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Objective: To evaluate whether physical function and quality of life was influenced by discharge on the same‐day after a total laparoscopic hysterectomy. Design: Multicentre non‐inferiority randomised controlled trial. Setting: Five teaching hospitals and two university hospitals in the Netherlands. Population: Patients undergoing laparoscopic hysterectomy for benign or premalignant disease. Methods: Following informed consent, participants were allocated 1:1 either to same‐day discharge (SDD) or next‐day discharge (NDD). Main Outcome Measures: The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ‐5D‐5L). Results: Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07–0.57]). As the upper limit of the 95% CI does not exceed the non‐inferiority margin of 4 points, non‐inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found. Conclusion: This research demonstrates same‐day discharge after laparoscopic hysterectomy is non‐inferior to next day discharge in physical function 7 days after surgery. [ABSTRACT FROM AUTHOR]

Objective: To assess the influence of surgical approach, complications and patient characteristics and their postoperative functional outcomes on (sexual) quality of life (QoL) in patients with deep endometriosis (DE) with bowel involvement.Methods: Retrospective cohort study on patients surgically treated for DE in a Dutch tertiary referral hospital. Data are based on surgical records and questionnaires covering current postoperative bowel function and (sexual) QoL.Results: Postoperative functional score outcomes: constipation, fecal incontinence and Low Anterior Resection Syndrome (LARS) did not differ between patients treated with rectal shaving or segmental resection. Thirty percent of women treated with rectal shaving experienced LARS-like symptoms as well. Women who underwent segmental resection had a worse sexual QoL compared to patients managed by shaving. Patients who suffered from complications had a worse postoperative QoL. A higher postoperative constipation score was correlated with a significantly higher pain score and a lower overall and sexual QoL. LARS-score was correlated with a worsened sexual QoL.Conclusion: Women who underwent surgery for deep endometriosis rated their overall QoL as lower when a complication occurred. Segmental resection resulted in a lower sexual QoL compared to shaving. We showed that a higher LARS-score correlates with a lower sexual QOL, and postoperative constipation with more pain and a lower overall and sexual QoL. Interestingly, after using the shaving technique one-third of the patients experienced LARS-like symptoms as well. [ABSTRACT FROM AUTHOR]

Objective: To study the preferences of women with deep endometriosis (DE) with bowel involvement when they have to choose between conservative (medication) or surgical treatment. Design: Labelled discrete choice experiment (DCE). Setting: Dutch academic and non‐academic hospitals and online recruitment. Population or Sample: A total of 169 women diagnosed with DE of the bowel. Methods: Baseline characteristics and the fear of surgery were collected. Women were asked to rank attributes and choose between hypothetical conservative or surgical treatment in different choice sets (scenarios). Each choice set offered different levels of all treatment attributes. Data were analysed by using multinomial logistic regression. Main Outcome Measures: The following attributes – effect on/risk of pain, fatigue, pregnancy, endometriosis lesions, mood swings, osteoporosis, temporary stoma and permanent intestinal symptoms – were used in this DCE. Results: In the ranking, osteoporosis was ranked with low importance, whereas in the DCE, a lower chance of osteoporosis was one of the most important drivers when choosing a conservative treatment. Women with previous surgery showed less fear of surgery compared with women without surgery. Low anterior resection syndrome was almost equally important for patients as the chance of pain reduction. Pain reduction had higher importance than improving fertility chances, even in women with desire for a future child. Conclusions: The risk of developing low anterior resection syndrome as a result of treatment is almost equally important as the reduction of pain symptoms. Women with previous surgery experience less fear of surgery compared with women without a surgical history. First discrete choice experiment in patients with deep endometriosis. First discrete choice experiment in patients with deep endometriosis. [ABSTRACT FROM AUTHOR]

Objective: Endometriosis is a chronic gynaecologic disease, causing pain and infertility. As there is no definitive cure, patients are subjected to long-term care. This study aimed to improve patient-centred endometriosis care. Patient-centredness of endometriosis care can be evaluated using the validated ENDOCARE questionnaire (ECQ), resulting in centre-specific targets for improvement. To understand how to tackle the targets for improvement as found by the ECQ, focus groups can be organized. Design: This protocol presents a prospective study with a mixed-methods approach to improve patient-centredness of endometriosis care. The study consists of 5 steps: (1) evaluating current patient-centredness of endometriosis care by using the ECQ, (2) understanding targets for improvement, (3) drafting an improvement plan, (4) implementing improvements, and (5) evaluating the improved patient-centredness of endometriosis care. The final evaluation will be performed 1.5 years after implementing the improvement plan. Methods: Patient-centredness will be evaluated using the ECQ by inviting women with endometriosis to participate (steps 1 and 5). To investigate step 2, focus groups will be organized. For these focus groups, women with endometriosis are asked to participate until data saturation is achieved. During focus groups, participants are motivated to discuss the found targets for improvement and stimulated to find ways to improve them. The drafting and implementing of the improvement plan (steps 3 and 4) will be organized with the help of health-care providers in close collaboration with the patient organization. To assess whether the implementation of the improvement plan was successful in improving endometriosis care, the results from the ECQ in step 5 will be compared to the results from the ECQ in step 1. Ethical approval was granted by the local Institutional Review Board (Ref 2018.438). Setting: The study was conducted in the university hospital in the Netherlands. Limitations: Both patients and health-care providers will be involved in drafting the improvement plan. By making the health-care providers responsible for improving care, the chance of succeeding is optimized. Whether this improvement strategy is successful will be investigated after the implementation of the improvement plan. The improvement plan is clinic specific and can possibly not be extrapolated to other endometriosis clinics. In order to aim to improve patient-centred endometriosis care elsewhere, the complete study protocol should be performed. Conclusions: This study protocol aimed to investigate focus groups as a strategy to identify possible interventions to improve patient-centred endometriosis care by investigating the underlying causes for poor performance on patient-centred care. This study protocol could be used in more endometriosis care centres in the future and might also be useful for improving patient-centredness in other chronic diseases. [ABSTRACT FROM AUTHOR]

