Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439524
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-02-29
Brief Title:
The Effect of Medical Management Following Excisional Surgery for Endometriosis A Randomized Controlled Trial
Sponsor:
Main Line Health
Organization:
Main Line Health
Study Overview
Official Title:
The Effect of Medical Management Following Excisional Surgery for Endometriosis A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
Detailed 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 randomization schedule to reduce selection bias Inclusion criteria will include 1 Patients over the age of 18 planning to undergo an elective laparoscopicrobotic 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 4-weeks of the index surgical procedure 3 Primary language other than EnglishSpanish 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None