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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00687-50 | Other Identifier | IDRCB number |
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Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy.
Total proctocolectomy with IPAA is the gold standard for surgical management of ulcerative colitis (UC). This demanding procedure is often performed in 2 or 3 stages, namely subtotal colectomy, completion proctectomy with IPAA and defunctioning ileostomy closure. Subtotal colectomy with double stoma is first performed to allow nutritional support, reduce inflammation and stop immunosuppressive agents. Completion proctectomy with IPAA is then performed on a healthier patient. Hence, the need for a systematic defunctioning ileostomy is questioned. No study addressed specifically the question of completion proctectomy, whereas it concerns 36% to 42% of patients undergoing IPAA. Globally, the overall 6-month morbidity rate is 55% in case of stoma creation vs. 30% otherwise in IPAA.
Moreover, defunctioning ileostomy has several drawbacks including an additional surgical procedure (stoma closure), a worse quality of life before closure, and the risk of dehydration that may require readmission. Following stoma closure, the risk of anastomotic leakage is around 4%. Overall, during the stoma period, 8% of patients will require reoperation. Finally, the risk of incisional hernia is 15-20% at the ex-ileostomy site.
Therefore, the aim of this trial is to assess the need for a systematic defunctioning ileostomy after completion proctectomy with IPAA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | ileal pouch-anal anastomosis without diverting loop ileostomy |
|
| Control | Active Comparator | ileal pouch-anal anastomosis with diverting loop ileostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ileal pouch-anal anastomosis with diverting loop ileastomy | Procedure | Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month global postoperative morbidity | Number and qualification of surgical and medical complications that may require redmission during the 6 months following the operative procedure:
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura BEYER, MD | Contact | 0491968514 | laura.beyer@ap-hm.fr | |
| Amandine Rolland-Brun | Contact | 0491381245 | promotion.interne@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| EMILIE GARRIDO PRADALIE | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Marseille | Recruiting | Marseille | 13354 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31830976 | Derived | Beyer-Berjot L, Baumstarck K, Loubiere S, Vicaut E, Berdah SV, Benoist S, Lefevre JH; GETAID Chirurgie group. Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch-anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271). BMC Surg. 2019 Dec 12;19(1):192. doi: 10.1186/s12893-019-0657-7. |
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|
| ileal pouch-anal anastomosis with diverting loop ileastomy | Procedure | Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy. |
|
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D016737 | Proctocolectomy, Restorative |
| ID | Term |
|---|---|
| D003082 | Colectomy |
| D000099090 | Surgical Procedures, Colorectal |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000078542 | Proctectomy |
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