Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- 6-month global postoperative morbidity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged ≥ 18 years,
- •patients presenting with ulcerative colitis or indeterminate colitis requiring completion proctectomy
- •patients who have given informed consent
排除标准
- •indication for total proctocolectomy in one-stage or traditional 2-stage fashion
- •Crohn's disease,
- •pelvic radiotherapy,
- •indication for total mésorectum excision
- •vulnerable patient under the French laws
研究组 & 干预措施
Experimental
ileal pouch-anal anastomosis without diverting loop ileostomy
干预措施: ileal pouch-anal anastomosis with diverting loop ileastomy (Procedure)
Control
ileal pouch-anal anastomosis with diverting loop ileostomy
干预措施: ileal pouch-anal anastomosis with diverting loop ileastomy (Procedure)
结局指标
主要结局
6-month global postoperative morbidity
时间窗: 6 months
Number and qualification of surgical and medical complications that may require redmission during the 6 months following the operative procedure: * SBO * ileostomy prolapse * parastomial hernia * dehydration * skin erosions, that may require readmission * anastomotic leakage * incisional hernia.
次要结局
未报告次要终点