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Background: Surgical site infections (SSI) are frequent complications after elective abdominal surgery. We designed the Enhanced PeriOperative Care and Health Protection programme (EPO2CH) care bundle, comprising of intraoperative high fractional inspired oxygen; intraoperative goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; glucose control and treatment of hyperglycaemia (> 10 mmol L- 1) in diabetics as well as non-diabetics; and wound irrigation before closure using an aqueous antiseptic. We hypothesise that EPO2CH added to standard care reduces the incidence of SSI compared to standard care alone for elective abdominal surgery.Methods: This trial is designed as an open label, pragmatic randomised controlled parallel-group multicentre superiority trial. The primary endpoint is the incidence of SSI, defined by the Centers for Disease Control and prevention, within 30 days after surgery. The incidence of SSI is assessed using the Dutch national complication register and medical chart review. Secondary endpoints include the SSI incidence within 90 days, incidence of anastomotic leakage at 30 and 90 days, the incidence of incisional hernia within 1 year, mortality within 1 year and 5 years, quality of life, health and disability, and cost-effectiveness. Primarily, an intention-to-treat analysis will be performed to estimate the relative risk using a log binomial model. If not feasible, a logistic regression will be used to estimate the odds ratio. A per-protocol analysis will also be performed. Furthermore, the attributive effect of the distinct interventions will be explored.Discussion: The results of the EPO2CH trial will determine if the EPO2CH bundle is effective to prevent SSI incidence for patients undergoing elective abdominal surgery. Details of the statistical analysis are described in this Statistical Analysis Plan (SAP).Trial Registration: Registration number: Dutch Trial Register Trial NL5572 . Registered on March 3, 2016. SAP version: V1.0, January 8, 2020. This SAP has been written based on study protocol V10. [ABSTRACT FROM AUTHOR]

Abstract Background To identify factors contributing to the high incidence of facility-based obstetric hemorrhage in Thyolo District, Malawi, according to local health workers. Methods Three focus group discussions among 29 health workers, including nurse-midwives and non-physician clinicians (‘medical assistants’ and ‘clinical officers’). Results Factors contributing to facility-based obstetric hemorrhage mentioned by participants were categorized into four major areas: (1) limited availability of basic supplies, (2) lack of human resources, (3) inadequate clinical skills of available health workers and (4) substandard referrals by traditional birth attendants and lack of timely self-referrals of patients. Conclusion Health workers in this district mentioned important community, system and provider related factors that need to be addressed in order to reduce the impact of obstetric hemorrhage.

Importance: Despite the absence of high-quality evidence of its safety and effectiveness, minimally invasive surgery (MIS) is increasingly used to treat advanced epithelial ovarian cancer (EOC)., Objective: To assess the feasibility of conducting a full-scale randomized clinical trial (RCT) designed to compare the efficacy of MIS vs laparotomy in patients with advanced-stage EOC and a complete or partial response to neoadjuvant chemotherapy (NACT)., Design, Setting, and Participants: This lead-in pilot phase of LANCE (Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy), an international, open-label, noninferiority RCT, opened to enrollment in September 2020 and enrolled the 100th eligible patient in February 2023. It was conducted at 11 academic cancer centers in North America and Europe. Participants were adults with stage IIIC or IV epithelial ovarian, fallopian, or primary peritoneal carcinoma who had normal cancer antigen 125 levels and at least a partial radiologic response after 3 to 4 cycles of NACT. Patients were randomly assigned to receive either interval cytoreductive surgery performed using MIS or laparotomy. Data analysis was based on the evaluable population., Interventions: The MIS arm underwent laparoscopic or robotic surgery, vs laparotomy for the control arm. Resection of all visible tumor was attempted, and conversion from MIS to laparotomy was performed when necessary to attain complete resection., Main Outcomes and Measures: Trial feasibility was defined by 3 primary end points: patient accrual rate of at least 5.6 patients per month by the last month of the lead-in pilot phase, conversion from MIS to laparotomy in less than 25% of patients, and a difference in complete gross resection rates of fewer than 20 percentage points between study arms., Results: One hundred women (median [IQR] age, 63 [39-82] years) were included, of whom 49 were randomly assigned to MIS and 51 to laparotomy; 95 were evaluable for surgical outcomes. Most patients (34 [67%] in the laparotomy arm, and 33 [67%] in the MIS arm) had stage IIIC cancer. The monthly accrual rate reached 5.9 patients per month in the final month of the study. Six of 48 evaluable patients (12.5%; 95% CI, 4.7%-25.2%) assigned to MIS underwent conversion to laparotomy. Surgeons achieved a complete gross resection rate in 42 of 48 evaluable patients (88%) assigned to MIS and in 39 of 47 patients (83%) assigned to laparotomy (difference, 4.5 [95% CI, -9.7 to 18.8] percentage points)., Conclusions and Relevance: Results of this lead-in pilot study indicated the feasibility of the LANCE RCT to compare the oncological outcomes of MIS vs laparotomy., Trial Registration: ClinicalTrials.gov Identifier: NCT04575935.

