Active — Not RecruitingNot Applicable

Patient Reported Outcomes After Surgery for Rectal Endometriosis

Belgium, Hungary294 participantsStarted 2019-12-09

Plain-language summary

To describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 18 - 45 years (both inclusive) * BMI \<35 * Complaining of infertility and/or pain * Deep endometriosis infiltrating the rectum on at least one imaging technique up to 15 cm from the anus and involving at least the muscularis layer in depth Exclusion Criteria: * Refusal of bowel resection/stoma * History of laparotomy for endometriosis * (history of) Hysterectomy * Suspected pelvic malignancy * Pregnancy * Impossibility for postoperative follow-up in our hospital

What they're measuring

The proportion of patients experiencing one of the following symptoms at 12 months postoperatively:

Timeframe: 12 months postoperatively

The determination of possible risk factors for radical surgery.

Timeframe: 3 months postoperatively

Trial details

NCT IDNCT04204707

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-03-31

View on ClinicalTrials.gov More Endometriosis trials