Objective: To study the experiences, considerations, and motivations of patients with endometriosis in the decision-making process for deep endometriosis (DE) treatment options. Design: Qualitative study using semi-structured in-depth focus group methodology. Setting: University medical center. Patient(s): A total of 19 Dutch women diagnosed with DE between 27 and 47 years of age. Intervention(s): Not applicable. Main Outcome Measure(s): Focus group topics were disease impact and motives for treatment, expectations of the treatment process, and important factors in the decision process. Result(s): Women reported that pain, fertility, and strong fear of complications are important decisive factors in the treatment process. The goal of conceiving a child is considered important, however, sometimes doctors emphasize this topic too much. It emerged that complication counseling is frequently about surgical complications, whereas side effects of hormonal treatments are neglected. Shared decision making and information about treatment options, complications, and side effects are not always optimal, making it difficult to make a well-considered choice. Despite negative experiences encountered after surgery, the positive effect of surgery ensures that most women do not regret their choice. Conclusion(s):In the treatment decision process for patients with DE, pain is almost always the most important decisive factor. The wish to conceive and strong fear of complications can change this choice. Doctors should understand the importance of fertility for the majority of women, but, also, if this is not considered paramount, respect that view. To improve shared decision making, exploration of treatment goals, training of healthcare providers, and better patient information provision are desirable. (Fertil Steril Ò 2021;115: 702-14. Ó2020 by American Society for Reproductive Medicine.) El resumen está disponible en Español al final del artículo.

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.

Objective To study the preferences and risk tolerance of women suffering from deep endometriosis (DE) with bowel involvement when they have to choose between conservative or surgical. Design Labelled Discrete Choice Experiment (DCE). Setting Dutch academic and non-academic hospitals and online recruitment. Population or Sample A total of 169 patients diagnosed with DE of the bowel. Methods Baseline characteristics and the fear for surgery were collected. Women were asked to rank attributes and choose between hypothetical conservative (medication) 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/or risk on pain, fatigue, pregnancy, endometriosis lesions, mood swings, osteoporosis, temporary stoma and permanent intestinal symptoms were used in this DCE. Results In the ranking osteoporosis is the least important attribute, while in the DCE, a lower chance of osteoporosis is one of the most important drivers when choosing a conservative treatment. Women with previous surgery show less fear for surgery compared to women without surgery. The low anterior resection syndrome is almost equally important for patients as the chance of pain reduction. Pain reduction has higher importance than improving fertility chances even in women with a future child wish. Conclusions The risk of suffering from LARS as a result of treatment is almost equally important as the reduction of pain symptoms. Women with previous surgery experience less fear for surgery compared to women without a surgical history.

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 INTEREST(S) 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.