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Patient Reported Outcomes After Surgery for Rectal Endometriosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04204707
Acronym
PROCURE
Enrollment
294
Registered
2019-12-19
Start date
2019-12-09
Completion date
2025-07-31
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERPROMS

Patient Reported Outcomes after different types of surgery for rectal endometriosis

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER
Semmelweis University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years

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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of patients experiencing one of the following symptoms at 12 months postoperatively: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
The determination of possible risk factors for radical surgery.3 months postoperativelybased on patient complaints, preoperative imaging techniques and intra operative finding

Countries

Belgium, Hungary

Contacts

PRINCIPAL_INVESTIGATORCarla Tomassetti, MD, PhD

UZ Leuven

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026