A Randomized Controlled Trial Comparing Hand-made Extracorporeal Knotting Versus Clip for Stump Closure in Laparoscopic Appendectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Post operative ileus
研究概览
简要总结
Acute appendicitis is one of the most common causes of emergency abdominal surgery. Laparoscopic appendectomy is now widely used because it offers advantages such as shorter hospital stay, less postoperative pain, and better cosmetic outcomes. However, the optimal technique for appendiceal stump closure remains unclear, and different methods such as endoloops, clips, sutures, and staplers are currently used in clinical practice.
This randomized controlled trial will compare two commonly used stump closure techniques during laparoscopic appendectomy: hand-made extracorporeal knotting and polymeric clip application. Participants will be randomly assigned in a 1:1 ratio to either group. The study outcomes include failure of technique, postoperative ileus, and intra-abdominal infection within 15 days after surgery.
The aim of this study is to determine whether hand-made extracorporeal knotting is more effective than clip application in reducing postoperative complications related to appendiceal stump closure.
详细描述
Acute appendicitis is a major cause of acute abdomen and a frequent indication for emergency surgery. Laparoscopic appendectomy has become the preferred surgical approach due to advantages such as reduced postoperative pain, quicker recovery, lower wound infection rates, and improved cosmetic outcomes. Despite technical advancements, appendiceal stump leakage remains a serious postoperative concern, potentially resulting in intra-abdominal sepsis and reoperation.
A variety of appendiceal stump closure techniques are in use, including endoloops, sutures, staplers, and clips. Both hand-made extracorporeal knotting and polymeric nonabsorbable clips (Hem-o-lok®) are commonly employed and considered safe. Hand-made extracorporeal knotting has potential advantages of lower cost and usability in resource-limited settings, but the optimal closure technique remains controversial and evidence is limited.
This study is designed as a single-center, prospective, parallel-group randomized controlled trial conducted at Abbas Institute of Medical Sciences, Muzaffarabad. A total of 190 patients aged 10-70 years presenting with acute appendicitis and undergoing laparoscopic appendectomy will be enrolled. After diagnostic laparoscopy and confirmation of eligibility, participants will be randomized by simple lottery method into one of two groups:
Intervention Group: appendiceal stump closure using hand-made extracorporeal knotting (modified Tayside knot), with two knots applied.
Comparator Group: appendiceal stump closure using a nonabsorbable polymeric Hem-o-lok® clip.
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
- None
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10 to 70 years
- •Either sex
- •Clinical diagnosis of acute appendicitis with Alvarado score >6
- •ASA physical status I-III
- •Planned laparoscopic appendectomy
排除标准
- •Patient request for open appendectomy
- •Complicated appendicitis (perforation, appendicular abscess, or appendicular mass)
- •Local or diffuse peritonitis
- •Friable or necrotic appendix base
- •Pelvic inflammatory disease
结局指标
主要结局
Post operative ileus
时间窗: within 48 hours of surgery
Postoperative ileus defined as absence of bowel movement, passage of flatus, or audible bowel sounds up to 48 hours after surgery
Intra abdominal infection
时间窗: within 15 days of surgery
Intra-abdominal infection defined as presence of fever, abdominal pain, or systemic symptoms confirmed by CT scan showing intra-abdominal abscess or infection requiring medical or surgical treatment.
次要结局
未报告次要终点
研究者
Haseeb Ul Hassan
Doctor
Abbas Institute of Medical Sciences