Drain Versus No-Drain After Live Donor Hepatectomy- A Randomized Controlled, Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
Locations
Other Locations
India
Marengo Asia Hospitals
RECRUITING
Faridabad
Contact Information
Primary
Bharat Nair, MCh
bharatarcher1@gmail.com
08373926785
Backup
Priyanka Tripathi
Priyanka.Tripathi@marengoasia.com
9873440277
Time Frame
Start Date: 2024-08-02
Estimated Completion Date: 2025-06
Participants
Target number of participants: 80
Treatments
No_intervention: 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
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Marengo Asia Hospitals

This content was sourced from clinicaltrials.gov