Optimising Surgical Anastomosis in Ileocolic Resection for Crohn's Disease to Reduce Recurrent Disease: A Randomised Controlled Trial Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis (END-to-END Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Postoperative endoscopic recurrence at 6 months
研究概览
简要总结
The aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and Kono-S) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for Crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.
详细描述
Within the surgical IBD society there has been a lot of attention to technical aspects of ileocolic resection aiming to reduce recurrent Crohn's disease after surgery. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection e.g., handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. It is hypothesised that patients who had an end to end reconstruction will have less endoscopic recurrence (less overscoring, and less stases), a better function and consequently health care consumption than the stapled side to side anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
There is no blinding to the treatment allocation for the treating surgeon. The treatment will be blinded for the treating gastroenterologist, the endoscopist and the participants.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged >16 years
- •Ileocolic disease or disease of the neoterminal ileum with an indication for resection
- •Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
- •All patients should have undergone a colonoscopy and a recent update of imaging (e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))- Ability to comply with protocol.
- •Competent and able to provide written informed consent.
- •Patient must have been discussed in the local MDT
排除标准
- •Inability to give informed consent.
- •Patients less than 16 years of age.
- •Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
- •History of cancer < 5 years which might influence patients prognosis
- •Emergent operation.
- •Pregnant or breast feeding.
- •Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.
结局指标
主要结局
Postoperative endoscopic recurrence at 6 months
时间窗: 6 months
The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts \> i2b by central reading
次要结局
- The 5 year reoperation rate for recurrence of disease at the anastomotic site.(5 year)
- Post-operative 30 days complications(30 days after surgery)
- Histologic and clinical recurrence rate at 6 months following ileocolic resection(6 months after surgery)
- Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence(1 year after surgery)
- Inflammatory Bowel Disease Questionnaire (IBDQ)(1 year after surgery)
- Hospital costs(1 year after surgery)
研究者
Willem A. Bemelman
Prof. dr.
Amsterdam UMC, location AMC