- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04504487
Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy
May 9, 2022 updated by: Institute of Liver and Biliary Sciences, India
"Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study".
It's a randomized control trial to compare 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.
Study Overview
Detailed Description
- 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 intraabdominal bleeding and is used for the detection and drainage of any bile leakage.
- Below table mentions both advantages and disadvantages of prophylactic drain placement after hepatectomy.
Advantages
- Early detection of haemorrhage
- Early detection of bile leak
- Early reintervention Disadvantages
1. Increased rates of intraabdominal and wound infection, 2. Increased abdominal pain, 3. Decreased pulmonary function, 4. Prolonged hospital stay, 5. Bowel injury.
- Our study in ILBS for ALF donors, the overall complication rate was 20% as per Clavien-Dindo classification, of which a majority (15.9%) had grade 1 or 2 complications. Major complications (3b and above) were seen in 4 (1.0%) patients. Biliary complications were noted in 1.7% only.
- In a study by Japanese group concluded that 3 × 3 rule is clinically feasible and allows for the early removal of the drain tube with minimum infection risk after liver resection. The ''3 x 3 rule'': the drain will be removed when the drain fluid bilirubin concentration is <3 mg/dl on day 3 after operation.
- In our institute we remove drain routinely, when output is less than 100ml and serous. That is usually on postoperative day 5-7.
- There is no randomized control trail done in donor hepatectomy comparing early versus standard drain removal.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Delhi, India, 110070
- ILBS - Parthiban
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Donors evaluated as per institutional protocol for donor hepatectomy and found fit
- Those who consent
Exclusion Criteria:
- Patients refusing to consent for inclusion in the study.
- Left lateral hepatectomy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early drain removal - POD3
Drain removal on POD3 if drain bilirubin is less than 3mg/dl and serous in nature.
|
Abdominal drain placed during surgery removal
|
Placebo Comparator: Routine Drain Removal
Drain removed routinely when the output is less than 100ml and serous in nature
|
Abdominal drain placed during surgery removal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety of drain removal using 3x3 rule - overall complications.
Time Frame: patient will be followed upto 3 months after surgery
|
Comprehensive complication index (CCI) - clavin dindo classification
|
patient will be followed upto 3 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post operative pain relief
Time Frame: patient will be followed upto 3 months after surgery
|
using Visual analogue score
|
patient will be followed upto 3 months after surgery
|
Bile leak
Time Frame: patient will be followed upto 3 months after surgery
|
standard ISGLS definition - drain bilirubin measured in mg/dl.
|
patient will be followed upto 3 months after surgery
|
Length of hospital stay
Time Frame: patient will be followed upto 3 months after surgery
|
calculated from the day of admission to day of discharge, and based on the number of nights spent in hospital
|
patient will be followed upto 3 months after surgery
|
Surgical Site Infection (SSI)
Time Frame: patient will be followed upto 3 months after surgery
|
patient has at least one of the following:
|
patient will be followed upto 3 months after surgery
|
reintervention rate
Time Frame: patient will be followed upto 3 months after surgery
|
defined as any additional abdominal intervention ( surgical or radiological) during the same hospital stay after the primary operation
|
patient will be followed upto 3 months after surgery
|
readmission rate
Time Frame: patient will be followed upto 3 months after surgery
|
90 day readmission rate - any hospital admission after the index admission.
|
patient will be followed upto 3 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2021
Primary Completion (Actual)
February 25, 2022
Study Completion (Actual)
February 25, 2022
Study Registration Dates
First Submitted
July 30, 2020
First Submitted That Met QC Criteria
August 5, 2020
First Posted (Actual)
August 7, 2020
Study Record Updates
Last Update Posted (Actual)
May 13, 2022
Last Update Submitted That Met QC Criteria
May 9, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- ILBS/LIVEDONORS/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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