Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum (ENDORE)

University Hospital, Rouen

Status

Completed

Conditions

Endometriosis, Rectum

Treatments

Procedure: Rectal nodule excision

Procedure: Rectal/colorectal segmental resection

Study type

Interventional

Funder types

Other

Identifiers

NCT01291576

2009/069/HP

Details and patient eligibility

About

The purpose of this study is to determine whether performing colorectal resection in deep endometriosis infiltrating the rectum is responsible for a higher rate of postoperative digestive and urinary dysfunction when compared to rectal nodules excision (conservation of the rectum).

Full description

The study compare digestive and urinary functional outcomes following surgical management of rectal endometriosis by either colorectal resection or conservative surgery (shaving or full thickness excision of rectal nodules).

Patients managed for rectal endometriosis are randomized in two arms, and followed up for 24 months. The assessment of digestive and urinary functions is performed at 6, 12, 18 and 24 months using standardized questionnaires. Postoperative complications and improvement of endometriosis related pain are also recorded.

Enrollment

60 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

female
age >18 and <45
at least one digestive symptom related to deep endometriosis (pain defecation, either cyclic diarrhea or cyclic constipation, cyclic rectorrhagia)
preoperative work up revealing a deep endometriosis nodule infiltrating the rectum (either muscular or submucosal layer, on less than 50% of rectal circumference) and measuring at least 20 mm
affiliation to the National Social Security System

Exclusion criteria

pregnant women or likely to be at the moment of the surgery
no preoperative hypothesis of rectal involvement
no intraoperative confirmation of the rectal involvement
advanced rectal endometriosis involving rectal mucosa or more than 50% of the rectal circumference (preoperative assessment using rectal endoscopy or ultrasonography)
women unable to give an informed consent (guardianship or trusteeship)