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
- 1
- 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
研究组 & 干预措施
resection of the mesentery
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
干预措施: 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 distribut (Procedure)
Kono S Anastomosis
Kono-S anastomosis:
the mesentery is not removed but cutted close to the bowel. The bowel is then divided transversely by placing a linear stapler perpendicular to the intestinal lumen and the mesentery. The corners of the two staple lines are reinforced and the two stumps are approximated using 5-7 sutures to create the column.
If the caliber of the two intestinal segments differs significantly, the sutures should be spaced to evenly distribute the surplus tissue of the larger segment, in order to achieve good approximation and stable support for the anastomosis. To create the anastomosis, an antimesenteric longitudinal enterotomy (or colostomy) is performed on each stump to allow a transverse lumen of 7 cm in diameter for the small bowel or closer to 8 cm for the colon. In this way the supporting column is located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lum
干预措施: Kono S Anastomosis (Procedure)
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