NCT04150185

Brief Summary

Liver donation by a living donor is major surgery and has a profound effect on health-related quality of life and psychology. This study aims at evaluating those aspects of a donor for a period of five years after surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

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

Study Start

First participant enrolled

March 15, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2013

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

October 28, 2019

Last Update Submit

October 31, 2019

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Health Related quality of life: WHOQOL Bref Hindi

    Health related quality of life measured using World Health Organization Quality of Life Brief in hindi language. There are 4 domains namely physical, psychological, social and environmental.The scores in each domain vary from 0 to 100 with higher score means better.

    Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year

Secondary Outcomes (4)

  • cosmetic score

    Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year

  • body weight

    Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year

  • financial status

    before donation and after 2 years

  • donor symptoms questions

    Predonation and at 3 months, 1 year,2 year,3 year, 5 year

Study Arms (1)

live liver donors

Live liver donors undergoing donor hepatectomy

Procedure: Donor hepatectomy

Interventions

Donor hepatectomyPROCEDURE
live liver donors

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All donors undergoing donor hepatectomy

You may not qualify if:

  • \- Refusal to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Piyush K Sinha, MS, MCh

    Assistant Professor, liver transplant surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Liver Transplant Surgery

Study Record Dates

First Submitted

October 28, 2019

First Posted

November 4, 2019

Study Start

March 15, 2012

Primary Completion

August 31, 2013

Study Completion

September 1, 2018

Last Updated

November 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share