Drain vs No Drain After Live Donor Hepatectomy

NCT06769776 | Recruiting DMC

• 1 other identifier: MAHF/AP/LTP-1/EC/2024/04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Donor Hepatectomy

Outcome Measures

Primary Outcomes (1)

• CCI index on post operative day 7

  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 by comparing the comprehensive complication index(CCI) between both arms on post operative day 7 after donor hepatectomy.

  Admission one day prior to live donor hepatectomy till post operative day 7.

Secondary Outcomes (6)

• Infective complications

  Admission one day prior to live donor hepatectomy till post operative day 7

• Duration of hospital stay

  Admission one day prior to live donor hepatectomy till post operative day 7

• Paralytic ileus

  Admission one day prior to live donor hepatectomy till post operative day 7.

• Bile leak

  Admission one day prior to live donor hepatectomy till post operative day 7

• Hemorrhage

  Admission one day prior to live donor hepatectomy till post operative day 7

Study Arms (2)

Drain

NO INTERVENTION

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

No Drain

EXPERIMENTAL

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.

Other: No Drain i.e. Omission of abdominal drain placement

Interventions

No Drain i.e. Omission of abdominal drain placement OTHER

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

No Drain

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marengo Asia Hospitals: lead

Study Sites (1)

Marengo Asia Hospitals

Faridabad, Haryana, 121002, India

RECRUITING

Study Officials

• Punit Singla, MS,DNB

  Marengo Asia Hospitals

  STUDY DIRECTOR

Central Study Contacts

Bharat Nair, MCh

CONTACT

08373926785; bharatarcher1@gmail.com

Priyanka Tripathi

CONTACT

9873440277; Priyanka.Tripathi@marengoasia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator. Consultant , Department of HPB surgery and liver Transplant

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: January 10, 2025
• Study Start: August 2, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)