CTRI Number |
CTRI/2021/01/030702 [Registered on: 22/01/2021] Trial Registered Prospectively |
Last Modified On: |
20/01/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Early Versus Routine Abdominal Drain Removal After Live Liver Donor
Hepatectomy |
Scientific Title of Study
|
“Early Versus Routine Drain Removal After Live Liver Donor
Hepatectomy- A Randomized Controlled, open label, Pilot study†|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
PARTHIBAN |
Designation |
Senior Resident |
Affiliation |
Institute of Liver and Biliary Sciences |
Address |
ILBS
Vasanth Kunj
Delhi I New Delhi DELHI 110070 India |
Phone |
7010752115 |
Fax |
|
Email |
parthid2005@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
viniyendra pamecha |
Designation |
Professor |
Affiliation |
Institute of Liver and Biliary Sciences |
Address |
HPB and Liver transplant department
ILBS
Vasanth Kunj
Delhi
New Delhi DELHI 110070 India |
Phone |
95409546803 |
Fax |
|
Email |
viniyendra@yahoo.co.uk |
|
Details of Contact Person Public Query
|
Name |
PARTHIBAN |
Designation |
Senior Resident |
Affiliation |
Institute of Liver and Biliary Sciences |
Address |
ILBS
Vasanth Kunj
Delhi
New Delhi DELHI 110070 India |
Phone |
7010752115 |
Fax |
|
Email |
parthid2005@gmail.com |
|
Source of Monetary or Material Support
|
Institute of Liver and biliary Sciences,
Vasanth Kunj D1
New Delhi
110070 |
|
Primary Sponsor
|
Name |
ILBS |
Address |
ILBS
Vasanth Kunj
Delhi |
Type of Sponsor |
Research institution and hospital |
|
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 |
Parthiban |
institute of liver and biliary sciences |
room no 3016
Dept of HPB surgery and liver transplant
ILBS
Vasanth kunj
New Delhi New Delhi DELHI |
7010752115
parthid2005@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Communication of Decision of the Institutional Ethics Committee (IEC) / Institutional Review Board (IRB) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Live Liver Donors undergoing surgery |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Early drain removal |
removal of abdominal drain on POD 3 |
Comparator Agent |
Routine drain removal |
routine drain removal, when the output is serous and less than 100ml |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
live donor undergoing donor hepatectomy |
|
ExclusionCriteria |
Details |
left lateral hepatectomy |
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
safety of early drain removal
complications compared between both group using CCI. |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
bile leak |
3 months |
bowel injury |
3 months |
post operative pain score |
30 days |
post op hospital stay |
15 days |
readmission and reintervention rate |
30 days |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 2/ Phase 3 |
Date of First Enrollment (India)
|
28/01/2021 |
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
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Prophylactic
abdominal drainage after donor right hepatectomy for LDLT has been a common or
even mandatory practice in most transplant centres. This serves to monitor the
occurrence of postoperative intra abdominal bleeding and is used for the
detection and drainage of any bile leakage. However drain placement is not
without any disadvantages like infective complications, increased pain, and
prolonged hospital stay and bowel injury. In a study on non transplant liver
resections by mitsuka et al, they validated 3x3 rule and concluded that the
rule is clinically feasible and
allows for the early removal of the drain tube with minimum infection risk
after liver resection. There is no study done on live donor liver resection, in
terms of drain removal. We are doing a randomized control trial to
compare the safety of early drain removal versus standard drain removal after
donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate
the safety of early drain removal using 3x3 rule with routine drain removal. |