| CTRI Number |
CTRI/2025/05/086194 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Study of Harmonic Scalpel Versus Traditional Suture Ligation for Securing the Appendix Base During Laparoscopic Appendectomy |
|
Scientific Title of Study
|
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
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apoorva Mathur |
| Designation |
Junior Resident |
| Affiliation |
GSVM medical college and LLR hospital |
| Address |
Department of General Surgery, LLR hospital, GSVM Medical college, kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8384805719 |
| Fax |
|
| Email |
apoorvamathur05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GD Yadav |
| Designation |
Professor, Head of department, department of surgery, GSVM kanpur |
| Affiliation |
GSVM medical college and LLR hospital |
| Address |
Department of General Surgery, LLR hospital, GSVM medical college, kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415092218 |
| Fax |
|
| Email |
yadavgd71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Apoorva Mathur |
| Designation |
Junior Resident |
| Affiliation |
GSVM medical college and LLR hospital |
| Address |
Department of General Surgery, LLR hospital, GSVM Medical college, kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8384805719 |
| Fax |
|
| Email |
apoorvamathur05@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSVM Medical college and LLR hospital, kanpur, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Department of General Surgery |
| Address |
GSVM kanpur
Swaroop nagar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apoorva Mathur |
GSVM Medical college and LLR hospital |
Surgery wards, department of General Surgery
Kanpur Nagar
UTTAR PRADESH |
8384805719
apoorvamathur05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee( For Biomedical Health and Research), GSVM Medical College, kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Harmonic Scalpel |
Surgical instrument
Ultrasonic energy based device used for sealing as well as cutting the base of appendix. |
| Comparator Agent |
Traditional Suture ligation of base of appendix. |
Using Absorbable sutures for ligating base of appendix. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing for laparoscopic appendicectomy |
|
| ExclusionCriteria |
| Details |
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
Diagnostic criteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Position of Appendix
Operative time
Postoperative leak
Postoperative ileus
Surgical site infection
Hospital Stay |
Intraoperative
Postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recovery
Postoperative complications |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |