Drain vs No Drain After Live Donor Hepatectomy

Not Applicable

Recruiting

• Conditions: Donor Hepatectomy

• Registration Number: NCT06769776
• Lead Sponsor: Marengo Asia Hospitals

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.

Detailed Description

* 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.

Study Timeline

• Study Start: 2024-08-02
• Study First Submitted: 2024-08-05
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients undergoing donor hepatectomy -

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CCI index on post operative day 7	Admission one day prior to live donor hepatectomy till 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.

Secondary Outcome Measures

Name	Time	Method
Paralytic ileus	Admission one day prior to live donor hepatectomy till post operative day 7.	Days to start normal oral diet after surgery
Infective complications	Admission one day prior to live donor hepatectomy till post operative day 7	Surgical site infections, intra abdominal abscesses
Duration of hospital stay	Admission one day prior to live donor hepatectomy till post operative day 7	Total days of hospitalization required from admission till post operative day 7
Bile leak	Admission one day prior to live donor hepatectomy till post operative day 7	Occurrence and detection of bile leak after donor hepatectomy
Hemorrhage	Admission one day prior to live donor hepatectomy till post operative day 7	Occurrence and detection of bleeding after live donor hepatectomy
Post operative pain scores	Admission one day prior to live donor hepatectomy till post operative day 7	Post operative pain as measured by twice daily (Visual Analogue Scale)VAS scores

Trial Locations

Locations (1)

Marengo Asia Hospitals; 🇮🇳 Faridabad, Haryana, India