An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Aesculap AG
- 入组人数
- 106
- 试验地点
- 5
- 主要终点
- Frequency of anastomosis leakage rate
研究概览
简要总结
The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter.
Postoperative complication rate, length of hospital stay, costs, time to perform the anastomosis and handling will serve as secondary endpoints.
The question is addressed, whether a monofilament suture material is as effective as a braided suture material for anastomosis construction within the gastrointestinal tract.
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
- •Age 18 years and older
- •ASA I-III
- •Indication for an elective tumor surgery within the GI tract (stomach, small intestine, large intestine)
- •Written informed consent
排除标准
- •Emergency surgery
- •Peritonitis
- •Patients undergoing an operation due to a tumour within the pancreas, rectum, esophagus
- •Pregnant women and breast-feeding women
- •Chemotherapy
- •Current immunosuppressive therapy
- •Radiotherapy on the treated region within the last 2 months
结局指标
主要结局
Frequency of anastomosis leakage rate
时间窗: participants will be followed for the duration of hospital stay, an expected average of 7 days
Anastomotic leak is defined as radiographic demonstration of a fistula or non-absorbable material drainage from a wound after oral administration, or visible disruption of the suture line during re-exploration.
次要结局
- Reoperation rate(participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Stay in the intensive care unit(participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Length of hospital stay(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Cost(duration of the intervention (approximately 18 months))
- Postoperative complication rate(participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Duration to perform the anastomosis(intraoperatively)
- Handling of the device(End of the Study (approximately 18 months))