Short Stitch Versus Long Stitch Suture Technique Using Monomax® for Abdominal Wall Closure After Primary Median Laparotomy. A Randomized, Controlled, Double-blinded, Multicenter, International Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 425
- 试验地点
- 16
- 主要终点
- Incisional hernia rate
研究概览
简要总结
The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia. Several suture technique and suture material have been used but the incidence of this complication still lies between 9 -20%. Synthetic suture material which have become available over the last decades have the advantage that they are degraded by the body system and fully absorbed within 70-180 days; however they loss 50% of their initial strength already after 14-30 days and may not be the optimal suture material for abdominal wall closure. A new suture material (Monomax®) was developed with an extra-long absorption profile, high elasticity and with a superior initial strength. Therefore, the ESTOIH-Study was designed to investigate the influence of the stitch length on the occurrence of incisional hernia using the extra-long term absorbable, elastic, monofilament suture (Monomax®).
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
- Double (Participant, Outcomes Assessor)
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
- •Patients undergoing an elective, primary median laparotomy with an incision length of ≥ 15 cm
- •Expected survival time longer than 1 year
- •ASA I-III
- •Written informed consent
排除标准
- •Emergency surgery
- •Patient undergoing surgery due to a pancreas carcinoma
- •Patients who will be operated due to an abdominal aortic aneurysm
- •Peritonitis
- •Coagulopathy
- •Current immunosuppressive therapy (more than 40 mg of a corticoid per day or azathioprin)
- •Chemotherapy within the last 2 weeks before operation
- •Radiotherapy of the abdomen within the last 6 weeks before operation
- •Pregnant women (pregnancy test has to be performed)
- •Severe neurologic and psychiatric disease
- •Lack of compliance
研究组 & 干预措施
Long stitch group
Long stitch suture technique Stitch interval = 10 mm; Lateral = 10 mm
干预措施: Long stitch (Device)
Short stitch group
Short stitch technique for AWC stitch interval = 5 mm; Lateral 5 - 8 mm
干预措施: Short Stitch (Device)
结局指标
主要结局
Incisional hernia rate
时间窗: 1 year postoperatively
Incisional hernia rate 1 year postoperatively (assessment by ultrasound).
次要结局
- Long Term Incisional hernia rate(3 and 5 years postoperatively)
- Frequency of burst abdomen(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Length of postoperative hospital stay(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Frequency of wound infections(participants will be followed for the duration of hospital stay, an expected average of 10 days and 30 days postop)
- Long Term Wound healing complications(until 1 year postoperatively)
- Costs(until 5 years postop)
- Reoperation due to burst abdomen(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Wound healing complications(until 30 days postoperatively)
- Long term Wound infections(1 year postoperatively)
- Course of Health status with EQ-5D Score(preop, 30 days postop, 1 year, 3 years, 5 years postop)