Small bite continuous suture closure vs. mass closure of midline abdominal incision in emergency- A prospective,double blind multicentric, randomized controlled trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 680
- 试验地点
- 3
- 主要终点
- Development of Incisional Hernia at thirty- six months.
研究概览
简要总结
Incisional hernia causes significant morbidity and decreased quality of life postoperatively.
Treatment for repair is costly. Apart from patient-related factors like malnutrition, obesity, smoking and post-operative wound infection, the surgical technique of wound closure and suture material used could potentially be a major determinant of postoperative incisional Hernia. According to European hernia society (EHS) guideline, small bite continuous suture with 2-0 PDS is recommended for the closure of elective midline laparotomy incision.“TheSTICH Trialâ€, conducted on 560 patients in the Netherlands, over a period of three years, in the patients undergoing elective laparotomy in the surgical and gynecological department has shown almost a 50% reduction in the rate of incisional hernia (21% to 13%). Only thirteen RCTs have included both emergency and elective midline laparotomies but none of them reported outcome data separately for emergency or elective subgroup. Only one study by Agrawal et al has compared only emergency laparotomies. But they have compared two different types of sutures namely absorbable and non- absorbable. We could not find any good quality of literature comparing small bite suture technique to mass closure in midline laparotomy incision in an emergency. A similar view was mentioned by both MATCH review and European hernia society and hence they cannot frame a guideline on emergency wound closure technique. Considering the incidence of incisional hernia as 15–20% of total laparotomies, which increases up to 35% in emergency laparotomies, incisional hernia should be considered as a major cause of morbidity. High cost associated with the repair is another major concern. Small bite suture closure technique is now proposed as a standard procedure in elective surgeries. We plan to undertake this study for emergency midline laparotomies, as there are no guidelines for the same.
1.Primary objective : Development of Incisional Hernia at thirty- six months.
2. Secondary objective : .Surgical site infection and Burst abdomen in the post-operative period.
Quality of life at 3 months, 6 months and one year and three year
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •any patient with age more than 18 years, undergoing emergency midline laprotomy.
排除标准
- •Patients with previous abdominal incisions/scar H/O Chronic cough ASA(American society of Anesthesiology) grade 3 & 4 Refractory hypotension, Septic shock Pregnancy.
结局指标
主要结局
Development of Incisional Hernia at thirty- six months.
时间窗: Development of Incisional Hernia at thirty- six months.
次要结局
- 1. Surgical site infection and Burst abdomen in post-operative period. 2.Quality of life at 3 months, 6 months and one year and three year.(1 year and 3 year)