Drain vs No Drain After Live Donor Hepatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Drain i.e. Omission of abdominal drain placement.
- Who it may be relevant to
- Registry conditions: Donor Hepatectomy. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Drain Versus No-Drain After Live Donor Hepatectomy- A Randomized Controlled, Pilot Study
Overview
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.
Interventions
- Other 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
Primary outcome measures
- CCI index on post operative day 7 [Time frame: Admission one day prior to live donor hepatectomy till post operative day 7.]
Secondary outcome measures (6)
- Infective complications [Time frame: Admission one day prior to live donor hepatectomy till post operative day 7]
- Duration of hospital stay [Time frame: Admission one day prior to live donor hepatectomy till post operative day 7]
- Paralytic ileus [Time frame: Admission one day prior to live donor hepatectomy till post operative day 7.]
- Bile leak [Time frame: Admission one day prior to live donor hepatectomy till post operative day 7]
- Hemorrhage [Time frame: Admission one day prior to live donor hepatectomy till post operative day 7]
- Post operative pain scores [Time frame: Admission one day prior to live donor hepatectomy till post operative day 7]
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
India · 1 center
- Marengo Asia Hospitals — Faridabad
Identifiers
NCT: NCT06769776 · MAHF/AP/LTP-1/EC/2024/04