Abstract Background In the Netherlands, 30% of subfertile women are overweight or obese, and at present there is no agreement on fertility care for them. Data from observational and small intervention studies suggest that reduction of weight will increase the chances of conception, decrease pregnancy complications and improve perinatal outcome, but this has not been confirmed in randomised controlled trials. This study will assess the cost and effects of a six-months structured lifestyle program aiming at weight reduction followed by conventional fertility care (intervention group) as compared to conventional fertility care only (control group) in overweight and obese subfertile women. We hypothesize that the intervention will decrease the need for fertility treatment, diminish overweight-related pregnancy complications, and will improve perinatal outcome. Methods/Design Multicenter randomised controlled trial in subfertile women (age 18-39 year) with a body mass index between 29 and 40 kg/m2. Exclusion criteria are azoospermia, use of donor semen, severe endometriosis, premature ovarian failure, endocrinopathies or pre-existent hypertensive disorders. In the intervention group the aim is a weight loss of at least 5% to10% in a six-month period, to be achieved by the combination of a diet, increase of physical activity and behavioural modification. After six months, in case no conception has been achieved, these patients will start fertility treatment according to the Dutch fertility guidelines. In the control group treatment will be started according to Dutch fertility guidelines, independently of the patient's weight. Outcome measures and analysis The primary outcome measure is a healthy singleton born after at least 37 weeks of gestation after vaginal delivery. Secondary outcome parameters including pregnancy outcome and complications, percentage of women needing fertility treatment, clinical and ongoing pregnancy rates, body weight, quality of life and costs. Data will be analysed according to the intention to treat principle, and cost-effectiveness analysis will be performed to compare the costs and health effects in the intervention and control group. Discussion The trial will provide evidence for costs and effects of a lifestyle intervention aiming at weight reduction in overweight and obese subfertile women and will offer guidance to clinicians for the treatment of these patients. Trial registration Dutch Trial Register NTR1530

Abstract Background Multiple pregnancies are high risk pregnancies with higher chances of maternal and neonatal mortality and morbidity. In the past decades the number of multiple pregnancies has increased. This trend is partly due to the fact that women start family planning at an increased age, but also due to the increased use of ART. Couples with unexplained or mild male subfertility generally receive intrauterine insemination IUI with controlled hormonal stimulation (IUI COH). The cumulative pregnancy rate is 40%, with a 10% multiple pregnancy rate. This study aims to reveal whether alternative treatments such as IVF elective Single Embryo Transfer (IVF e SET) or Modified Natural Cycle IVF (MNC IVF) can reduce the number of multiple pregnancy rates, but uphold similar pregnancy rates as IUI COH in couples with mild male or unexplained subfertility. Secondly, the aim is to perform a cost effective analyses and assess treatment preference of these couples. Methods/Design We plan a multicentre randomised controlled clinical trial in the Netherlands comparing six cycles of intra-uterine insemination with controlled ovarian hyperstimulation or six cycles of Modified Natural Cycle (MNC) IVF or three cycles with IVF-elective Single Embryo Transfer (eSET) plus cryo-cycles within a time frame of 12 months. Couples with unexplained subfertility or mild male subfertility and a poor prognosis for treatment independent pregnancy will be included. Women with anovulatory cycles, severe endometriosis, double sided tubal pathology or serious endocrine illness will be excluded. Our primary outcome is the birth of a healthy singleton. Secondary outcomes are multiple pregnancy, treatment costs, and patient experiences in each treatment arm. The analysis will be performed according tot the intention to treat principle. We will test for non-inferiority of the three arms with respect to live birth. As we accept a 12.5% loss in pregnancy rate in one of the two IVF arms to prevent multiple pregnancies, we need 200 couples per arm (600 couples in total). Discussion Determining the safest and most cost-effective treatment will ensure optimal chances of pregnancy for subfertile couples with substantially diminished perinatal and maternal complications. Should patients find the most cost-effective treatment acceptable or even preferable, this could imply the need for a world wide shift in the primary treatment. Trial registration Current Controlled Trials ISRCTN 52843371