the effect of medical management following excisional surgery for endometriosis: a randomized controlled trial

Conditions: Endometriosis

Summary: the goal of this investigator-initiated single-site clinical trial is to compare the overall quality of life of participants taking relugolix combination therapy (rel-ct) following excisional surgery for endometriosis to participants that do not take rel-ct following the same surgery. rel-ct is an fda approved form of medical treatment for endometriosis. it is known to work in treating endometriosis pain. however, investigators do not know whether or not there is a benefit to beginning rel-ct immediately following surgery. this study will test if patients who take rel-ct after surgery have better quality of life and less chance the endometriosis comes back, requiring additional surgery. the main question it aims to answer is: - does taking rel-ct following excisional surgery for endometriosis result in higher endometriosis health profile 30 (ehp-30) scores, indicating a positive impact on overall health-related quality of life and well-being? participants will: * be randomly assigned to one of two treatment groups. one treatment group will take study drug rel-ct after having excisional surgery, and the other treatment group will just have the surgery alone. * be asked to complete questionnaires, called the endometriosis health profile 30 (ehp-30) at 4 timepoints. the first time is before surgery, then at follow-up visits at 1 month, 3 months, and 6 months. the survey has 30 questions that ask about pain, control, powerlessness, emotional well-being, social support, and self-image. researchers will compare the two treatment groups (rel-ct and non rel-ct) to see if there is a change in ehp-30 scores.

the design of this study will be an unblinded randomized controlled trial of medical suppression with once daily relugolix combination therapy (rel-ct) following excisional surgery for endometriosis performed by high volume minimally invasive gynecologic surgeons. women over the age of 18 scheduled to undergo a laparoscopic surgery for endometriosis will be screened and if agree and consented to participate will be randomized to either rel-ct following surgery or no post-operative hormonal suppression using a block randomization with blocks 2 and 4. the surgeon will not have access to the randomization schedule to reduce selection bias. inclusion criteria will include: 1) patients over the age of 18 planning to undergo an elective laparoscopic/robotic procedure for known or suspected endometriosis. exclusion criteria will include: 1) patients with known contraindications to rel-ct; 2) any form of hormonal suppression of endometriosis within the protocol guidelines; 3) primary language other than english/spanish; 4) patients without histologic evidence of endometriosis following their surgical procedure; 5) patients interested in pregnancy within the 12 months following their surgical procedure. the primary outcome will be change in endometriosis health profile 30 (ehp-30) score. a preoperative ehp-30 will be completed by all patients enrolled in the study within 4 weeks of their scheduled surgical procedure and then again postoperatively at 1 month, 3 months, and 6 months. investigators expect that postoperative use of rel-ct will lead to a clinically meaningful improvement in ehp-30 scores compared to surgery alone. in addition, investigators will gather data on our secondary outcomes: these data could be very helpful in informing providers and patients of the utility of medical suppression of endometriosis using rel-ct following surgery.

Eligibility criteria:
inclusion criteria * age ≥ 18 years * planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis exclusion criteria -a known contraindication to rel-ct. contraindications include: * high risk of arterial, venous thrombotic, or thromboembolic disorder * pregnancy known osteoporosis * current or history of breast cancer or other hormone-sensitive malignancies * known hepatic impairment or disease * undiagnosed abnormal uterine bleeding * known hypersensitivity to components of rel-ct * the patient did not discontinue hormonal suppression within the required timeline: trans-dermal, oral medication, patch, or vaginal ring: day before surgery intrauterine device or sub-dermal implant: removed at surgery injectable medication: at least 12 weeks before surgery * primary language other than english/spanish * interested in pregnancy within the 6 months following the surgical procedure. * if pregnancy test performed during pre-surgical work up is positive, the patient will no longer be a candidate for endometriosis surgery and will therefore not be eligible for the study. * patients without histologic evidence of endometriosis following their surgical procedure will be removed from the study prior to receiving the study intervention. * patients who undergo a surgical intervention more invasive than the planned laparoscopic or robotic excisional surgery, such as open abdominal surgical repair, will be removed from the study prior to receiving the study intervention.