Suture Techniques to Reduce the Incidence of The inCisional Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 576
- 试验地点
- 1
- 主要终点
- Incisional hernia occurrence within one year after operation clinical and/or radiographically detected
研究概览
简要总结
The objective of the study is reduction of the incidence of the most frequent complication of abdominal surgery, incisional hernia. In this multi center double-blinded prospective randomized controlled trial, in which a new suture technique using small bites is compared with the traditionally applied large bites (mass closure) technique for midline incisions.
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, Investigator)
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
- •Signed informed consent
- •All laparotomies with a midline incision
- •Age > 18 years
排除标准
- •Previous incisional hernia after midline incision
- •Previous surgery through a midline incision within 3 months
- •Pregnancy (in women)
研究组 & 干预措施
Large tissue bites
As control the conventional large bites technique (mass closure) will be applied in with bites widths of 1 cm and inter-suture spacing of 1 cm with the use of PDS plus ll 1-0 double loop suture material with a 48 mm needle.
干预措施: Closure of the abdominal wall after midline incisions (Procedure)
small tissue bites
In the other group of 288 patients the small bites technique will be applied with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of PDS plus ll 2-0 single suture material with a 31 mm needle placed in the linea alba. In the small bites technique, twice as many stitches will be placed per sutured cm, with a smaller needle and thinner suture material.
干预措施: Closure of the abdominal wall after midline incisions (Procedure)
结局指标
主要结局
Incisional hernia occurrence within one year after operation clinical and/or radiographically detected
时间窗: one year
次要结局
- postoperative complications; in particular wound infection (during admission), burst abdomen (during admission) and wound pain (measured with a visual analog scale (VAS) during the first 6 days after surgery).(one month)
研究者
joris harlaar
Prof dr JF Lange, professor of Surgery
Erasmus Medical Center