| CTRI Number |
CTRI/2023/05/052531 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess metal clips usage in laparoscopic gall bladder removal surgery |
|
Scientific Title of Study
|
A Prospective, Single-blind, Randomized, Multi centre, study to assess the clinical equivalence of Trutie® Ligating clips to Ligaclip® ligating clips in laparoscopic cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IND-HEALTHIUM-TRUTIE-2023-16, Version -1, 27 February 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Limited |
| Address |
Healthium Medtech
472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Peenya,
Bengaluru, Karnataka
Bangalore KARNATAKA 560058 India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Limited |
| Address |
Healthium Medtech
472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Peenya,
Bengaluru, Karnataka
KARNATAKA 560058 India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Limited |
| Address |
Healthium Medtech
472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Peenya,
Bengaluru, Karnataka
KARNATAKA 560058 India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
|
Source of Monetary or Material Support
|
| Healthium Medtech
472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Peenya,
Bengaluru, Karnataka 560058 |
|
|
Primary Sponsor
|
| Name |
Healthium Medtech Limited |
| Address |
Healthium Medtech
472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Peenya,
Bengaluru, Karnataka 560058 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srikanth Kulkarni |
BGS Global Institute of Medical Sciences |
Ground Floor OPD, No 67
BGS Health and Education City
Uttarahalli Road Kengeri Bangalore KARNATAKA |
9980218989
drsrikanthbgsresearch@gmail.com |
| Dr Sanjay Kala |
GSVM Medical college |
Principal Room Department of General Surgery
Swaroop Nagar
Kanpur Nagar UTTAR PRADESH |
9939210012
surgerygsvmmc@gmail.com |
| Dr Seraj Ahmed |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Ronald Ross Building, 6th Floor, Department of General Surgery, 244 AJC Bose Road
Kolkata WEST BENGAL |
9830425786
seraj1211@gmail.com |
| Dr Prashant V Rahate |
Seven Star Hospital |
OPD no 4, Ground Floor, Jagnade Square, Great Nag Road, Nandanwan Nagpur MAHARASHTRA |
9822464068
prashantrahate84@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College Kanpur |
Approved |
| Ethics Committee Rahate Surgical Hospital |
Approved |
| Institutional Ethics Committee |
Approved |
| IPGME and R Resaerch Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LIGACLIP Ligating clips |
Ligaclip ligating clips are used for ligation of tubular structure or vessels where a non-absorbable ligating clip is indicated. Once applied will not be removed from the body. |
| Intervention |
TRUTIE Ligating clips |
Trutie ligating clips are used for ligation of tubular structure or vessels where a non-absorbable ligating clip is indicated. Once applied will not be removed from the body. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female patients aged between 18 to 60 years
2. Subjects scheduled for elective laparoscopic cholecystectomy surgery
3. Subjects willing to give written informed consent and willing to comply with all study requirements |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of pancreatitis
2. Subjects with suspicion of gallbladder carcinoma or other metastatic diseases
3. Subjects who are pregnant or lactating at the time of surgery
4. Subjects with coagulation disorder
5. Subjects intraoperatively found to have with modified Nassar difficulty grading scale 3 4 and 5
6. Subjects whose surgical approach got converted from laparoscopic to open surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the incidence of bile leakage and bleeding after closure of cystic duct and cystic artery in both groups |
Day of surgery, Day of discharge, Day 10 post surgery, Day 30 post surgery, Day 180 post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of intra and post operative complications adverse device reactions and adverse events from day of surgery to 6 months post operatively |
Day of surgery Day of discharge Day 10 post surgery Day 30 post surgery Day 180 post surgery |
Time taken from initial incision to closure of wound
|
Day of surgery |
| Number of clips used to ligate cystic duct and artery |
Day of surgery |
| Assessment of intraoperative handling of clips between the two groups using 5 point scale and Assessment of number of clip breakage failure to ligate and malformed or deformed clips |
Day of surgery |
| Postoperative length of hospital stay in both the groups |
Day of discharge |
| To assess the incidence of residual risks of ligating clips |
Day of surgery Day of discharge Day 10 post surgery Day 30 post surgery Day 180 post surgery |
| To assess the time to recovery as measured by return to the normal day to day activities |
Day 10 post surgery Day 30 post surgery Day 180 post surgery |
| To evaluate the quality of life using the Otago gallstones condition specific questionnaire |
Baseline visit Day 30 post surgery Day 180 post surgery |
|
|
Target Sample Size
|
Total Sample Size="132" Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study aims to establish clinical equivalence of Trutie® Ligating clips (Healthium Medtech Limited) to Ligaclip® ligating clips (Ethicon) in laparoscopic cholecystectomy and generate additional evidence on usage of Titanium metal ligating clips. The use of surgical clips is crucial in laparoscopic surgery/ cholecystectomy. Titanium ligating clips are a type of non-absorbable clip that are commonly used in laparoscopic cholecystectomy procedures to secure the cystic duct and cystic artery during gallbladder removal. These clips are made of a lightweight, durable metal and are designed to provide a secure and permanent closure of the ducts. In current study we plan to assess the clinical equivalence of both devices via incidence of bile leakage and bleeding after closure of cystic duct and cystic artery, assessment of intra and post-operative complications, adverse device reactions, and adverse events from day of surgery to 6 months post-operatively, time taken from initial incision to closure of wound, intraoperative handling of clips and clip applicator between the two groups using 5-point scale, number of clip breakage, failure to ligate, and malformed or deformed clips, Postoperative length of hospital stay, incidence of residual risks of ligating clips, time to recovery as measured by return to the normal day to day activities and quality of life using the Otago gallstones condition specific questionnaire. Clinical data obtained by this study will add value to the user’s decision to choose the titanium ligating clip in various surgeries. |