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

NCT ID: NCT07049965

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-08-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Suture ligation

Participants will undergo laparoscopic appendectomy where the base of the appendix is secured using conventional intracorporeal suture ligation, using absorbable sutures.

Group Type: ACTIVE_COMPARATOR

Suture ligation

Intervention Type: PROCEDURE

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.

Harmonic Scalpel

Participants in this group will undergo laparoscopic appendectomy in which the base of the appendix is sealed and divided using a harmonic scalpel. The device simultaneously cuts and coagulates tissue using ultrasonic energy, potentially reducing operative time, blood loss, and thermal injury compared to conventional methods.

Group Type: EXPERIMENTAL

Harmonic Scalpel

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 5 - 65 years

2. Any gender

3. Patient willing to undergo laparoscopic appendectomy

4. Acute appendicitis confirmed by clinical and radiological analysis

5. Alvarado Score ≥7

6. Alvarado Score ≥5 with positive ultrasound findings

Exclusion Criteria

1. Patient with base of appendix highly inflamed / gangrenous

2. 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.

3. Patients declared unfit for laparoscopic surgery during preoperative assessment

4. Patients having severe co morbid condition - COPD/CAD/CHF

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GSVM Medical College

OTHER

Sponsor Role: lead

Responsible Party

Apoorva Mathur

Principal investigator, Junior Resident, Department of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Apoorva Mathur, MBBS

Role: PRINCIPAL_INVESTIGATOR

Ganesh Shankar Vidhyarthi Memorial Medical College Kanpur

Locations

Ganesh Shankar Vidhyarthi Memorial Medical College Kanpur

Kanpur, Uttar Pradesh, India

Countries

India

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

EC/BMHR/2024/35

Identifier Type: -

Identifier Source: org_study_id