Background: In general abdominal surgery, the ratio of fat to muscle mass, or body composition measures, shows a stronger association with complications than body mass index. These studies include male and female patients. Women have a different body composition than men. Therefore, findings from general abdominal surgery cannot be extrapolated to women with cancer. The aim of this systematic review is to summarise the evidence on the association between body composition and peri- and postoperative complications in patients with gynaecological cancer., Methods: Pubmed, Embase and the Cochrane Central databases were searched in June 2023. Studies were eligible if they included patients undergoing surgery for gynaecological cancer and reported on the association between body composition (muscle or fat mass) and surgical complications. The quality of the studies was assessed using the Newcastle-Ottawa quality assessment scale. A best-evidence synthesis was used to summarise the level of evidence., Results: Fifteen studies were included that assessed muscle mass (n = 9) or fat mass (n = 6). We found strong evidence that there was no association between visceral fat and length of hospital stay. We found moderate evidence that a higher amount of good quality muscle was associated with a lower risk of postoperative complications. We found moderate evidence that there was no association between muscle or fat mass (i.e., muscle- or subcutaneous fat) and postoperative complications or fat mass and intraoperative complications. There was insufficient evidence for an association between visceral fat and intraoperative or postoperative complications, and for an association between muscle mass or -quality and length of hospital stay. There was high heterogeneity in the methods used to measure body composition, hampering meta-analyses., Conclusion: The association between body composition, particularly adipose tissue and muscle quality, and complications suggests that these measures may be of interest in determining postoperative risk in women undergoing surgery for gynaecological cancer., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To report the outcome of SLN staging in the SENTIX international prospective trial of SLN biopsy in patients with cervical cancer with an intensive ultrastaging protocol and central quality control and to evaluate how the intensity of pathological assessment correlates with metastatic detection rate in SLNs., Methods: Eligible were patients with stages T1a1/LVSI+ to T1b2 (<4 cm, ≤2 cm for fertility sparing), common tumor types, no suspicious lymph nodes on imaging, and bilateral SLN detection. SLNs were examined intraoperatively and processed by an intensive protocol for ultrastaging (paraffin blocks sectioned completely in 150-μm intervals/levels). SLNs from each site were submitted for central quality control., Results: In the SENTIX SLN study, 647 out of 733 enrolled patients underwent SLN ultrastaging, identifying 12.5% (81/647) with node positive, N1 cases. Intraoperative detection revealed metastases in 56.8% (46/81) of these cases, categorized into macrometastases (83.7%), micrometastases (26.3%), and isolated tumor cells (9.1%). Ultrastaging identified additional metastatic involvement in 43.2% (35/81) of patients, with detailed sectioning revealing metastases (MAC/MIC) at first level in 20 cases (24.7%), at levels 2-4 in 9 cases (11.1%), and at level ≥5 in 6 cases (7.4%)., Conclusion: SLN ultrastaging detects additional 43% of N1 (MAC/MIC) in patients with negative LNs by imaging and intraoperative pathological assessment. The detection rate of positive SLN correlates with the intensity (number of levels) of ultrastaging. Examination of four levels from paraffin blocks, which detects >90% of patients with N1, is a reasonable compromise for an international standard for ultrastaging., Study Registration: NCT02494063 (ClinicalTrials.gov)., Competing Interests: Declaration of competing interest The authors report no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: Cancer patients are at risk of malnutrition, which is associated with poor oncological outcomes. The aim of this study was to assess the incidence of malnutrition before, during, and after radiotherapy in locally advanced cervical cancer patients. In addition, we evaluated the impact of malnutrition on survival, and whether and when malnourished patients were referred to a dietitian., Methods: This retrospective cohort study included cervical cancer patients who received primary or adjuvant radiotherapy with curative intent between January 2013 and January 2021. Patient and treatment characteristics, including longitudinal data on weight and dietary care, were retrieved from the electronic patient files. Malnutrition was defined by body mass index and weight loss according to the Global Leadership Initiative on Malnutrition (GLIM). Overall survival was estimated using the Kaplan-Meier method. Cox proportional hazard regression analysis was used to estimate hazard ratios for key prognostic factors., Results: A total of 294 patients were included. Median follow-up was 40 months (range 7-101 months). Malnutrition occurred in 44 patients (15%) at baseline, in 132 (45%) during radiotherapy, and in 63 (21%) during follow-up. Referral to a dietician occurred in 45% of the 138 patients who were malnourished before or during radiotherapy. Malnutrition was significantly associated with worse survival after adjusting for age, performance score, diabetes, histology, International Federation of Gynecology and Obstetrics (FIGO) stage, and nodal stage. The 3 year overall survival in patients with malnutrition was 77% (95% confidence interval (CI) 70% to 85%) and without malnutrition 89% (95% CI 83% to 95%); p=0.001). Independent significant risk factors for worse overall survival were: malnutrition, age ˃52 years, adenocarcinoma, FIGO stage III/IV, and N1 disease., Conclusion: Malnutrition was common in cervical cancer patients treated with radiotherapy and was associated with a shorter overall survival. Further studies are needed to evaluate the effectiveness of better monitoring of malnutrition and faster and better dietary intervention on survival and quality of life., Competing Interests: Competing interests: BP: grant ELEKTA (payment to the institution) and payment by BD (to the institution)., (© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Continuation of smoking after a cancer diagnosis increases the burdensome side effects from cancer treatment, and decreases the chances of cure. Smoking cessation may improve oncological outcomes in cancer patients. This study aims to evaluate if radiation oncologists can be motivated by a smoking cessation awareness intervention to discuss smoking status more frequently and increase the referral rate for smoking cessation-support.Study design and Setting:A multifaceted approach was used to improve awareness: First, current practice was evaluated by a retrospective chart review of 282 patients referred for radiotherapy to ascertain smoking status, discussion of smoking cessation support and referral rates. Secondly, radiation oncologists were interviewed about their motives and barriers to discuss smoking status and smoking cessation support. The results were fed back in a teaching lecture to the doctors involved. Finally, the effect of this smoking cessation awareness intervention was prospectively evaluated in 100 patients., Results: After the smoking cessation awareness intervention, smoking cessation was more frequently discussed compared to baseline (77% (10/13)) and 39.5% (17/43) respectively. The referral rate for smoking cessation increased from 2.3% (1/43) to 69.2% (9/13)., Conclusion: Without an active smoking prevention awareness policy, referral for smoking cessation support for cancer patients by radiation oncologists is low. A relatively short and simple smoking awareness intervention for radiation oncologist may result in a more frequent discussion with patients about smoking cessation and an even larger increase in referrals for smoking cessation support., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Author(s).)

