Patient Reported Outcomes After Surgery for Rectal Endometriosis

N/AActive Not RecruitingNCT04204707

Universitaire Ziekenhuizen KU Leuven294 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

294

Conditions

Endometriosis Endometriosis, Rectum Endometriosis-related Pain Endometriosis; Bowel

Interventions

PROMSOTHER

Patient Reported Outcomes after different types of surgery for rectal endometriosis

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (2)

UZ Leuven

Leuven, Belgium

Semmelweis University Hospital

Budapest, Hungary

Outcomes

Primary Outcomes

The proportion of patients experiencing one of the following symptoms at 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

Time frame: 12 months postoperatively

The determination of possible risk factors for radical surgery.

based on patient complaints, preoperative imaging techniques and intra operative finding

Time frame: 3 months postoperatively

Data from ClinicalTrials.gov

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