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Completed

NCT Number: NCT04204707

Patient Reported Outcomes After Surgery for Rectal Endometriosis

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.

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Key information

Conditions

Endometriosis Endometriosis, Rectum Endometriosis-related Pain Endometriosis; Bowel Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

UZ Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROMS

Other

Patient Reported Outcomes after different types of surgery for rectal endometriosis

Primary outcomes

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

    Time frame: 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

  2. The determination of possible risk factors for radical surgery.

    Time frame: 3 months postoperatively

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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Semmelweis University

Registry information

Official study title

PROCURE: Patient Reported Outcomes After Surgery for Deep Endometriosis Infiltrating the Muscular Layer of the Rectum: a Prospective Study

Acronym: PROCURE

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
Dec 19, 2019
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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