Objectives: The aim of this study was to analyze morbidity and survival after pelvic exenteration for gynecologic malignancies and evaluate prognostic factors influencing postoperative outcome., Methods: We retrospectively reviewed all patients who underwent a pelvic exenteration at the departments of gynecologic oncology of three tertiary care centers in the Netherlands, the Leiden University Medical Centre, the Amsterdam University Medical Centre, and the Netherlands Cancer Institute, during a 20-year period. We determined postoperative morbidity, 2- and 5-year overall survival (OS) and 2- and 5-year progression free survival (PFS), and investigated parameters influencing these outcomes., Results: A total of 90 patients were included. The most common primary tumor was cervical cancer (n = 39, 43.3%). We observed at least one complication in 83 patients (92%). Major complications were seen in 55 patients (61%). Irradiated patients had a higher risk of developing a major complication. Sixty-two (68.9%) required ≥1 readmission. Re-operation was required in 40 patients (44.4%). Median OS was 25 months and median PFS was 14 months. The 2-year OS rate was 51.1% and the 2-year PFS rate was 41.5%. Tumor size, resection margins and pelvic sidewall involvement had a negative impact on OS (HR = 2.159, HR = 2.376, and HR = 1.200, respectively). Positive resection margins and pelvic sidewall involvement resulted in decreased PFS (HR = 2.567 and HR = 3.969, respectively)., Conclusion: Postoperative complications after pelvic exenteration for gynecologic malignancies are common, especially in irradiated patients. In this study, a 2-year OS rate of 51.1% was observed. Positive resections margins, tumor size, and pelvic sidewall involvement were related to poor survival outcomes. Adequate selection of patients who will benefit from pelvic exenteration is important., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare and there is no financial interest to report. We certify that the submission is original work and is not under review at any other publication., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The "intermediate-risk" (IR) group of early-stage cervical cancer patients is characterized by negative pelvic lymph nodes and a combination of tumor-related prognostic risk factors such as tumor size ≥2 cm, lymphovascular space invasion (LVSI), and deep stromal invasion. However, the role of adjuvant treatment in these patients remains controversial. We investigated whether adjuvant (chemo)radiation is associated with a survival benefit after radical surgery in patients with IR cervical cancer., Methods: We analyzed data from patients with IR cervical cancer (tumor size 2-4 cm plus LVSI OR tumor size >4 cm; N0; no parametrial invasion; clear surgical margins) who underwent primary curative-intent surgery between 2007 and 2016 and were retrospectively registered in the international multicenter Surveillance in Cervical CANcer (SCCAN) study., Results: Of 692 analyzed patients, 274 (39.6%) received no adjuvant treatment (AT-) and 418 (60.4%) received radiotherapy or chemoradiotherapy (AT+). The 5-year disease-free survival (83.2% and 80.3%; P DFS = 0.365) and overall survival (88.7% and 89.0%; P OS = 0.281) were not significantly different between the AT- and AT+ groups, respectively. Adjuvant (chemo)radiotherapy was not associated with a survival benefit after adjusting for confounding factors by case-control propensity score matching or in subgroup analyses of patients with tumor size ≥4 cm and <4 cm. In univariable analysis, adjuvant (chemo)radiotherapy was not identified as a prognostic factor in any of the subgroups (full cohort: P DFS = 0.365; P OS = 0.282)., Conclusion: Among patients with IR early-stage cervical cancer, radical surgery alone achieved equal disease-free and overall survival rates to those achieved by combining radical surgery with adjuvant (chemo)radiotherapy., Competing Interests: Declaration of Competing Interest The authors declared no conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: This study examined experiences, adherence and satisfaction with a combined exercise and dietary intervention in patients with ovarian cancer and their healthcare professionals (HCPs) as part of the randomized PADOVA trial., Methods: A mixed-methods approach was used in 24 patients with ovarian cancer receiving first-line chemotherapy who were randomly allocated to a combined exercise and dietary intervention or usual care with counseling sessions post-treatment. Qualitative data on intervention experiences, adherence and satisfaction was collected using semi-structured interviews with patients and their HCPs (n = 18 physical therapists; n = 5 dietitians). Quantitative data on adherence and satisfaction was collected to provide context to qualitative data., Results: Exercise relative dose intensity ranged from 36 to 100% (median 72%) and patients attended 33-133% (median 100%) of the prescribed dietary counseling sessions. Patients appreciated guidance on exercise and nutrition and perceived benefits including improved physical fitness, quality of life, peer support and recovery after surgery and/or chemotherapy cycles. Both patients and HCPs were satisfied with the intervention and perceived that participation exceeded prior expectations. Median patient satisfaction score with the intervention was 8.5 out of 10. Suggestions for improving the intervention included further personalization of the number, content and scheduling of the sessions to preferences of patients and HCPs. Patients in the usual care group reported counseling sessions post-chemotherapy to be too little too late., Conclusions: Patients with ovarian cancer adhered well to the intervention. Numerous perceived benefits of the intervention were reported by patients and HCPs. Good adherence and positive experiences support successful implementation in clinical practice., Competing Interests: Declaration of Competing Interest The authors have no relevant financial or non-financial interests to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Adult granulosa cell tumors (AGCTs) arise from the estrogen-producing granulosa cells. Treatment of recurrence remains a clinical challenge, as systemic anti-hormonal treatment or chemotherapy is only effective in selected patients. We established a method to rapidly screen for drug responses in vitro using direct patient-derived cell lines in order to optimize treatment selection. The response to 11 monotherapies and 12 combination therapies, including chemotherapeutic, anti-hormonal, and targeted agents, were tested in 12 AGCT-patient-derived cell lines and an AGCT cell line (KGN). Drug screens were performed within 3 weeks after tissue collection by measurement of cell viability 72 h after drug application. The potential synergy of drug combinations was assessed. The human maximum drug plasma concentration (Cmax) and steady state (Css) thresholds obtained from available phase I/II clinical trials were used to predict potential toxicity in patients. Patient-derived AGCT cell lines demonstrated resistance to all monotherapies. All cell lines showed synergistic growth inhibition by combination treatment with carboplatin, paclitaxel, and alpelisib at a concentration needed to obtain 50% cell death (IC50) that are below the maximum achievable concentration in patients (IC50 < Cmax). We show that AGCT cell lines can be rapidly established and used for patient-specific in vitro drug testing, which may guide treatment decisions. Combination treatment with carboplatin, paclitaxel, and alpelisib was consistently effective in AGCT cell lines and should be further studied as a potential effective combination for AGCT treatment in patients.

