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Clinical Trials/NCT04504487
NCT04504487CompletedNot Applicable

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

Institute of Liver and Biliary Sciences, India2 sites in 1 country108 target enrollmentStarted: January 28, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
108
Locations
2
Primary Endpoint
safety of drain removal using 3x3 rule - overall complications.

Study Overview

Brief Summary

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.

Detailed Description

  • 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

  1. Early detection of haemorrhage

  2. Early detection of bile leak

  3. Early reintervention Disadvantages

  4. 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

  • Length of hospital stay(patient will be followed upto 3 months after surgery)
  • Post operative pain relief(patient will be followed upto 3 months after surgery)
  • Surgical Site Infection (SSI)(patient will be followed upto 3 months after surgery)
  • Bile leak(patient will be followed upto 3 months after surgery)
  • reintervention rate(patient will be followed upto 3 months after surgery)
  • readmission rate(patient will be followed upto 3 months after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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