NCT07049965

Comparative Study of Harmonic Scalpel vs. Suture Ligation for Appendix Base During Laparoscopic Appendectomy

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: GSVM Medical College · Academic / Other
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Appendicitis

Interventions

Type	Name	Description
PROCEDURE	Suture ligation	Participants will undergo laparoscopic appendectomy in which the base of the appendix is ligated using intracorporeal suturing with absorbable material. This is the conventional technique used to prevent stump leakage.
DEVICE	Harmonic Scalpel	Participants will undergo laparoscopic appendectomy where the base of the appendix is sealed and divided using the harmonic scalpel. This ultrasonic energy-based device cuts and coagulates tissue simultaneously, potentially reducing operative time and blood loss.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-06-30
• Completion: 2025-08-15
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated device study