Clinical trial NCT06769776: Drain vs No Drain After Live Donor Hepatectomy
Official title: Drain Versus No-Drain After Live Donor Hepatectomy- A Randomized Controlled, Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Donor Hepatectomy
Lead sponsor: Marengo Asia Hospitals
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: CCI index on post operative day 7
timeFrame: Admission one day prior to live donor hepatectomy till post operative day 7.
Secondary outcomes:
measure: Infective complications
timeFrame: Admission one day prior to live donor hepatectomy till post operative day 7
measure: Duration of hospital stay
timeFrame: Admission one day prior to live donor hepatectomy till post operative day 7
measure: Paralytic ileus
timeFrame: Admission one day prior to live donor hepatectomy till post operative day 7.
measure: Bile leak
timeFrame: Admission one day prior to live donor hepatectomy till post operative day 7
measure: Hemorrhage
timeFrame: Admission one day prior to live donor hepatectomy till post operative day 7
measure: Post operative pain scores
timeFrame: Admission one day prior to live donor hepatectomy till post operative day 7
Other outcomes:
Locations:
city: Faridabad
country: India
facility: Marengo Asia Hospitals
state: Haryana
Study officials:
affiliation: Marengo Asia Hospitals
name: Punit Singla, MS,DNB
role: STUDY_DIRECTOR
References: