual feedback of the tissue manipulation force. After the training sessions, participants in both groups performed an entirely different task without visual feedback. Task time, force, and motion parameters of this posttest were used to compare the technical skills of the medical students. Results: The training data of the group that received force feedback showed a learning curve for the mean and max absolute force, max force area, force volume, task time, and path length of both instruments. The data from the group that received time feedback showed a learning curve for the max force, task time, and path length of both instruments. In the posttest, the parameters of mean absolute force ( p = 0.039), max force ( p = 0.041), and force volume ( p = 0.009) showed a significant difference in favor of the group that received force feedback. Conclusions: The learning curves and the posttest indicate that training with visual force feedback improves tissue handling skills with no negative effect on the task time and instrument motions. Conventional laparoscopic training with visual time feedback improves instrument motion and task time, but it does not improve tissue manipulation skills. [ABSTRACT FROM AUTHOR]

Background: In laparoscopic surgery, conversion to laparotomy is associated with worse clinical outcomes, especially if the conversion is due to a complication. Although apparently important, no commonly used definition of conversion exists. The aim of this study was to achieve multidisciplinary consensus on a uniform definition of conversion. Methods: On the basis of definitions currently used in the literature, a web-based Delphi consensus study was conducted among members of all four Dutch endoscopic societies. The rate of agreement (RoA) was calculated; a RoA of >70 % suggested consensus. Results: The survey was completed by 268 respondents in the first Delphi round (response rate, 45.6 %); 43 % were general surgeons, 49 % gynecologists, and 8 % urologists. Average ± standard deviation laparoscopic experience was 12.5 ± 7.2 years. On the basis of the results of round 1, a consensus definition was compiled. Conversion to laparotomy is an intraoperative switch from a laparoscopic to an open abdominal approach that meets the criteria of one of the two subtypes: strategic conversion, a standard laparotomy that is made directly after the assessment of the feasibility of completing the procedure laparoscopically and because of anticipated operative difficulty or logistic considerations; and reactive conversion, the need for a laparotomy because of a complication or (extension of an incision) because of (anticipated) operative difficulty after a considerable amount of dissection (i.e., >15 min in time). A laparotomy after a diagnostic laparoscopy (i.e., to assess the curability of the disease) should not be considered a conversion. In the second Delphi round, a RoA of 90 % was achieved with this definition. Conclusions: After two Delphi rounds, consensus on a uniform multidisciplinary definition of conversion was achieved within a representative group of general surgeons, gynecologists, and urologists. An unambiguous interpretation will result in a more reliable clinical registration of conversion and scientific evaluation of the feasibility of a laparoscopic procedure. [ABSTRACT FROM AUTHOR]

Background: To improve endoscopic surgical skills, an increasing number of surgical residents practice on box or virtual reality (VR) trainers. Current training is focused mainly on hand-eye coordination. Training methods that focus on applying the right amount of force are not yet available. Methods: The aim of this project is to develop a low-cost training system that measures the interaction force between tissue and instruments and displays a visual representation of the applied forces inside the camera image. This visual representation continuously informs the subject about the magnitude and the direction of applied forces. To show the potential of the developed training system, a pilot study was conducted in which six novices performed a needle-driving task in a box trainer with visual feedback of the force, and six novices performed the same task without visual feedback of the force. All subjects performed the training task five times and were subsequently tested in a post-test without visual feedback. Results: The subjects who received visual feedback during training exerted on average 1.3 N (STD 0.6 N) to drive the needle through the tissue during the post-test. This value was considerably higher for the group that received no feedback (2.6 N, STD 0.9 N). The maximum interaction force during the post-test was noticeably lower for the feedback group (4.1 N, STD 1.1 N) compared with that of the control group (8.0 N, STD 3.3 N). Conclusions: The force-sensing training system provides us with the unique possibility to objectively assess tissue-handling skills in a laboratory setting. The real-time visualization of applied forces during training may facilitate acquisition of tissue-handling skills in complex laparoscopic tasks and could stimulate proficiency gain curves of trainees. However, larger randomized trials that also include other tasks are necessary to determine whether training with visual feedback about forces reduces the interaction force during laparoscopic surgery. [ABSTRACT FROM AUTHOR]

Objective: To identify predictors of postsurgical adhesion formation in peritoneal fluid and plasma, and assess efficacy and safety of reteplase (recombinant plasminogen activator [r-PA]). Design: Prospective randomized study. Setting: University Medical Center. Patient(s): Twenty-six abdominal myomectomy patients with early second-look laparoscopy (ESL). Intervention(s): Randomization to IP treatment with 1 mg reteplase in 300 mL Ringer''s lactate or 300 mL Ringer''s lactate only. Scoring of adhesions and collecting peritoneal fluid during both surgical procedures and collecting plasma samples at ten time points. Main Outcome Measure(s): Incidence, severity, and extent of adhesions at ESL. Concentrations of C-reactive protein (CRP), tissue-type plasminogen activator (tPA), plasminogen activator inhibitor 1 (PAI-1), and fibrin degradation products (FbDPs). Result(s): Significant correlation between the extent of uterine adhesion formation and preoperative plasma levels of CRP (rs = 0.558), PAI-1 (rs = 0.413), and the change in tPA concentration in peritoneal fluid from initial surgery to ESL (Δ+PA: rs = −0.636). No significant differences in adhesion scores between treatment and control groups. Conclusion(s): Our finding that preoperative plasma CRP and PAI-1-levels are significantly correlated with extent of adhesion formation points to a role of chronic inflammation in the disease process. Results are highly indicative for the paradigm that adhesions are caused by an insufficiency in peritoneal fibrinolytic capacity. For successful adhesion prevention therapy relatively high amounts of r-PA are required. [Copyright &y& Elsevier]

