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
Phase: NA
Conditions: Appendicitis
Sponsor: GSVM Medical College

STUDY PROTOCOL 
1. Title of the Study 
Clinical Profile of Appendicitis and Comparative Study of Harmonic Scalpel (Seal and Cut) 
Versus Suture Ligation of the Base of Appendix During Laparoscopic Appendectomy 
2. Protocol ID & Registration 
Protocol ID: GSVM/GENSURG/APP/2025 
ClinicalTrials.gov Identifier (NCT Number): [To be added] 
Trial Registration Registry: ClinicalTrials.gov 
3. Principal Investigator 
Name: Dr. Apoorva Mathur 
Designation: Principal Investigator 
Affiliation: Department of General Surgery, GSVM Medical College, Kanpur, India 
Email:apoorvamathur05@gmail.com 
Phone: 8484805719 
4. Research Guide / Senior Author 
Name: Dr. G.D Yadav 
Designation: Professor & Head 
Department: General Surgery, GSVM Medical College, Kanpur 
5. Background and Rationale 
Acute appendicitis is a common surgical emergency. Laparoscopic appendectomy is widely 
accepted, with secure closure of the appendix base being a critical step. The harmonic 
scalpel offers an energy-based alternative to traditional suturing. This study aims to 
compare outcomes between these two techniques. 
6. Study Objectives 
Primary Objective: 
- To compare operative time between harmonic scalpel and suture ligation techniques. 
 
Secondary Objectives: 
- To evaluate postoperative complications (leak, ileus, SSI) 
- To assess hospital stay duration 
- To document appendix position intraoperatively 
7. Study Design 
Study Type: Interventional (Clinical Trial) 
Allocation: Randomized (computer-based) 
Interventional Model: Parallel Assignment 

Masking: Single (Participant) 
Number of Arms: 2 
Primary Purpose: Treatment 
8. Participants 
Sample Size: 60 patients (30 per group) 
 
Inclusion Criteria: 
- Age 15–60 years 
- Diagnosed with uncomplicated acute appendicitis 
- Consent to participate 
 
Exclusion Criteria: 
- Perforated/gangrenous appendix 
- Pregnancy 
- Coagulopathy or severe comorbid illness 
9. Interventions 
Arm A: Harmonic Scalpel Group (Experimental) 
Laparoscopic appendectomy using harmonic scalpel to seal and divide appendix base. 
 
Arm B: Suture Ligation Group (Active Comparator) 
Laparoscopic appendectomy with intracorporeal suture ligation of appendix base. 
10. Outcome Measures 
Primary Outcome: 
- Operative time (in minutes) 
 
Secondary Outcomes: 
- Position of appendix (intraoperative) 
- Postoperative leak (within 7 days) 
- Postoperative ileus (within 3 days) 
- Surgical site infection (within 30 days) 
- Hospital stay (in days) 
11. Ethical Considerations 
Approved by Institutional Ethics Committee, GSVM Medical College 
Informed written consent will be obtained from all participants 
Trial will be registered with ClinicalTrials.gov 
12. Data Sharing Statement 
De-identified individual data will be shared upon request for secondary analysis after 6 
months of publication. 

13. Timeline 
Study Start: [April 2024] 
Estimated Completion: [e.g., july 2025] 
14. Funding and Support 
No external funding. Supported by institutional resources. 
 
Date- 01/05/2025