Patient Reported Outcomes After Surgery for Rectal Endometriosis

Endometriosis Clinical Trial

— PROCURE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04204707
• Other study ID #: S62986
• Status: Active, not recruiting
• Start date: December 9, 2019
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 294
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2023
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• PROMS
Patient Reported Outcomes after different types of surgery for rectal endometriosis

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Hungary	Semmelweis University Hospital	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Semmelweis University

Countries where clinical trial is conducted

Belgium,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The determination of possible risk factors for radical surgery.	based on patient complaints, preoperative imaging techniques and intra operative finding	3 months postoperatively