| CTRI Number |
CTRI/2025/12/098989 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Consecutive Sampling |
| Study Design |
Other |
|
Public Title of Study
|
To compare electrocautery and ultrasonic dissector in gallbladder dissection of laparoscopic cholecystectomy in terms of operative time, blood loss and postoperative complications |
|
Scientific Title of Study
|
Comparative study of monopolar electrocautery versus ultrasonic dissection of gallbladder in laparoscopic cholecystectomy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KSHETRIMAYUM ROMANCE SINGH |
| Designation |
PGT of General Surgery |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
RIMS INTERNS HOSTEL, ROOM NO 109, LAMPHELPAT, IMPHAL WEST
Imphal West
MANIPUR
795004
India |
| Phone |
7005749270 |
| Fax |
|
| Email |
romancekshetri003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROFESSOR SUNILKUMAR SINGH SALAM |
| Designation |
PROFESSOR, DEPARTMENT OF SURGERY |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
SURGERY DEPARTMENT, ROOM NO. 3.
Imphal West
MANIPUR
795004
India |
| Phone |
7005816984 |
| Fax |
|
| Email |
shoenil24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KSHETRIMAYUM ROMANCE SINGH |
| Designation |
PGT of General Surgery |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
RIMS INTERNS HOSTEL, ROOM NO. 109
Imphal West
MANIPUR
795004
India |
| Phone |
7005749270 |
| Fax |
|
| Email |
romancekshetri003@gmail.com |
|
|
Source of Monetary or Material Support
|
| REGIONAL INSTITUTE OF MEDICAL SCIENCES, LAMPHELPAT, IMPHAL, 795004, IMPHAL WEST, MANIPUR |
|
|
Primary Sponsor
|
| Name |
DR KSHETRIMAYUM ROMANCE SINGH |
| Address |
RIMS INTERNS HOSTEL, ROOM NO. 109, LAMPHELPAT, 795004, IMPHAL WEST, MANIPUR |
| Type of Sponsor |
Other [Self ] |
|
|
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 KSHETRIMAYUM ROMANCE SINGH |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
LAMPHELPAT, IMPHAL, 795004
Thoubal
MANIPUR |
07005749270
romancekshetri003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with cholelithiasis admitted for laparoscopic cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Acute or gangrenous cholecystitis, gallbladder malignancy, coagulopathies or bleeding disorders, patient with jaundice, use of instruments other than the intended dissector instruments, conversion to open surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Operative time, intraoperative blood loss, gallbladder perforation rate, postoperative pain scores |
2years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/12/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 prospective observational study evaluating the effectiveness and safety between surgeries performed using electrocautery and those performed using the curved jaw cordless ultrasonic dissector during laparoscopic cholecystectomy. Patient will be selected through consecutive sampling as they present for surgery and meet inclusion criteria. The choice of instrument will be based on availability and surgeon preference without any predefined allocation. The primary outcome measures include: operative time, intraoperative blood loss, gallbladder perforation rate, postoperative pain scores, postoperative complications. Data will be statistically analysed using appropriate tests, and the results will help determine whether the curved jaw cordless ultrasonic dissector offers significant clinical advantages over traditional electrocautery in terms of effectiveness, safety and patient outcomes. |