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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal/colorectal segmental resection | Active Comparator |
| |
| Rectal nodule excision | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal/colorectal segmental resection | Procedure | Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of women experiencing a postoperative digestive or urinary dysfunction | At least one of following symptoms:
| 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of women experiencing postoperative pain related to endometriosis | Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain | 24 months |
| Percentage of women experiencing a postoperative digestive or urinary dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horace Roman, MD PhD | Rouen University Hospital, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Gynécologie et Obstétrique, CHU Jean de Flandre | Lille | 59000 | France | |||
| Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31820806 | Derived | Roman H, Tuech JJ, Huet E, Bridoux V, Khalil H, Hennetier C, Bubenheim M, Branduse LA. Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial. Hum Reprod. 2019 Dec 1;34(12):2362-2371. doi: 10.1093/humrep/dez217. | |
| 30052994 | Derived |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000285 | Administration, Rectal |
| ID | Term |
|---|---|
| D058956 | Administration, Mucosal |
| D000287 | Administration, Topical |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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|
| Rectal nodule excision | Procedure | Either full thickness excision or rectal shaving |
|
|
At least one of following symptoms:
|
| 12 months |
| Biberoglu & Behrman score | Evaluation of endometriosis related pain using the above mentioned scale | 24 months |
| SF-36 quality of life scale | 24 months |
| The Gastrointestinal Quality of Life Index (GIQLI) | 24 months |
| The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS) | 24 months |
| Wexner questionnaire related to anal incontinence | 24 months |
| percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis | 24 months |
| Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis | 24 months |
| Paris |
| 75020 |
| France |
| Rouen University Hospital | Rouen | 76031 | France |
| Roman H, Chanavaz-Lacheray I, Ballester M, Bendifallah S, Touleimat S, Tuech JJ, Farella M, Merlot B. High postoperative fertility rate following surgical management of colorectal endometriosis. Hum Reprod. 2018 Sep 1;33(9):1669-1676. doi: 10.1093/humrep/dey146. |
| D000091662 | Genital Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 | Therapeutics |