| CTRI Number |
CTRI/2023/04/051701 [Registered on: 18/04/2023] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
ICG dye study for gall bladder laparoscopic surgery |
|
Scientific Title of Study
|
‘A Prospective interventional comparative study of conventional laproscopic
cholecystectomy VERSUS Indocyanine green (ICG) dye used laproscopic
cholecystectomy in patients with gall stone disease in a tertiary care hospital’ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSantosh Thorat |
| Designation |
Associate Professor (General Surgery) |
| Affiliation |
PCMC PGI Yashwantrao Chavan Memorial Hospital |
| Address |
DEPT.OF SURGERY
ROOM NO 4
SECOND FLOOR
PCMC PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018
DEPT.OF SURGERY
ROOM NO 4
SECOND FLOOR
PCMC PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9665845948 |
| Fax |
|
| Email |
drsantosh308@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Thorat |
| Designation |
Associate Professor (General Surgery) |
| Affiliation |
PCMC PGI Yashwantrao Chavan Memorial Hospital |
| Address |
DEPT.OF SURGERY
ROOM NO 4
SECOND FLOOR
PCMC PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018
DEPT.OF SURGERY
ROOM NO 4
SECOND FLOOR
PCMC PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9665845948 |
| Fax |
|
| Email |
drsantosh308@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSantosh Thorat |
| Designation |
Associate Professor (General Surgery) |
| Affiliation |
PCMC PGI Yashwantrao Chavan Memorial Hospital |
| Address |
DEPT.OF SURGERY
ROOM NO 4
SECOND FLOOR
PCMC PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018
DEPT.OF SURGERY
ROOM NO 4
SECOND FLOOR
PCMC PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9665845948 |
| Fax |
|
| Email |
drsantosh308@gmail.com |
|
|
Source of Monetary or Material Support
|
| PCMC PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
DR SANTOSH THORAT |
| Address |
DEPT.OF SURGERY
ROOM NO 4
SECOND FLOOR
PCMC PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018 |
| 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 SANTOSH THORAT |
PCMC PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018 |
DEPT.OF SURGERY
ROOM NO 4
SECOND FLOOR
PCMC PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
9665845948
drsantosh308@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Yashwantrao chavan memorial hospital pimpri pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indocyanine green (ICG) dye LAP CHOLECYSTECTOMY |
Indocyanine green (ICG) dye used laproscopic cholecystectomy in patients with gall stone disease in a tertiary care hospital AT DAY ZERO the day of surgery
follow up at 3 weeks then follow up at 6 months |
| Comparator Agent |
NON ICG LAP CHOLECYSTECTOMY routine laparoscopic surgery or conventional laparoscopic surgery |
laparoscopic cholecystectomy in patients with gall stone disease in a tertiary care hospital on the day of surgery DAY ZERO then 3 weeks and then at 6 months follow up |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective laparoscopic surgery.
Patients of adult age of either sex.
Patients who are willing to participate with informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients with morbid obesity.
Patients allergic to ICG dye.
Patients hemodynamically unstable for surgery.
Patient not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| intra-operative BILE LEAK |
day of surgery day zero
post operative follow up at 3 weeks
then follow up at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
delayed Bile leak detection
anatomical variations seen due to ICG dye use |
SEEN AT 60 MINUTES POST ICG DYE INJECTION DURING SURGERY |
|
|
Target Sample Size
|
Total Sample Size="740"
Sample Size from India="740"
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 4 |
|
Date of First Enrollment (India)
|
18/04/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The laparoscopic approach has greatly improved patient care throughout various surgical subspecialties. Minimizing surgical trauma has a beneficial effect on patient recovery and decreases complications. Another advantage of laparoscopy is the improved surgical view. Not only due to improved monitors, magnification and 3d view, but more recently also through image guided techniques, such as fluorescent imaging. Indocyanine green (ICG)-enhanced fluorescence was introduced in laparoscopic surgery to improve the view and provide detailed anatomical information during surgery Primary Hypothesis :- There is an advantage of indocyanine green (INDOCYANINE GREEN DYE ) dye use in routine laproscopic surgery in the form of reduced rate of surgical complications due to identification of different anatomical variation and well defined visible tissue perfusion in patients undergoing indocyanine green (INDOCYANINE GREEN DYE ) dye enabled surgery. Secondary Research Question 1 :-( if any) to collect the data regarding anatomical variations seen during laproscopic surgeries by indocyanine green (INDOCYANINE GREEN DYE ) dye illuminations during surgeries of gall bladder. Primary Objectives :- To determine the effectiveness of laproscopic ICG dye used surgery during conventional laproscopic surgical practice in the form of reduced patient morbidity and mortality. DETAILED RESEARCH PLAN: A Prospective interventional comparative study will be conducted to understand incidence, presentation, operative methods and postoperative complication of various types of laparoscopic surgeries using ICG dye. Patients diagnosed and registered will be incorporated after written informed consent of the patient. The patient will be admitted and all routine investigation will be done as per preoperative requirements. Patients will be given standard medical and surgical treatment. The data collected and will be analyzed to reach an inference. |