Resection of the Mesentery With Functional End-to-end Anastomosis vs Kono Anastomosis in Preventing Relapse After Ileocolic Resection for Primary Crohn Disease: a Prospective, Randomized, Controlled Trial Remeasure CD TRial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- endoscopic recurrence (Rutgeerts score i2 or greater) at 6,12, 18 months.Endoscopic recurrence was defined if Rutgeerts > i2 (>5 aphthous lesions or larger lesions confined to anastomosis), i3 (diffuse ileitis), or i4 (diffuse inflammation with large ulc
研究概览
简要总结
Aim of the present study is to compare a stapled, functional end-to-end, ileo-colic anastomosis with removal of the mesentery vs the manual, functional end-to-end, ileo-colic Kono-S anastomosis with mesentery preservation, in terms of peri-operative safety, and efficacy in preventing endoscopic recurrence after ileocolic resection for Crohn Disease. Patients presenting with ileocolic primary Crohn disease either not suitable for medical treatment or with contraindications for therapy i.e: occlusion, abscess, contraindications to the use of biologics
详细描述
Patients who meet inclusion criteria will be randomized between two surgical procedures:
The excision of the mesentery (group A) and ileocolic anastomosis and the Kono-S anastomosis (group B) after ileocolic or ileo-cecal resection. The operation could be performed with open or laparoscopic approach.
Excision of the mesentery:
the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribution over the surface of the contiguous intestine. The anastomosis between colon and ileum is than performed mechanically end to end.
Kono-S 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients > 18 years
- •Histological diagnosis of Crohn's Disease
- •Patient's ability to read and understand the documentation concerning the study and the Informed consent
- •Ileocolic disease requiring resection
排除标准
- •Older than 70
- •Recurrent disease, previous surgery for CD
- •Gastroenterologists or patients not willing to maintain a drug washout for six months
- •Emergency surgery
结局指标
主要结局
endoscopic recurrence (Rutgeerts score i2 or greater) at 6,12, 18 months.Endoscopic recurrence was defined if Rutgeerts > i2 (>5 aphthous lesions or larger lesions confined to anastomosis), i3 (diffuse ileitis), or i4 (diffuse inflammation with large ulc
时间窗: From the treatment a close follow up is performed at 6, 12 and 18 months.The majority of endoscopic examinations were centrally performed. In few cases check was performed in separated centers and a "recording video clip" of the endoscopy was assessed fo
次要结局
未报告次要终点
研究者
Lucia Borsotti
Michela Mineccia, MD
Azienda Ospedaliera Ordine Mauriziano di Torino