Long-term Follow-up of Living Liver Donors: A Single-center Experience

March 22, 2021 updated by: Ahmed Shehta, Mansoura University
Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.

We used the 36-item short-form health survey (short form-36 health survey, version 1 [SF-36]). The scores for the 4 following subscales were higher in nondonors than in donors: physical functioning (P = 0.009), role limitations due to physical health (P = 0.002), energy/fatigue (P < 0.001), and bodily pain (P < 0.001). The scores on the 8 subscales of the SF-36 were higher in donors with living recipients than in donors whose recipients died (P < 0.001). Our results suggest that living donor right hepatectomy is safe and results in a postdonation HRQoL similar to that of nondonors in those donors whose recipients are healthy, while donors whose recipients die have a lower HRQoL that is significantly negatively correlated with the time since recipient death and improves over time.

Study Type

Observational

Enrollment (Actual)

476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

237 living liver donors and 239 matched controls.

Description

Inclusion Criteria:

  • age 18-50 years
  • no comorbidities.
  • BMI less than 30 kg/m2.
  • compatible ABO group.

Exclusion Criteria:

  • Older than 50 years.
  • Associated comorbidities.
  • Obesity.
  • Noncompatible ABO group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
living liver donors
cases already underwent hepatectomy for living-donor liver transplantation.
Other: health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).
health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).
matched controls
healthy persons who attended the preoperative clinic while preparing for donation but were rejected because of an ABO blood group mismatch.
Other: health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).
health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health-related quality of life (HRQoL)
Time Frame: 4 to 16 years of follow up
health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).
4 to 16 years of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2004

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • No. MD/15.08.50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Privacy for liver transplantation unit, mansoura university.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Transplantation

Clinical Trials on health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).

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