Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Liver Transplant

Treatments: Other: Drain Removal

Study type: Interventional

Funder types: Other

Identifiers

NCT04504487

ILBS/LIVEDONORS/01

Details and patient eligibility

About

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.

Full 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

4. 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.

Enrollment: 108 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups, including a placebo group

Early drain removal - POD3

Experimental group

Description:

Drain removal on POD3 if drain bilirubin is less than 3mg/dl and serous in nature.

Treatment:

Other: Drain Removal

Routine Drain Removal

Placebo Comparator group

Description:

Drain removed routinely when the output is less than 100ml and serous in nature

Treatment:

Other: Drain Removal