Patient Reported Outcomes After Surgery for Rectal Endometriosis (PROCURE)

December 4, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

294

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Hungary
      • Budapest, Hungary
        • Semmelweis University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Women scheduled for a multidisciplinary laparoscopic surgery for rectal endometriosis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conservative surgery
Other: PROMS
Patient Reported Outcomes after different types of surgery for rectal endometriosis
Radical surgery (segmental resection)
Other: PROMS
Patient Reported Outcomes after different types of surgery for rectal endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months postoperatively
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
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Semmelweis University

Investigators

  • Principal Investigator: Carla Tomassetti, MD, PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2019

Primary Completion (Actual)

March 31, 2023

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S62986

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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