Treatment preferences for medication or surgery in patients with deep endometriosis and bowel involvement: a discrete choice experiment

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. Tweetable Abstract First discrete choice experiment in patients with deep endometriosis.Gynecolog

SOMA-trial: surgery or medication for women with an endometrioma? Study protocol for a randomised controlled trial and cohort study

STUDY QUESTIONS:The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones). The primary outcome is defined as successful pain reduction (-30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact. WHAT IS KNOWN ALREADY:Evidence suggests that both medication and surgical treatment of an ovarian endometrioma are effective in reducing pain and improving quality of life. However, there are no randomised studies that compare surgery to treatment with medication. STUDY DESIGN SIZE DURATION:This study will be performed in a research network of university and teaching hospitals in the Netherlands. A multicentre randomised controlled trial and parallel prospective cohort study in patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted. After obtaining informed consent, eligible patients will be randomly allocated to either treatment arm (medication or surgery) by using web-based block randomisation stratified per centre. A successful pain reduction is set at a 30% decrease on the NRS at 6 months after randomisation. Based on a power of 80% and an alpha of 5% and using a continuity correction, a sample size of 69 patients in each treatment arm is needed. Accounting for a drop-out rate of 25% (i.e. loss to follow up), we need to include 92 patients in each treatment arm, i.e. 184 in total. Simultaneously, a cohort study will be performed for eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms. We intend to include 100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total. The expected inclusion period is 24 months with a follow-up of 18 months. PARTICIPANTS/MATERIALS SETTING METHODS:Premenopausal women (age ≥ 18 years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma (cyst diameter ≥ 3 cm) who visit the outpatient clinic will make up the study population. Patients with signs of deep endometriosis will be excluded. The primary outcome is successful pain reduction, which is defined as a 30% decrease of pain on the NRS at 6 months after randomisation. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas. Measurements will be performed at baseline, 6 weeks and 6, 12 and 18 months after randomisation. STUDY FUNDING/COMPETING INTERESTS:This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-85200-98-91041. The Department of Reproductive Medicine of the Amsterdam UMC location VUmc has received several research and educational grants from Guerbet, Merck KGaA and Ferring not related to the submitted work. B.W.J. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck KGaA and Guerbet. V. Mijatovic reports grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication. TRIAL REGISTRATION NUMBER:Dutch Trial Register (NTR 7447, http://www.trialregister.nl). TRIAL REGISTRATION DATE:2 January 2019. DATE OF FIRST PATIENT’S ENROLMENT:First inclusion in randomised controlled trial October 4, 2019. First inclusion in cohort May 22, 2019.E. van Barneveld, V.B.Veth, J.M. Sampat, A.M.F. Schreurs, M. vanWely, J.E. Bosmans ... et al

Endometrial scratching in women with one failed IVF/ICSI cycle-outcomes of a randomised controlled trial (SCRaTCH)

STUDY QUESTION: Does endometrial scratching in women with one failed IVF/ICSI treatment affect the chance of a live birth of the subsequent fresh IVF/ICSI cycle? SUMMARY ANSWER: In this study, 4.6% more live births were observed in the scratch group, with a likely certainty range between -0.7% and +9.9%. WHAT IS KNOWN ALREADY: Since the first suggestion that endometrial scratching might improve embryo implantation during IVF/ICSI, many clinical trials have been conducted. However, due to limitations in sample size and study quality, it remains unclear whether endometrial scratching improves IVF/ICSI outcomes. STUDY DESIGN, SIZE, DURATION: The SCRaTCH trial was a non-blinded randomised controlled trial in women with one unsuccessful IVF/ICSI cycle and assessed whether a single endometrial scratch using an endometrial biopsy catheter would lead to a higher live birth rate after the subsequent IVF/ICSI treatment compared to no scratch. The study took place in 8 academic and 24 general hospitals. Participants were randomised between January 2016 and July 2018 by a web-based randomisation programme. Secondary outcomes included cumulative 12-month ongoing pregnancy leading to live birth rate. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with one previous failed IVF/ICSI treatment and planning a second fresh IVF/ICSI treatment were eligible. In total, 933 participants out of 1065 eligibles were included (participation rate 88%). MAIN RESULTS AND THE ROLE OF CHANCE: After the fresh transfer, 4.6% more live births were observed in the scratch compared to control group (110/465 versus 88/461, respectively, risk ratio (RR) 1.24 [95% CI 0.96-1.59]). These data are consistent with a true difference of between -0.7% and +9.9% (95% CI), indicating that while the largest proportion of the 95% CI is positive, scratchin

Immediate catheter removal after laparoscopic hysterectomy: A retrospective analysis

