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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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