Objective: Visceral obesity (VO) is a risk factor for developing postoperative complications in patients undergoing abdominal oncological surgery. However, in ovarian cancer patients this influence of body composition on postoperative morbidity is not well established. The aim of this study is to assess the association between body composition and complications in patients with advanced ovarian cancer undergoing cytoreductive surgery., Methods: Patients with FIGO stage 3 or 4 ovarian cancer between 2006 and 2017 were included. Visceral fat area, total skeletal mass and total fat area were measured on a single slice on the level of L3-L4 of the preoperative CT-scan. VO was defined as visceral fat ≥100cm 2 . The perioperative data were extracted retrospectively. A multivariate logistic regression analysis was performed to test the predictive value of multiple variables such as body composition, albumin levels and preoperative morbidity., Results: 298 consecutive patients out of nine referring hospitals were included. VO patients were more likely to be hypertensive (38% vs 17% p < 0.001), and to have an ASA 3 score (21% vs 10% P = 0.012). Complications occurred more often in VO patients (43% vs 21% P < 0.001). Thrombotic events were found in 4.9% of VO patients versus 0.6% of the non-visceral obese patients (p = 0.019). VO(OR: 4.37, p < 0.001), hypertension (OR:1.9, p = 0.046) and duration of surgery (OR: 1.004, p = 0.017) were predictors of post-surgical complications. Muscle mass is not a predictor of complications., Conclusion: Visceral obesity is associated with a higher occurrence of complications in patients with advanced ovarian cancer undergoing cytoreductive surgery., Competing Interests: Declaration of Competing Interest There are no conflicts of interest to disclose of all authors., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: SENTIX (ENGOT-CX2/CEEGOG-CX1) is an international, multicentre, prospective observational trial evaluating sentinel lymph node (SLN) biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer. We report the final preplanned analysis of the secondary end-points: SLN mapping and outcomes of intraoperative SLN pathology., Methods: Forty-seven sites (18 countries) with experience of SLN biopsy participated in SENTIX. We preregistered patients with stage IA1/lymphovascular space invasion-positive to IB2 (4 cm or smaller or 2 cm or smaller for fertility-sparing treatment) cervical cancer without suspicious lymph nodes on imaging before surgery. SLN frozen section assessment and pathological ultrastaging were mandatory. Patients were registered postoperatively if SLN were bilaterally detected in the pelvis, and frozen sections were negative., Trial Registration: ClinicalTrials.gov (NCT02494063)., Results: We analysed data for 395 preregistered patients. Bilateral detection was achieved in 91% (355/395), and it was unaffected by tumour size, tumour stage or body mass index, but it was lower in older patients, in patients who underwent open surgery, and in sites with fewer cases. No SLN were found outside the seven anatomical pelvic regions. Most SLN and positive SLN were localised below the common iliac artery bifurcation. Single positive SLN above the iliac bifurcation were found in 2% of cases. Frozen sections failed to detect 54% of positive lymph nodes (pN1), including 28% of cases with macrometastases and 90% with micrometastases., Interpretation: SLN biopsy can achieve high bilateral SLN detection in patients with tumours of 4 cm or smaller. At experienced centres, all SLN were found in the pelvis, and most were located below the iliac vessel bifurcation. SLN frozen section assessment is an unreliable tool for intraoperative triage because it only detects about half of N1 cases., Competing Interests: Conflict of interest statement The authors declare no conflict of interest., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: The efficacy of adjuvant radiotherapy in patients with intermediate risk early cervical cancer after radical hysterectomy is still under debate. Most guidelines recommend adjuvant radiotherapy, whereas others consider observation a viable option., Objective: To investigate if patients with intermediate risk factors for cervical cancer who underwent radical hysterectomy may benefit from adjuvant radiotherapy., Methods: Consecutive patients with tumor confined to the cervix and intermediate risk factors (according to Sedlis), treated between January 1982 and December 2014 who were observed after a type C2 radical hysterectomy formed the basis for this study. The frequency of recurrences, specifically isolated loco-regional recurrences, and the risk of death from recurrences, were analyzed. Data were analyzed using SPSS, version 23.0 for Windows RESULTS: A total of 161 patients were included in the analysis. Median age was 40 (range 20-76). Stages IB1 and IB2 were seen in 87 (54%) and 74 patients (46%), respectively. Squamous cell and non-squamous histology was seen in 114 (70.8%) and 47 patients (29.2%), respectively. Of the 161 patients, 25 (15.5%) had recurrent disease, of whom nine had an isolated loco-regional recurrence (5.6%). Median time to recurrence for isolated loco-regional recurrences was 28 months (range 9-151). Treatment for an isolated loco-regional recurrence was radiotherapy (n = 4) and chemoradiotherapy (n = 5). Four patients (2.5%) died from disease as a result of an isolated loco-regional recurrence. Actuarial disease- specific survival was 93.0% for the total group. No variables were found that predicted an isolated loco-regional recurrence., Discussion: The mortality from isolated loco-regional recurrence in patients with intermediate risk factors for cervical cancer who underwent only radical hysterectomy type C2 was 2.5%. Further studies should compare outcomes between patients who undergo a type C2 radical hysterectomy without adjuvant radiotherapy with those undergoing a less radical hysterectomy but with adjuvant radiotherapy., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To evaluate the frequency of and risk factors for severe late bowel toxicity after curative radiotherapy in women treated for locally advanced cervical cancer., Methods: Included were 515 women treated for locally advanced cervical cancer with primary radiotherapy with curative intent from 1992 to 2013. Bowel toxicity was graded according to the Common Terminology Criteria for Adverse Events. Associations between risk factors and severe late bowel toxicity were assessed using Cox proportional hazards regression models., Results: Median follow-up was 78months. Fifty-nine patients developed severe late bowel toxicity. The actuarial 3-year and 5-year severe late bowel toxicity rates were both 13%. In the multivariable analysis, factors significantly associated with severe late bowel toxicity were: smoking (HR 2.59 [1.48-4.55]), severe acute bowel toxicity (HR 2.46 [1.24-4.49]), previous major abdominal surgery (HR 2.35 [1.20-4.60]), hypertension (HR 2.33 [1.23-4.40]), parametrial boost (HR 2.18 [1.10-4.33]), low socioeconomic status (HR 2.05 [1.17-3.59]) and low BMI (HR 0.93 [0.88-0.99]). First symptoms of severe late bowel toxicity were reported after a median follow-up of 9months, but occurred up to 10years after end of treatment. Only one third of the patients with severe late bowel toxicity were referred to a gastroenterologist., Conclusions: Severe late bowel toxicity is a frequent complication of definitive radiotherapy for cervical cancer. Several independent risk factors were found which warrant further research. A standardized and structured approach in the early diagnostics and management of bowel toxicity is needed., (Copyright © 2017 Elsevier Inc. All rights reserved.)

