Patient Reported Outcomes After Surgery for Rectal Endometriosis

NCT04204707 | Active Not Recruiting

• 1 other identifier: S62986
• Study Type: observational
• Target: 294
• Locations: 2 countries
• Sites: 2

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.

Conditions

Endometriosis; Endometriosis, Rectum; Endometriosis-related Pain; Endometriosis; Bowel

Outcome Measures

Primary Outcomes (2)

• 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

  12 months postoperatively

• The determination of possible risk factors for radical surgery.

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

  3 months postoperatively

Study Arms (2)

Conservative surgery

Other: PROMS

Radical surgery (segmental resection)

Other: PROMS

Interventions

PROMS OTHER

Patient Reported Outcomes after different types of surgery for rectal endometriosis

Conservative surgery; Radical surgery (segmental resection)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women scheduled for a multidisciplinary laparoscopic surgery for rectal endometriosis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Semmelweis University: collaborator

Study Sites (2)

UZ Leuven

Leuven, 3000, Belgium

Location

Semmelweis University Hospital

Budapest, Hungary

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Carla Tomassetti, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 19, 2019
• Study Start: December 9, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); BE (1)