Drain vs No Drain After Live Donor Hepatectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMarengo Asia Hospitals

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: DrainNo intervention 0 interventions
Group B: No DrainExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Infective complications

Surgical site infections, intra abdominal abscesses

Time frame
Admission one day prior to live donor hepatectomy till post operative day 7
2

Duration of hospital stay

Total days of hospitalization required from admission till post operative day 7

Time frame
Admission one day prior to live donor hepatectomy till post operative day 7
3

Paralytic ileus

Days to start normal oral diet after surgery

Time frame
Admission one day prior to live donor hepatectomy till post operative day 7.
4

Bile leak

Occurrence and detection of bile leak after donor hepatectomy

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.