To provide information on the development of a gynecologic oncology training program in a low-resource setting in Kenya. This is a review of a collaboration between Kenyan and North American physicians who worked together to develop a gynecologic oncology training in Kenya. We review the published data on the increase of cancer incidence in sub-Saharan Africa and outline the steps that were taken to develop this program. The incidence of cervical cancer in Kenya is very high and is the leading cause of cancer mortality in Kenya. WHO identifies cancer as a new epidemic affecting countries in sub-Saharan Africa. In Kenya, a country of 45 million, there is limited resources to diagnose and treat cancer. In 2009 in western Kenya, at Moi University there was no strategy to manage oncology in the Reproductive Health department. There was only 1 gynecologic oncologists in Kenya in 2009. A collaboration between Canadian and Kenya physicians resulted in development of a gynecologic oncology clinical program and initiation of fellowship training in Kenya. In the past 4 years, five fellows have graduated from a 2 year fellowship training program. Integration of data collection on all the patients as part of this program provided opportunities to do clinical research and to acquire peer reviewed grants. This is the first recognized fellowship training program in sub-Saharan Africa outside of South Africa. It is an example of a collaborative effort to improve women's health in a low-resource country. This is a Kenyan managed program through Moi University. These subspecialty trained doctors will also provide advice that will shape health care policy and provide sustainable expertise for women diagnosed with a gynecologic cancer.

