Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil) One Layer Running(A) vs. Two-Layer Suture Technique (B)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Frequency of postoperative Complications
研究概览
简要总结
The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal surgery as part of a controlled randomized single blinded parallel group trial. The applicability and safety of the strand material used in two suture techniques (2-layer suture technique vs. 1-layer running) are to be tested on the basis of handling characteristics, the operative time consumed for the construction of the 1st anastomosis, the average time of the hospital duration for both patient groups, and the frequency of postoperative complications after discharge, 1 month and a maximum of 3-4 months. The used suture units are counted and the length of sutures determined which will be an indirect measurement of the costs of suture material for the two techniques.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, undergoing a gastrointestinal hand made one-layer running (A) or two-layer (B) anastomotic procedure where the use of synthetic absorbable surgical suture material is indicated.
- •Written consent to participate in the study
排除标准
- •Emergency patients that cannot be properly informed about the clinical trial and cannot give their written consent
- •Pregnancy or lactation period
- •Patients suffering from a diffuse purulent peritonitis or generalized diseases, which can have consequences for the healing of the asnastomosis (e.g. ubalanced diabetes, progressed uremia, massive hypoproteinaemia, sever jaundice, generalized intraabdominal tumor metastases, severe tumorous cachexia, severe avitaminosis, chronic liver disease.
- •Patients who are undergoing a therapeutic procedure, which can have consequences for the healing of the anastomosis (e.g. treatment with corticosteroids or cytostatics, local radiation in the operating area)
- •Laparoscopial Procedures
- •Patients who are not willing to cooperate and legally incapacitated people
结局指标
主要结局
Frequency of postoperative Complications
时间窗: discharge, 1 month and a maximum of 3-4 months
次要结局
- Operation time to construct the first anastomosis(intraoperative)
- length of hospitalization(postoperative)
- costs of suture material(intraoperative)
- handling characteristics(intraoperative)