Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy

"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

• Status: Completed
• Conditions: Liver Transplant
• Intervention / Treatment: Other: Drain Removal

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

1. Early detection of haemorrhage
2. Early detection of bile leak
3. 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

Study Locations

• India
  • Delhi, India, 110070
    • ILBS - Parthiban

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	Other: Drain Removal; 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	Other: Drain Removal; 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.	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	using Visual analogue score	patient will be followed upto 3 months after surgery
Bile leak	standard ISGLS definition - drain bilirubin measured in mg/dl.	patient will be followed upto 3 months after surgery
Length of hospital stay	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)	patient has at least one of the following: purulent drainage from the superficial incision.; organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)).; superficial incision that is deliberately opened by a surgeon, physician* or physician designee and culture or non-culture based testing of the superficial incision or subcutaneous tissue is not performed AND patient has at least one of the following signs or symptoms: localized pain or tenderness; localized swelling; erythema; or heat.; diagnosis of a superficial incisional SSI by a physician* or physician designee.	patient will be followed upto 3 months after surgery
reintervention rate	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	90 day readmission rate - any hospital admission after the index admission.	patient will be followed upto 3 months after surgery

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Publications and helpful links

Helpful Links

• Prospective Validation of Optimal Drain Management "The 3 × 3 Rule" after Liver Resection
• Living Donor Liver Transplantation for Acute Liver Failure: Donor Safety and Recipient Outcome
• Criteria for drain removal following liver resection

Study record dates

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