NCT05433688已完成不适用
Prospective, Mono-center, Randomized, Single-blinded, Controlled Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Time to perform the anastomosis
研究概览
简要总结
The study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (Symmcora® mid term, UBS) vs. a conventional suture (Novosyn®, CS). Patient will be randomly allocated in a 1:1 ratio to either the UBS group or the CS group to perform the gastro-jejunal anastomosis (GJA) and the jejuno-jejunal anastomosis (JJA).
The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 an elective, primary robotic, assisted gastric bypass surgery (with a BMI ≥40 kg/m2 or with a BMI ≥35 kg/m2) with one or more of the following comorbidities: refractory arterial hypertension, type 2 diabetes mellitus and/or proven sleep apnea) with the need to close the gastro-jejunal anastomosis (GJA) and jejuno-jejunal anastomosis (JJA).
- •Age ≥18 years
- •Written informed consent
排除标准
- •Emergency surgery
- •Previous gastric surgery
- •History of chronic steroid use
- •Pregnancy or breastfeeding
- •Patients with hypersensitivity or allergy to the suture material
- •Non compliance
- •Participation in another randomized controlled trial
研究组 & 干预措施
UBS
unidirectional barbed suture (Symmcora® mid term, UBS)
干预措施: Robotic assisted gastric bypass surgery (Device)
CS
conventional suture (Novosyn®, CS)
干预措施: Robotic assisted gastric bypass surgery (Device)
结局指标
主要结局
Time to perform the anastomosis
时间窗: intraoperatively
Time to perform the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis
次要结局
- Anastomotic leak rate over postoperative period(until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively)
- Rate of Anastomosis bleeding over postoperative period(until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively)
- Cumulative Frequency of other complications according to "Clavien-Dindo" over postoperative period(until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively)
- Rate of Re-anastomosis over postoperative period(until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively)
- Assessment of the handling of the unidirectional barbed suture(intraoperatively)
- Patient pain (VAS)(until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively)
- Gastric fistula rate over postoperative period(until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively)
- Rate of Obstruction over postoperative period(until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively)
- Total operation duration(intraoperatively)
- Bariatric Analysis and Reporting Outcome System (BAROS)(preoperative, 30 days and 12 months post-surgery)
- Anastomosis stenosis rate over postoperative period(until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively)
- Length of postoperative stay(until discharge approximately 10 days after surgery)
- Total procedure costs(until discharge approximately 10 days after surgery)
- Patient satisfaction (VAS)(until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively)
- Course of Health Status measured with EQ-5D-5L Score(preoperative, 30 days and 12 months post-surgery)
- Assessment of the barbed suture compared to a conventional suture(intraoperatively)
研究者
研究点 (1)
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