Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- 6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification.
研究概览
简要总结
RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs.
HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction.
DESIGN Randomised superiority study
POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum
INTERVENTION Kono S and end to end hand sewn anastomosis
USUAL CARE Side to side stapled anastomosis
OUTCOME Endoscopic recurrence (local and central reading) at 6 months
SAMPLE 25% reduction in 2:1 ratio -> 126 + 63 = 189 patients
KEYWORDS Crohn, ileocolic resection, recurrence
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged >18 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 MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
- •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.
- •Patients undergoing repeated ileocolic resection.
- •History of cancer < 5 years which might influence patients prognosis
- •Emergent operation. Pregnant or breast feeding.
结局指标
主要结局
6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification.
时间窗: 6 months
The comparison of 6 months endoscopic recurrence between local and central reading of recordings of endoscopy using the modified Rutgeerts classification.
次要结局
- Inflammatory Bowel Disease Questionnaire (IBDQ)(1 year)
- Morbidity(1 year)
- Clinical Recurrence(1 year)
- Hospital Costs(1 year)
研究者
Vittoria Bellato
Principal Investigator
IRCCS San Raffaele