Purpose: To evaluate the effectiveness and feasibility of cisplatinum for palliative treatment of advanced cervical cancer in a resource-poor setting., Methods: An observational case series is reported from a university teaching hospital in Kenya. All women presenting with advanced cervical cancer and planned for palliative cisplatinum therapy from 2010 to 2014 were included. Women were treated with cisplatinum 50 mg/m 2 every 4 weeks in an outpatient setting. Data on tumor stage and symptoms control were prospectively collected in an electronic database. The main outcome measure was control of symptoms such as bleeding, discharge, and pain., Results: Of the women who originally presented with bleeding, 62% reported improvement in this symptom, 31.3% reported the bleeding completely stopped, 58% had improvement of their vaginal discharge, and 20.5% reported complete resolution. Of the women who presented with pain, 54% reported improvement; 30.9% reported pain had completely resolved. After each treatment cycle, approximately 30% of patients did not return for their next treatment., Conclusion: Cisplatinum as palliative treatment of advanced cervical cancer is feasible in a resource-poor setting and leads to effective symptom control. However, unknown barriers may inhibit women from returning for regular treatment., Competing Interests: The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/site/ifc. Elkanah Orang'oNo relationship to disclosePeter ItsuraNo relationship to disclosePhilip TonuiNo relationship to discloseHellen MuliroNo relationship to discloseBarry RosenTravel, Accommodations, Expenses: Intuitive Surgical, da Vinci SurgeryLuc van LonkhuijzenNo relationship to disclose

Background: A maternity waiting home (MWH) is a facility within easy reach of a hospital or health centre which provides emergency obstetric care (EmOC). Women may stay in the MWH at the end of their pregnancy and await labour. Once labour starts, women move to the health facility so that labour and giving birth can be assisted by a skilled birth attendant. The aim of the MWH is to improve accessibility to skilled care and thus reduce morbidity and mortality for mother and neonate should complications arise. Some studies report a favourable effect on the outcomes for women and their newborns. Others show that utilisation is low and barriers exist. However, these data are limited in their reliability., Objectives: To assess the effects of a maternity waiting facility on maternal and perinatal health., Search Methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (27 January 2012), CENTRAL (The Cochrane Library 2011, Issue 4 of 4), MEDLINE (1966 to January 2012), EMBASE (1980 to January 2012), CINAHL (1982 to January 2012), African Journals Online (AJOL) (January 2012), POPLINE (January 2012), Dissertation Abstracts (January 2012) and reference lists of retrieved papers., Selection Criteria: Randomised controlled trials including quasi-randomised and cluster-randomised trials that compared perinatal and maternal outcome in women using a MWH and women who did not., Data Collection and Analysis: There were no randomised controlled trials or cluster-randomised trials identified from the search., Main Results: There were no randomised controlled trials or cluster-randomised trials identified from the search., Authors' Conclusions: There is insufficient evidence to determine the effectiveness of maternity waiting facilities for improving maternal and neonatal outcomes.

Objective: To identify substandard care factors in the management of obstetric hemorrhage at district hospital level in rural Malawi., Design: Retrospective hospital-based cohort study., Setting: Thyolo District Hospital., Population: Women who delivered at this facility in 2005., Methods: All cases of obstetric hemorrhage were included according to the following criteria: any antepartum hemorrhage, postpartum hemorrhage with more than 500 ml of blood loss within 24 hours after delivery, uterine rupture, retained placenta and peripartum blood transfusion., Main Outcome Measures: Incidence of antepartum and postpartum hemorrhage, related maternal and perinatal mortality and mode of delivery., Results: A total of 133 hemorrhage cases occurred among 3 085 hospital deliveries (43.1 per 1 000 deliveries), six of which resulted in maternal death (case fatality rate 4.5%). Twenty of 95 postpartum hemorrhage cases (21%) were peri-cesarean hemorrhages. Sixteen cesareans delivered lifeless fetuses, where a maternal indication for operative delivery was present in only four. Monitoring of pregnant women was regularly insufficient, including monitoring of women in waiting homes, and the use of uterotonics was often inconsistent., Conclusions: Morbidity review revealed important substandard care factors, including unnecessary cesarean sections. These factors may be modified against affordable cost, which could make an important improvement in maternal outcome., (© 2011 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2011 Nordic Federation of Societies of Obstetrics and Gynecology.)

