Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study.

Conditions
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Liver Transplant

Intervention / Treatment
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* Other: Drain Removal


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early drain removal - POD3<br>Drain removal on POD3 if drain bilirubin is less than 3mg/dl and serous in nature. | Other: Drain Removal<br>* Abdominal drain placed during surgery removal<br>|
| Placebo Comparator: Routine Drain Removal<br>Drain removed routinely when the output is less than 100ml and serous in nature | Other: Drain Removal<br>* Abdominal drain placed during surgery removal<br>|

What is the study measuring?
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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 |