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

NCT07049965 | Active Not Recruiting FDA Device

• 1 other identifier: EC/BMHR/2024/35
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis

Keywords

Laparoscopic appendicectomy; Harmonic scalpel; Suture ligation; Surgical site infection; Operative time; Appendicitis; Appendiceal stump closure

Outcome Measures

Primary Outcomes (1)

• Operative time

  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.

  Intraoperative( measured during surgical procedure on day 1)

Secondary Outcomes (5)

• Position of appendix

  Intraoperative ( day 1)

• Postoperative Leak

  Upto 7 days post-operation

• Postoperative Ileus

  Upto 5 days post-operation

• Surgical site infection

  Up to 30 days post-operation

• Hospital stay

  From date of surgery until discharge, assessed upto 14 days

Study Arms (2)

Suture ligation

ACTIVE COMPARATOR

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

Procedure: Suture ligation

Harmonic Scalpel

EXPERIMENTAL

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.

Device: Harmonic Scalpel

Interventions

Suture ligation 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.

Suture ligation

Harmonic Scalpel 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.

Harmonic Scalpel

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Any gender
• Patient willing to undergo laparoscopic appendectomy
• Acute appendicitis confirmed by clinical and radiological analysis
• Alvarado Score ≥7
• Alvarado Score ≥5 with positive ultrasound findings

You may not qualify if:

• 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

Sponsors & Collaborators

• GSVM Medical College: lead

Study Sites (1)

Ganesh Shankar Vidhyarthi Memorial Medical College Kanpur

Kanpur, Uttar Pradesh, 208002, India

Location

MeSH Terms

Conditions

Appendicitis; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Apoorva Mathur, MBBS

  Ganesh Shankar Vidhyarthi Memorial Medical College Kanpur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Junior Resident, Department of General Surgery

Model Details: Randomized, Parallel Group, Active controlled trial Computer generated randomisation

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 3, 2025
• Study Start: April 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 15, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication of results for 2 years
• Access Criteria: Qualified researchers upon reasonable request

Locations

IN (1)