The use of video during birth for quality of care was discussed in focus groups with women, nurses, midwives and doctors. Qualitative analysis revealed three categories of importance. First, goals and benefits: improving quality of care, teaching, research and legal issues are important potential applications. Second, limitations: concerns for privacy, fear of feedback and use of video in case of adverse events. Third, rules and regulations: goals and scope of the use of video need to be clearly described, access to video needs to be secured, and time until destruction needs to be specified. Video capture of birth is considered useful and seems acceptable if specific conditions are met., (© 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.)

Diet plays an important role in the etiology of certain cancers, but there is limited evidence with regard to the association between diet and risk of endometrial cancer. Few prospective studies have investigated meat intake as a potential determinant of endometrial cancer risk. The objective of this study was to examine the association between endometrial cancer risk and total meat, red meat, processed meat, fish, and poultry intake. We conducted a case-cohort analysis within the Canadian Study of Diet, Lifestyle, and Health, a prospective cohort of 73 909 adults (39 614 women). Participants were recruited from 1992 to 1999, predominantly from three Canadian universities. We conducted a linkage with the Ontario Cancer Registry for the years 1992-2007 for the female cohort members, who resided in Ontario at the time of enrollment (n=26 024), to yield data on cancer incidence. The analytic sample was comprised of 107 incident cases and 1830 subcohort members, the latter being an age-stratified sample of the full cohort. A nonsignificant increase in the risk of endometrial cancer was associated with increased consumption of red meat [hazard ratio (HR)=1.62, 95% confidence intervals (CI)=0.86-3.08, for high vs. low intake; P trend=0.13)], processed meat (HR=1.45, 95% CI=0.80-2.61, for high vs. low intake; P trend=0.058), and all meat combined (HR=1.50, 95% CI=0.78-2.89, for high vs. low intake; P trend=0.14). No clear patterns were noted for poultry or fish. The results of this study, although based on a limited number of cases, suggest that relatively high meat intake may be associated with increased risk of endometrial cancer.

Purpose: Worldwide, particularly in developing countries, many women present with advanced stage cervical cancer for which palliative radiotherapy is the treatment of choice or may be the only available treatment. The purpose of this study was to determine from the literature the optimal palliative radiation scheme for the treatment of advanced cervical cancer., Design: A systematic literature review up to January 2010 was performed in Medline, Embase, the Cochrane database, CinHL and Google Scholar using a combination of synonyms for: cervical cancer, palliative treatment and radiation therapy. No limitations were applied for language or study types. For included papers data were extracted and described., Results: Only eight papers were identified and none compared the results of different fractionation schemes. Most used observational retrospective study design with considerable sources of bias. No studies used validated endpoints for symptom relief nor did they include measures of the quality of life. Several papers described the experience with single or multiple monthly 10Gy doses or with a higher total dose delivered in 2-4 fractions within 48 h to 1 week. Studies report varying amounts of relief from bleeding. The effect on other symptoms such as pain and discharge is not evaluable. Acute and late toxicity is poorly documented., Conclusion: There is a dearth of information in the current literature to guide selection of an optimal palliative radiation schedule for treatment of patients with advanced cervical cancer. Based on this review and information from other solid tumors, there is no evidence to support the common belief that better and longer palliation is achieved with a high dose delivered in multiple smaller fractions. There is a clear need for comparative studies of different radiation fractionation schedules in order to identify an optimal palliative radiation scheme. These studies require the use of validated endpoints to measure specific symptom relief as well as accompanying quality of life., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Introduction: Ovarian cancer is a leading cause of cancer death for Kenyan women. Most women are diagnosed with an advanced stage of disease. The current North American standard of care includes surgery followed by carboplatin and paclitaxel. Neither drug is available for Kenyan women. We performed a literature search investigating chemotherapy in low resource countries with the aim to write an evidence-based chemotherapy protocol for women diagnosed with ovarian cancer in Eldoret, Kenya, at the Moi Teaching and Referral Hospital., Methods: We systematically searched PubMed and EMBASE for articles describing chemotherapy treatment outcomes of ovarian epithelial cancer in low-resource settings. After data analysis, a secondary review was undertaken on randomized controlled trials(RCTs) aligning with chemotherapy availability in Kenya., Results: We identified 1184 articles. Fourteen met our criteria: ovarian epithelial cancer,low resource, chemotherapy use, and survival or response data. No publications were RCTs or had a cohort larger than 100 patients. There was no consistency in drug choice between studies. After this search, we reviewed commonly quoted and relevant RCTs and meta-analyses conducted on ovarian cancer since the 1980s. Although RCTs in the developed world suggest carboplatin and taxol provide optimal survival benefit, these drugs are unavailable in Kenya. Cyclophosphamide and cisplatin provide the next most optimal survival benefit, with acceptable and manageable toxicity. Because these drugs are more available and affordable in Kenya, we have developed a protocol recommending their use, which has been accepted by the Moi Teaching and Referral Hospital., Conclusions: Currently, there is a paucity of published RCTs that may guide treatment in low-resource settings. One considerable barrier to establishing and evaluating chemotherapy protocols in low-resource settings may be the cost of chemotherapy drugs. There needs to be an international movement to make cancer chemotherapeutics available at lower prices in low-resource settings.

