| CTRI Number |
CTRI/2024/01/061311 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparison of the use of two instruments - electric cautery and ultrasonic shearer in Laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Comparison of the use of electrocautery and ultrasonic shearer in Laparoscopic cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jenikali Phucho |
| Designation |
RESIDENT DOCTOR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
General surgery department
Sir T Hospital Bhavnagar
Jail Road Bhavnagar
Bhavnagar
Gujarat
DEPARTMENT OF GENERAL SURGERY
SIR T HOSPITAL
Bhavnagar
GUJARAT
364001
India |
| Phone |
9612292640 |
| Fax |
|
| Email |
jenip95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samir M Shah |
| Designation |
PROFESSOR & HEAD OF DEPARTMENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
DEPARTMENT OF GENERAL SURGERY
SIR T HOSPITAL BHAVNAGAR
JAIL ROAD
BHAVNAGAR
DEPARTMENT OF GENERAL SURGERY
SIR T HOSPITAL
BHAVNAGAR
GUJARAT
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215253 |
| Fax |
|
| Email |
shah.samir1570@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jenikali Phucho |
| Designation |
RESIDENT DOCTOR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
DEPARTMENT OF GENERAL SURGERY
SIR T HOSPITAL
JAIL ROAD BHAVNAGAR
GUJARAT
DEPARTMENT OF GENERAL SURGERY
SIR T HOSPITAL
Bhavnagar
GUJARAT
364001
India |
| Phone |
9612292640 |
| Fax |
|
| Email |
jenip95@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE AND SIR T HOSPITAL, BHAVNAGAR, GUJARAT |
|
|
Primary Sponsor
|
| Name |
SIR T HOSPITAL BHAVNAGAR |
| Address |
Department of General Surgery Sir T Hospital
Government medical College
Bhavnagar |
| 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 |
| Jenikali Phucho |
Surgery IPD Department of General Surgery |
Surgery Department of General Surgery
Sir T Hospital and Government medical College Bhavnagar
Bhavnagar
GUJARAT |
9612292640
jenip95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Government medical college, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Electrocautery |
Electrocautery for cutting and cauterising tissue and vessels in Laparoscopic cholecystectomy |
| Intervention |
Ultrasonic device |
Ultrasonic device for cutting and cauterising tissue and vessels in Laparoscopic cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of gall bladder disease undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Liver cirrhosis
Bleeding disorders
Pregnancy |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess complications of electrocautery And ultrasonic device in Laparoscopic cholecystectomy |
At the end of 15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To note & record operative time
To evaluate hospital stay and time taken for recovery in both devices
|
At the end of 15 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2024 |
| 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="1"
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
|
Laparoscopic cholecystectomy is the gold standard operation for benign gallbladder stone diseases. Till early 2000s, Monopolar cautery has been the most commonly used energy device to dissect and coagulate tissue while performing laparoscopic procedures, also widely used in Laparoscopic cholecystectomy Electrocautery being more intensely heat generating, is being associated with thermal injuries locally and to distant structures, excessive smoke production, arcing with metallic sleeve and/or port. Ultrasonic dissector, introduced in 1992, is increasingly being used and suggested as alternatives to electrocautery in Laparoscopic cholecystectomy this study is to assess and compare electrocautery and ultrasonic device in laparoscopic cholecystectomy
|