The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
Main Line Health
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.
Description
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 rand…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- Drug40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate
if randomized to study drug, participants will take one tablet Rel-CT daily following excisional surgery for endometriosis
Location
- Main Line HealthWynnewood, Pennsylvania