We evaluated the effect of so-called monitoring and treatment charts on the management of eclampsia in a referral hospital in Malawi. Baseline characteristics, clinical management, as well as overall maternal and perinatal outcome were compared by reviewing the medical files of two groups, before and after introduction of the charts in 2006. The use of the charts has resulted in improved monitoring of women with eclampsia and may have contributed to the reduction in the planned prelabour caesarean section rate from 87% to 33%, as more women underwent induction of labour after stabilisation (P = 0.020). Overall maternal and perinatal outcomes were similar., (© 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology.)

Background: Training of healthcare workers can play an important role in improving quality of care, and reducing maternal and perinatal mortality and morbidity., Objectives: To assess the effectiveness of training programmes aimed at improving emergency obstetric care in low-resource environments., Search Strategy: We searched Pubmed, Embase, Popline and selected websites, and manually searched bibliographies of selected articles. Language was not an exclusion criterion., Selection Criteria: All papers describing postgraduate training programmes aimed at improving emergency obstetric care in low-resource environments were included., Data Collection and Analysis: Two reviewers independently extracted the data and classified these according to the level of the measured effects (reaction of participants, improved knowledge and skills, changes in behaviour and outcomes in practice). Any disagreements were resolved by discussion with a third author until agreement was reached., Main Results: A total of 38 papers were selected. Training programmes vary considerably in length, content and design. The evaluation of effects is often hampered by inadequate study design and the use of non-validated measuring instruments. Most papers describe positive reactions, increased knowledge and skills, and improved behaviour after training. Outcome is assessed less frequently, and positive effects are not always demonstrated. Measures that can contribute to a positive effect of training programmes include hands-on practise, team approaches and follow-up on training efforts., Author's Conclusions: Training programmes may improve quality of care, but strong evidence is lacking. Policymakers need to include evaluation and reporting of effects in project budgets for new training programmes.

Background: A Maternity Waiting Home (MWH) is a facility, within easy reach of a hospital or health centre which provides Emergency Obstetric Care (EmOC). Women may stay in the MWH at the end of their pregnancy and await labour. Once labour starts, women move to the health facility so that labour and giving birth may be assisted by a skilled birth attendant. The aim of the MWH is to improve accessibility and thus reduce morbidity and mortality for mother and neonate should complications arise. Some studies report a favourable effect on the outcomes for women and their newborn. Others show that utilisation is low and barriers exist. However these data are limited in reliability., Objectives: To assess the effects of a maternity waiting facility on maternal and perinatal health., Search Strategy: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (April 2009), CENTRAL (The Cochrane Library 2009, Issue 1), MEDLINE (1966 to April 2009), EMBASE (1980 to April 2009), CINAHL (1982 to April 2009), African Journals Online (AJOL) (April 2009), POPLINE (April 2009), Dissertation Abstracts (April 2009) and the National Research Register archive (March 2008)., Selection Criteria: Randomised controlled trials including quasi-randomised and cluster-randomised trials that compared perinatal and maternal outcome in women using a MWH and women who did not., Data Collection and Analysis: There were no randomised controlled trials or cluster-randomised trials identified from the search., Main Results: There were no randomised controlled trials or cluster-randomised trials identified from the search., Authors' Conclusions: There is insufficient evidence to determine the effectiveness of Maternity Waiting Facilities for improving maternal and neonatal outcomes.

This study was conducted to assess the results from the use of a maternity waiting home, a health facility to which women with high risk pregnancies are referred during the last weeks of pregnancy in rural Zambia. It compared the risk status and pregnancy outcome in women staying as waiters with those women who give birth in hospital after direct admission (non-waiters). Forty seven per-cent of the non-waiters (n = 292) had no maternal risk factors and 85% had no antenatal risk factors as compared to 17% and 78% among the waiters (n = 218). Eighty six per cent of waiters had spontaneous vaginal vertex delivery as compared to 95% of non-waiters. Although the differences in risk status were statistically significant, no differences were found in birth weight and maternal and perinatal mortality. The similar obstetric outcome among waiters with more high risk pregnancies and non-waiters could be interpreted as a possible outcome of the maternity waiting home. When dependent on a proper functioning referral system, such waiting homes can reduce perinatal mortality.

Objective: To try and reduce the amount of routine postoperative radiotherapy that we prescribed without causing an unacceptable rise in locoregional recurrences., Design: Retrospective study., Setting: Teaching hospital, The Netherlands., Subjects: 836 women who were treated for breast cancer between January 1980 and December 1989., Interventions: These 836 had been treated by modified radical mastectomy (n = 534), excision of the tumour and axillary dissection (n = 279), lumpectomy (n = 15), or total mastectomy (n = 8). In December 1984 we stopped giving routine postoperative irradiation to women with T1 or T2 tumours unless there was any doubt about the operative specimen., Main Outcome Measures: The rate of locoregional recurrence 1985-9 compared with that from 1980-December 1984., Results: Only 1 patient of 836 had a clinically detectable recurrence in the internal mammary chain. There were only 2 recurrences in the 235 axillas that had not been irradiated., Conclusion: By a process of careful selection of patients for locoregional irradiation, the number of fields of irradiation given to patients with breast cancer can be reduced by up to 80% without causing a rise in the rate of locoregional recurrences.