Not much is known about the exact role of force feedback in laparoscopy. This study aimed to determine whether force feedback influences movements of instruments during training in laparoscopic tasks and whether force feedback is required for training in basic laparoscopic force application tasks. A group of 19 gynecologic residents, randomly divided into two groups, performed three laparoscopic tasks in both the box trainer and the virtual reality (VR) trainer. The box-VR group began with the box trainer, whereas the VR-box group began with the VR trainer. The three selected tasks included different levels of force application. The box trainer provides natural force feedback, whereas the VR trainer does not provide force feedback. The performance of the two groups was compared with regard to time, path length, and depth perception. For the tasks in which force plays hardly a role, no differences between box-VR group and the VR-box group were found. During a task in which force application (pulling and pushing forces) plays a role, the box-VR group outperformed VR-box group in the box trainer. Moreover, training with the box trainer had a positive effect on subsequent performance of the task with the VR trainer. This was not found the other way around. No differences were found between box-VR and the VR-box group in tasks not requiring force application. Force feedback influences basic laparoscopic skills during tasks in which pulling and pushing forces are applied. For these tasks, the switch from the trainer without force feedback to the one with natural force feedback has a detrimental effect on performance. Therefore, training for tasks in which forces play an important role (e.g., stretching, grasping) should be done using systems with natural force feedback, whereas eye–hand coordination can be trained without force feedback. [ABSTRACT FROM AUTHOR]

Background: Installation of the pneumoperitoneum is an essential part of laparoscopic surgery. Creation can be performed by either the open or a closed technique. The aim of this study was to assess the number of and contributing factors to entry-related complications in medical liability insurance claims in The Netherlands.Methods: A retrospective chart review was performed, including all malpractice claims filed at MediRisk, which is presently the largest medical liability mutual insurance company for institutions, mainly hospitals, in healthcare in The Netherlands.Results: From January 1993 to December 2005, 41 claims were identified as entry-related complications which comprised 18% of all laparoscopy-related complications leading to claims. Most were young (median age = 35 years) female patients who had routine, nonadvanced, laparoscopic procedures planned as short-stay or day-care procedures. The claims were equally divided between general surgery (n = 20) and gynecology (n = 21). A total of 51 structures were injured. There were 18 vascular structure injuries, 30 bowel injuries, and three other injuries. An open entry technique was used in only two (5%) patients. Vascular injury was exclusively associated with closed entry. In only 19 (46%) patients the entry-related complication was diagnosed peroperatively, consisting of 70% of the vascular and 25% of the bowel injuries. Twenty-six patients (64%) were admitted to the intensive care unit for a median of five days. There was no mortality. Besides conversion, the majority of the patients filed a claim to compensate for a longer hospital stay and related costs. A payment was made in 17 (57%) of the 30 settled claims.Conclusions: Medical liability claims concerning laparoscopic entry-related complications comprised a fifth of all laparoscopy-related claims. Claims concerning entry-related complications occurred in young patients who had routine, nonadvanced procedures. In the investigated cases most claims involved the closed-entry technique. [ABSTRACT FROM AUTHOR]

Background: To evaluate the effect of a mentor traineeship in laparoscopic surgery in a teaching hospital. Method: This observational study was performed between January 1997 and December 2004 at Bronovo Hospital, The Hague, The Netherlands. Since January 2001, an advanced endoscopic gynecologist has mentored a trainee in laparoscopic surgery. Data on the trainee’s procedures preceding (1997–2000) and during the mentor traineeship (2001–2004) were compared. The number and type of procedures performed, complications and conversions were derived from a prospectively kept database supplemented by a retrospective chart review. Operating times for total laparoscopic hysterectomy (TLH) were registered to establish the trainee’s learning curve. Results: Since the presence of a mentor, the trainee has performed significantly more advanced laparoscopic procedures. Despite the significant increase in advanced cases, the trainee’s laparoscopic conversion rate to laparotomy remained stable between period 1 and period 2 (7.5 and 4.5%, respectively, p = 0.35, 95% CI –0.033 to 0.092); moreover, for level-3 procedures the conversion rate decreased (p < 0.001, 95% CI 0.30–0.71). Despite the increase in advanced cases, the total complication rate remained stable (3.2–4.5%, p = 0.62, 95% CI –0.07 to 0.04) including the number of level-3 complications (p = 0.63, 95% CI –0.4 to 0.3). A decreasing trend in operating time for TLH was found; however, this was not significant (Spearman correlation coefficient –0.421, p = 0.81). Conclusions: Mentor traineeship in gynecology enhanced the advanced laparoscopic caseload. With the increase in advanced procedures, no increase in conversion rate, complication rate or operating times for TLH was found. Due to the mentorship, patients were not exposed to increased complications and conversions, or to the disadvantages of a prolonged operating time. Predominantly, mentor traineeship facilitated the implementation of laparoscopic surgery into an established gynecological practice in a teaching hospital. Copyright © 2007 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]