Patient Reported Outcomes After Surgery for Rectal Endometriosis

Active, not recruiting

• Conditions: Endometriosis, Rectum; Endometriosis; Endometriosis-related Pain; Endometriosis; Bowel
• Interventions: Other: PROMS

• Registration Number: NCT04204707
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-09
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-19
• Primary Completion: 2023-03-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-10
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 294

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative surgery	PROMS	-
Radical surgery (segmental resection)	PROMS	-

Primary Outcome Measures

Name	Time	Method
The proportion of patients experiencing one of the following symptoms at 12 months postoperatively:	12 months postoperatively	* constipation (1 stool/\>5 consecutive days); * frequent bowel movement (≥3 stools/day); * defecation pain; * anal incontinence (involuntary loss of gas or stools); * dysuria; * bladder atony requiring self-catheterization
The determination of possible risk factors for radical surgery.	3 months postoperatively	based on patient complaints, preoperative imaging techniques and intra operative finding

Trial Locations

Locations (2)

Semmelweis University Hospital; 🇭🇺 Budapest, Hungary

UZ Leuven; 🇧🇪 Leuven, Belgium