NCT04504487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 28, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
Last Updated

May 13, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

July 30, 2020

Last Update Submit

May 9, 2022

Conditions

Liver Transplant

Outcome Measures

Primary Outcomes (1)

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

    Comprehensive complication index (CCI) - clavin dindo classification

    patient will be followed upto 3 months after surgery

Secondary Outcomes (6)

  • Post operative pain relief

    patient will be followed upto 3 months after surgery

  • Bile leak

    patient will be followed upto 3 months after surgery

  • Length of hospital stay

    patient will be followed upto 3 months after surgery

  • Surgical Site Infection (SSI)

    patient will be followed upto 3 months after surgery

  • reintervention rate

    patient will be followed upto 3 months after surgery

  • +1 more secondary outcomes

Study Arms (2)

Early drain removal - POD3

EXPERIMENTAL

Drain removal on POD3 if drain bilirubin is less than 3mg/dl and serous in nature.

Other: Drain Removal

Routine Drain Removal

PLACEBO COMPARATOR

Drain removed routinely when the output is less than 100ml and serous in nature

Other: Drain Removal

Interventions

Drain RemovalOTHER

Abdominal drain placed during surgery removal

Early drain removal - POD3Routine Drain Removal

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Left lateral hepatectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ILBS - Parthiban

Delhi, 110070, India

Location

Related Publications (1)

  • Durairaj P, Pamecha V, Mohapatra N, Patil NS, Sindwani G. Early drain removal after live liver donor hepatectomy is safe - a randomized controlled pilot study. Langenbecks Arch Surg. 2023 Sep 5;408(1):350. doi: 10.1007/s00423-023-03088-9.

    PMID: 37670194DERIVED

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 7, 2020

Study Start

January 28, 2021

Primary Completion

February 25, 2022

Study Completion

February 25, 2022

Last Updated

May 13, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)