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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.

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).)

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.

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.

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.