| CTRI Number |
CTRI/2024/11/076339 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study about usage of Dye injection to asses any postoperative leak after surgically connecting bowel together |
|
Scientific Title of Study
|
A Study about comparison of IndoCyanineGreen(ICG) dye use in Colorectal surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venugopal |
| Designation |
Head of the department and senior consultant |
| Affiliation |
Lisie Hospital |
| Address |
Department of Surgical gastroenterology and liver transplantation
Lisie Hospital, North kaloor,
Cochin
-
Ernakulam
KERALA
682018
India |
| Phone |
8248149558 |
| Fax |
- |
| Email |
venugopal02@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venugopal |
| Designation |
Head of the department and senior consultant |
| Affiliation |
Lisie Hospital |
| Address |
Department of Surgical gastroenterology and liver transplantation
Lisie Hospital, North kaloor,
Cochin
-
Ernakulam
KERALA
682018
India |
| Phone |
9495142636 |
| Fax |
- |
| Email |
venugopal02@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR N Joshua |
| Designation |
DRNB SURGICAL GASTROENTEROLOGY RESIDENT |
| Affiliation |
Lisie Hospital |
| Address |
Department of Surgical gastroenterology and liver transplantation
Lisie Hospital,
North kaloor,
Cochin
Ernakulam
KERALA
682018
India |
| Phone |
8248149558 |
| Fax |
- |
| Email |
joshuanithian@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lisie Hospital |
| Address |
Lisie Hospital
Lisie Hospital road,
North Kaloor,
kochi
Ernakulam
COCHIN
682018 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 JOSHUA N |
Lisie Hospital |
Department of Surgical Gastroenterology
Lisie Hospital Road,
North Kaloor,
Ernakulam
Ernakulam
KERALA |
8248149558
joshuanithian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LISIE INSTITUTIONAL ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C188||Malignant neoplasm of overlappingsites of colon, (2) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (3) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indocyanine Green Dye (ICG) injection |
Patients in ICG group will be given the dye intraoperatively after resection of bowel to asses the proximal bowel edge and distal stump and also to look for vascularity after anasatamosis |
| Comparator Agent |
Standard surgery without the usage of ICG dye |
Non ICG Dye group patients will undergo anastomosis without intraopeartive ICG dye usage |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All laproscopically operable colorectal malignancies |
|
| ExclusionCriteria |
| Details |
Colorectal malignancies presenting with obstruction, perforation.
Colorectal malignancies with inoperable metastasis.
Recurrence
Redo Surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look for anastamotic leak |
On Postoperative day 1,3,5 & 7 & 2nd week & 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Look for any collection or abscess in CT abdomen & Pelvis
To look for lab parameters such as Hemoglobin Total WBC count,differential count, C-Reactive protein, Procalcitonin, S.albumin |
on POD 1,3,5,7, 2nd week & 4th week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
16/11/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
All laproscopically operable colorectal malignancies done in Lisie hospital for the period of 18 months Socioeconomic,clincal labortory data will be collected as per study proform Patients would be divided into ICG & Non ICG group based on the block randomization given by computer ICG groups will be given dye intraoperatively Non ICG group patients will be proceeded without udage of any dye Patients will be assesed on Post opeartive period . They will be classified into different grades based on clinical presentation
Lab parametrs such a s CRP, TC, DC, Albumin, Procalcitonin would be assesed on specific Post operative days & at the time of first visitr after discharge
CT Abdomen would be done on POD7 & on 4 weeks after surgery Results will be evaluated using SPSS software
|