Drain vs No Drain After Live Donor Hepatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-02

Study Completion Date

2026-02-28

Brief Summary

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Prophylactic abdominal drain placement after donor hepatectomy has been a common or even mandatory practice in most transplant centers. This serves to monitor the occurrence of post-operative intra-abdominal bleeding and is used for the detection and drainage of any bile leakage. However prophylactic drain placement is not without complications, like; Increased rates of intraabdominal and wound infection, Increased abdominal pain, Decreased pulmonary function, Bowel injury and Prolonged hospital stay. Comprehensive Complication Index (CCI) is a valuable tool used to assess the overall morbidity of patients after surgical interventions . The CCI score ranges from 0 (no complication) to 100 (death), reflecting the gravity of the overall complication burden on the patient on a continuous scale and is a validated tool for living donor liver transplants. The investigators aim to compare the safety of no drain placement vs abdominal drain placement in LDLT(Live Donor Liver Transplant) by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy.

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Detailed Description

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* This study will be a randomised controlled, pilot study to compare the safety of no drain placement vs abdominal drain placement in LDLT by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy.
* Patient admitted for donor hepatectomy will be recruited and further randomised into the Drain and No-Drain arms. Patients in the no drain arm will undergo routine steps in donor hepatectomy. After graft removal, hemostasis and biliostasis will be confirmed, following which abdomen will be closed in layers. For patients in the drain arm, same steps will be followed. At the end of the operation , additionally, 28 Fr abdominal drain will be inserted with tip near cut surface of remnant. Intraoperative and post-operative parameters will be compared between the groups. Comprehensive Complication index will be calculated on day of discharge using online universal CCI calculator application.

Conditions

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Donor Hepatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators aim to compare the safety of no drain placement vs abdominal drain placement in LDLT by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Trial will commence as soon as clearance from ethics committee is achieved. All voluntary healthy liver donors planned for donor hepatectomy, fulfilling inclusion criteria and not matching any of the exclusion criteria will be recruited . On the day of surgery, donor will be alloted either of the arms based on computer generated block randomization code.

Study Groups

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Drain

Patients in the drain arm will undergo routine steps in donor hepatectomy. After graft removal, hemostasis and biliostasis will be confirmed, following which at the end of the operation ,a 28 Fr abdominal drain will be inserted with tip near cut surface of remnant

Group Type NO_INTERVENTION

No interventions assigned to this group

No Drain

Patients in the no drain arm will undergo routine steps in donor hepatectomy. After graft removal, hemostasis and biliostasis will be confirmed, following which abdomen will be closed in layers. No intraabdominal drain will be placed.

Group Type EXPERIMENTAL

No Drain i.e. Omission of abdominal drain placement

Intervention Type OTHER

Omission of abdominal drain placement in intervention arm. The No-drain arm will be compared to drain arm

Interventions

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No Drain i.e. Omission of abdominal drain placement

Omission of abdominal drain placement in intervention arm. The No-drain arm will be compared to drain arm

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

Any patient not consenting to the procedure. Intraoperative need for drain placement in no drain arm due to surgical factors.

Inverted L/ J shaped incision. Laparoscopic donor hepatectomy Robotic donor hepatectomy.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No