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NCT Number: NCT06769776

Drain vs No Drain After Live Donor Hepatectomy

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.

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Key information

Conditions

Donor Hepatectomy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

No Drain i.e. Omission of abdominal drain placement

Other

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

Primary outcomes

  1. CCI index on post operative day 7

    Time frame: 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 outcomes

  1. Infective complications

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

    Surgical site infections, intra abdominal abscesses

  2. Duration of hospital stay

    Time frame: 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

  3. Paralytic ileus

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

    Days to start normal oral diet after surgery

  4. Bile leak

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

    Occurrence and detection of bile leak after donor hepatectomy

  5. Hemorrhage

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

    Occurrence and detection of bleeding after live donor hepatectomy

  6. Post operative pain scores

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bharat Nair, MCh

CONTACT

[email protected]

08373926785

Priyanka Tripathi

CONTACT

[email protected]

9873440277

Sponsors and collaborators

Lead sponsor

Marengo Asia Hospitals

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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