Clinical Profile of Appendicitis and Comparative Study for Use of Harmonic Scalpel (Seal and Cut) and Suture Ligation of Base of Appendix During Laparoscopic Appendectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
This study is a comparative study between use of suture ligation vs harmonic scalpel for sealing and cutting the base of appendix.
The ideal method for closing the appendix stump should be safe, reliable, simple to use, and cost-effective. Various techniques have been introduced for this purpose, each with its advantages and disadvantages. However, no clear consensus has been reached in the literature regarding which technique is superior.
This study is to compare the two groups in terms of operative time and postoperative complications and to reach a conclusion as to which one of the two is superior.
详细描述
Acute appendicitis is one of the most common causes of emergency abdominal surgery worldwide. Laparoscopic appendectomy has become the standard of care due to its advantages of faster recovery and reduced postoperative complications. A key step in the procedure is the secure closure of the base of the appendix to prevent intra-abdominal leakage and stump complications. Traditionally, this is done using intracorporeal suture ligation or endoloops. However, the introduction of energy devices such as the harmonic scalpel has offered a potential alternative that combines cutting and coagulation, potentially reducing operative time and simplifying the procedure.
This prospective interventional study aims to compare the effectiveness and safety of harmonic scalpel (seal-and-cut technique) versus conventional suture ligation for closure of the appendix base during laparoscopic appendectomy in patients with uncomplicated acute appendicitis. A total of 60 patients will be enrolled and randomized into two groups: Group A (Harmonic Scalpel) and Group B (Suture Ligation). Both groups will undergo standard laparoscopic appendectomy with the only variable being the method of securing the appendix stump.
The primary outcomes of interest include operative time,Postoperative leak, Postoperative ileus,Surgical site infection and Hospital Stay and secondary outcome of interest include Recovery and Postoperative complications. Follow-up will be done on postoperative day 1, day 7, day 30 and 3 months. This study seeks to determine whether the harmonic scalpel offers a safe and effective alternative to conventional ligation, potentially simplifying surgical technique and improving patient outcomes.
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
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 - 65 years
- •Patient willing to undergo laparoscopic appendectomy
- •Acute appendicitis confirmed by clinical and radiological analysis
- •Alvarado Score ≥7
- •Alvarado Score ≥5 with positive ultrasound findings
排除标准
- •Patient with base of appendix highly inflamed / gangrenous
- •Any other intra-abdominal pathology other than acute appendicitis, e.g., appendicular mass, appendicular abscess, tuberculosis, carcinoid tumor, pelvic inflammatory disease, ovarian tumors, ceacal mass, etc.
- •Patients declared unfit for laparoscopic surgery during preoperative assessment
- •Patients having severe co morbid condition - COPD/CAD/CHF
结局指标
主要结局
Operative time
时间窗: Intraoperative( measured during surgical procedure on day 1)
Total duration of surgery in minutes, measured from skin incision to completion of appendix base closure. Used to compare efficiency between harmonic scalpel and suture ligation techniques.
次要结局
- Position of appendix(Intraoperative ( day 1))
- Postoperative Leak(Upto 7 days post-operation)
- Hospital stay(From date of surgery until discharge, assessed upto 14 days)
- Postoperative Ileus(Upto 5 days post-operation)
- Surgical site infection(Up to 30 days post-operation)
研究者
Apoorva Mathur
Principal investigator, Junior Resident, Department of General Surgery
GSVM Medical College