Patient Reported Outcomes After Surgery for Rectal Endometriosis (PROCURE)

Universitaire Ziekenhuizen KU Leuven

Status: Active, not recruiting

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

Treatments: Other: PROMS

Study type: Observational

Funder types: Other

Identifiers

NCT04204707

S62986

Details and patient eligibility

About

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.

Enrollment: 294 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

294 participants in 2 patient groups

Conservative surgery

Treatment:

Other: PROMS

Radical surgery (segmental resection)

Treatment:

Other: PROMS