Crohn's Extent of Resection Trial (CERT): A Randomised Controlled Trial Comparing Anastomotic Disease Recurrence Following 2cm Versus 10cm Resection Margins for Patients With Ileocolic Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Endoscopic recurrence
研究概览
简要总结
The trial will investigate if removing an additional length of small bowel will result in lower risk of recurrence at the surgical join (anastomosis), thereby decreasing the need for further surgery in the future.
详细描述
The study will be conducted as a randomised controlled trial. The patient will be blinded to the procedure undertaken, as will the endoscopist performing the 6 month post operative colonoscopy. It is not possible to blind the operating team, for obvious reasons.
Patients undergoing elective or urgent ileocolic resection, both primary and redo resections, will be invited to participate in the trial. Randomisation will take place in the operating theatre after a conventional ileocolic resection has been performed. Those patients randomised to the modest resection (10cm margin) will have an additional 8cm of distal small bowel resected prior to the formation of the surgical anastomosis.
All patients will be seen in the colorectal clinic at approximately 6 weeks post operatively for their routine follow up appointment, as is current practice. A colonoscopy will be performed at 6 months post operatively to assess the anastomosis, in keeping with our current practice. Any additional follow up will be at the discretion of the colorectal or gastroenterological teams, in keeping with their clinical practice.
Patients recruited to the trial will not have any additional ongoing following up directly related to their trial participation. At 5 years following the recruitment of the a patient, the medical notes will be reviewed to identify those patients who have had symptomatic recurrence, further surgery and to assess the duration of medication-free interval following surgery.
Performing a colonoscopy at 6 months post operatively to assess the appearances of the surgical anastomosis will assess the primary endpoint. This will be performed by a senior gastroenterological trainee or consultant gastroenterologist who is familiar with assessment of post operative Crohn's disease and the Rutgeert's score. The appearances of the anastomosis will be scored, and biopsies taken from around the anastomosis to assess for microscopic changes. The use of the Rutgeert's score is widely accepted by the gastroenterological community as the standard assessment tool for post operative anastomotic disease recurrence in patients with Crohn's disease.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 16 years or above.
- •Patients with ileocolic Crohn's disease requiring surgical resection
排除标准
- •Patients unable to give informed consent
- •Patients requiring formation of a stoma at the time of surgical resection
- •Patients having less than 200cm of small bowel as assessed intra-operatively
- •Simultaneous strictureplasty or small bowel resection
- •Age <16 or >80
结局指标
主要结局
Endoscopic recurrence
时间窗: 6 months post operatively
The primary objective of the study is to assess whether undertaking a modest ileocolic resection (10cm margins) leads to a reduction in the incidence of Crohn's disease recurrence at the surgical anastomosis as assessed by colonoscopy 6 months post operatively, when compared to a conventional ileocolic resection (2cm margin).
次要结局
- Medication-free interval(5 years post operatively)
- Symptom-free interval(5 years post operatively)
- Time to reoperation(5 years post operatively)
- Extent of plexitis(1 month postoperatively)