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Completed

NCT Number: NCT04504487

Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy

It's a randomized control trial to compare early drain removal versus standard drain removal after donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate the safety of early drain removal using 3x3 rule with routine drain removal.

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Key information

Conditions

Liver Transplant

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ILBS - Parthiban

Delhi, 110070, India

About this study

  • Prophylactic abdominal drainage after donor right hepatectomy for LDLT has been a common or even mandatory practice in most transplant centres.
  • This serves to monitor the occurrence of postoperative intraabdominal bleeding and is used for the detection and drainage of any bile leakage.
  • Below table mentions both advantages and disadvantages of prophylactic drain placement after hepatectomy.

Advantages

  • Early detection of haemorrhage
  • Early detection of bile leak
  • Early reintervention Disadvantages
  • Increased rates of intraabdominal and wound infection, 2. Increased abdominal pain, 3. Decreased pulmonary function, 4. Prolonged hospital stay, 5. Bowel injury.
  • Our study in ILBS for ALF donors, the overall complication rate was 20% as per Clavien-Dindo classification, of which a majority (15.9%) had grade 1 or 2 complications. Major complications (3b and above) were seen in 4 (1.0%) patients. Biliary complications were noted in 1.7% only.
  • In a study by Japanese group concluded that 3 × 3 rule is clinically feasible and allows for the early removal of the drain tube with minimum infection risk after liver resection. The ''3 x 3 rule'': the drain will be removed when the drain fluid bilirubin concentration is <3 mg/dl on day 3 after operation.
  • In our institute we remove drain routinely, when output is less than 100ml and serous. That is usually on postoperative day 5-7.
  • There is no randomized control trail done in donor hepatectomy comparing early versus standard drain removal.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • • Donors evaluated as per institutional protocol for donor hepatectomy and found fit
  • Those who consent

Exclusion criteria

  • Patients refusing to consent for inclusion in the study.
  • Left lateral hepatectomy.

Treatment and study plan

Drain Removal

Other

Abdominal drain placed during surgery removal

Primary outcomes

  1. safety of drain removal using 3x3 rule - overall complications.

    Time frame: patient will be followed upto 3 months after surgery

    Comprehensive complication index (CCI) - clavin dindo classification

Secondary outcomes

  1. Post operative pain relief

    Time frame: patient will be followed upto 3 months after surgery

    using Visual analogue score

  2. Bile leak

    Time frame: patient will be followed upto 3 months after surgery

    standard ISGLS definition - drain bilirubin measured in mg/dl.

  3. Length of hospital stay

    Time frame: patient will be followed upto 3 months after surgery

    calculated from the day of admission to day of discharge, and based on the number of nights spent in hospital

  4. Surgical Site Infection (SSI)

    Time frame: patient will be followed upto 3 months after surgery

    patient has at least one of the following:

    • purulent drainage from the superficial incision.
    • organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)).
    • superficial incision that is deliberately opened by a surgeon, physician* or physician designee and culture or non-culture based testing of the superficial incision or subcutaneous tissue is not performed AND patient has at least one of the following signs or symptoms: localized pain or tenderness; localized swelling; erythema; or heat.
    • diagnosis of a superficial incisional SSI by a physician* or physician designee.

  5. reintervention rate

    Time frame: patient will be followed upto 3 months after surgery

    defined as any additional abdominal intervention ( surgical or radiological) during the same hospital stay after the primary operation

  6. readmission rate

    Time frame: patient will be followed upto 3 months after surgery

    90 day readmission rate - any hospital admission after the index admission.

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

"Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study".

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 7, 2020
Registry last updated
May 13, 2022

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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