Assessment of the Leakage Rate of Ileo-colic Sutured Anastomoses Using a Polydioxanone Based Suture Material After Laparoscopic or Open Right Hemicolectomy to Treat Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 249
- 试验地点
- 4
- 主要终点
- Rate of anastomosis leakage
研究概览
简要总结
The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to the anastomosis leakage rate published in the literature for totally handsewn or stapled-handsewn ileo-colic anastomosis.
详细描述
The study will include patients with right colon cancer, treated with elective colectomy and with local curative intention, in whom primary anastomosis with no protective stoma will be performed. Right colectomy is defined as a resection of terminal 10 cm of ileum, the cecum, the ascending right colon, and right third or half of the transverse colon followed by ileo-colostomy.The anastomosis leakage rate after right-sided hemicolectomy is the most important complication, because it leads to further morbidity of the affected patients. The anastomosis leakage rate ranges between 1-10% depending on the study population (cancer patients vs. non-cancer patients) and the type of anastomosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a primary, elective either open or laparoscopic right hemicolectomy or right extended hemicolectomy due to malignancy with the creation of an intracorporeal or extracorporeal ileo-colic anastomosis.
- •Either complete hand-sewn anastomosis or partial sutured anastomosis (e.g. combination of stapling and suturing)
- •Open or laparoscopic as well as conversion from open to laparoscopic surgery
- •Absence of peritoneal carcinomatosis
- •Absence of vascular, nervous or bone infiltration
- •Age ≥ 18 years
- •Written data protection declaration (Written Informed consent)
排除标准
- •Left hemicolectomy or left extended hemicolectomy or sigma resection
- •Inflammatory bowel disease (e.g. Crohn´s disease)
- •Emergency surgery
- •Previous abdominal surgery with bowel resection
- •Re-operation of an anastomosis (anastomosis revision surgery)
- •Need for stoma creation
- •Non-compliant patients
- •Participation in an interventional randomized controlled study (RCT)
结局指标
主要结局
Rate of anastomosis leakage
时间窗: until 30 days postoperatively
An anastomosis leak is defined as " leak of luminal contents from a anastomotic site between two hollow viscera" diagnosed (1) radiologically, by a radiographic enema with hydro soluble contrast or by computerized tomography with the presence of intra-abdominal collection adjacent to the anastomosis; (2) clinically with evidence of extravasation of bowel content or gas through a wound or drain; (3) by endoscopy, or (4) intraoperatively. Anastomosis leak will be classified and graded according to Clavien-Dindo. Grade I: Anastomosis leakage requiring no active intervention (e.g. antibiotics) Grade II: Anastomosis leakage requiring active radiological intervention but manageable without surgical intervention. Grade III: Anastomosis leakage requiring surgical re-intervention. Grade IV: Anastomosis leakage leading to life-threatening condition requiring IC /ICU management Grade V: Anastomosis leakage leading to death of the patient
次要结局
- Rate of complications(discharge, 30 days postoperatively, 1 year postoperatively)
- Mortality rate(30 days postoperatively, 1 year postoperatively)
- Surgical Site infection rate(30 days and 12 months after surgery)
- Quality of Life, using EQ5D5L(preoperatively, 30 day postoperatively and 12 months postoperatively)
- Bowel function assessment(Day of discharge after surgery, 30 days postoperatively, 1 year postoperatively)
- Handling of the used suture material(interoperatively)
- Patient satisfaction(30 days postoperavely, 12 months postoperatively)
- Hernia rate(12 months postoperatively)
- Rate of complications(discharge, 30 days postoperatively, 1 year postoperatively)
- Mortality rate(30 days postoperatively, 1 year postoperatively)
- Surgical Site infection rate(30 days and 12 months after surgery)
- Length of hospital stay(day of discharge after surgery)
- Handling of the used suture material(interoperatively)
- Patient satisfaction(30 days postoperavely, 12 months postoperatively)
- Quality of Life, using EQ5D5L(preoperatively, 30 day postoperatively and 12 months postoperatively)
- Bowel function assessment(Day of discharge after surgery, 30 days postoperatively, 1 year postoperatively)
- Hernia rate(12 months postoperatively)