Objectives: All patients undergoing a laparoscopic hysterectomy receive an indwelling catheter during surgery. The optimum timing of removal of the catheter is uncertain. A possible advantage of leaving the catheter in up to 12 h after surgery is to reduce the risk of urinary retention. Possible disadvantages are patient discomfort and increased risk of urinary tract infection. Timing of removal of the catheter after laparoscopic hysterectomy has not been studied. Previous studies have assessed timing of catheter removal after abdominal hysterectomy. In these studies immediate removal seems safe and feasible after an uncomplicated hysterectomy. In 2015 immediate catheter removal after an uncomplicated hysterectomy was introduced in our clinic. We performed a retrospective analysis of all patients who underwent a laparoscopic hysterectomy. The primary objective of this study was to evaluate the rate of urinary retentions and the secondary objective was to investigate the rate of urinary tract infections when the indwelling catheter was removed immediate after surgery.Study design: We included all women who underwent a laparoscopic hysterectomy from April 2015 until December 2017. Informed consent was obtained from all patients. Medical records were analysed to identify baseline characteristics, surgical details and complications. General practitioners of the included patients were contacted to check for post-operative urinary tract infection up to 6 weeks after surgery.Results: 325 patients underwent an uncomplicated hysterectomy between April 2015 and December 2017. After informed consent we ultimately included 242 cases in our analysis. The mean age of our study population was 50 years. In 194 (802 %) patients the catheter was removed immediately after surgery. Main reason for delayed removal of the catheter was resection of deep endometriosis (n = 21). The incidence of urinary retention was 4,6 % (95 % CI 2,3-8,3 %) in the immediate removal group. In these 9 cases, 5 (2,6 %) where solved after single catheterisation. The remaining 4 patients (2,0 %) had an indwelling catheter for 24 h after which the urinary retention resolved. The incidence of urinary tract infection was 9,3 % (95 % CI 5,8-14,0- %), when the catheter was removed immediately after surgery. The incidence of urinary retention and UTI were respectively 2,1% (95 % CI 0,1-9,8%) and 208 % (95 % CI 11,1-34,0 %) in the cases with delayed catheter removal (N = 48).Conclusion: Immediate removal of the urine catheter after uncomplicated hysterectomy is safe and results in low levels of urinary retention. (C) 2020 Published by Elsevier B.V

Productivity loss due to menstruation-related symptoms: a nationwide cross-sectional survey among 32 748 women

Contains fulltext : 205355.pdf (publisher's version ) (Open Access)OBJECTIVE: To evaluate age-dependent productivity loss caused by menstruation-related symptoms, measured in absenteeism (time away from work or school) and presenteeism (productivity loss while present at work or school). METHODS: Design/setting: internet-based, cross-sectional survey conducted in the Netherlands from July to October 2017. PARTICIPANTS: 32 748 women aged 15-45 years, recruited through social media. OUTCOME MEASURES: self-reported lost productivity in days, divided into absenteeism and presenteeism; impact of menstrual symptoms; reasons women give when calling in sick; and women's preferences regarding the implications of menstruation-related symptoms for schools and workplaces. RESULTS: A total of 13.8% (n=4514) of all women reported absenteeism during their menstrual periods with 3.4% (n=1108) reporting absenteeism every or almost every menstrual cycle. The mean absenteeism related to a woman's period was 1.3 days per year. A total of 80.7% (n=26 438) of the respondents reported presenteeism and decreased productivity a mean of 23.2 days per year. An average productivity loss of 33% resulted in a mean of 8.9 days of total lost productivity per year due to presenteeism. Women under 21 years were more likely to report absenteeism due to menstruation-related symptoms (OR 3.3, 95% CI 3.1 to 3.6). When women called in sick due to their periods, only 20.1% (n=908) told their employer or school that their absence was due to menstrual complaints. Notably, 67.7% (n=22 154) of the participants wished they had greater flexibility in their tasks and working hours at work or school during their periods. CONCLUSIONS: Menstruation-related symptoms cause a great deal of lost productivity, and presenteeism is a bigger contributor to this than absenteeism. There is an urgent need for more focus on the impact of these symptoms, especially in women aged under 21 years, for discussions of treatment options with women of all ages and, ideally, more flexibility for women who work or go to school

Short-term recovery after NovaSure? endometrial ablation: a prospective cohort study

Background: Endometrial ablation is a frequently performed treatment for heavy menstrual bleeding, but detailed information about recovery to help inform patients is lacking. Objective: To gain more insight into the short-term recovery after NovaSure (R) endometrial ablation, with the goal of improving preprocedural counselling.Materials and Methods: A total of 61 women who underwent endometrial ablation between March 2019 and November 2021 in a teaching hospital in the Netherlands were included in this prospective cohort study.Main outcome measures: Short-term recovery was investigated through questionnaires in the first week after the procedure. The primary outcome was the Recovery Index (RI-10). Secondary outcomes included health-related quality of life (EQ-5D-5L), pain intensity, use of analgesics, nausea, vaginal discharge, capability of performing activities (domestic chores, sports, work), self-rated health (EQ-VAS) and the feeling of full recovery.Results: A total of 33 women underwent the procedure under local anaesthesia and 28 women under procedural sedation. The RI-10 increased in the first week; median scores on day one, two and seven were 34 (IQR 28.5-41.5), 38.5 (IQR 31-47), and 42 (IQR 37.5-48), respectively. The median time for full recovery was five days. However, 23% of all women were not fully recovered within seven days. Women needed a median time of two days for returning to their work and 5.5 days for sporting activities. There were no differences in recovery between both anaesthesia techniques.Conclusions: Women undergoing endometrial ablation can be informed that most will fully recover within the first week of the procedure and that there is no difference in expected recovery time according to whether the procedure is undertaken with local anaesthesia or conscious sedation. What is new? The short-term recovery after endometrial ablation has been mapped in this trial. This information can be used in counselling women with heavy menstrual bleeding