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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT04814290

Collaborator

(none)

476

Enrollment

200

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation	Other: health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).

Detailed Description

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

476 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

May 1, 2004

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	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]).

Arm

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]).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Shehta, MD, PhD, Mansoura University

ClinicalTrials.gov Identifier:

NCT04814290

Other Study ID Numbers:

No. MD/15.08.50

First Posted:

Mar 24, 2021

Last Update Posted:

Mar 24, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Shehta, MD, PhD, Mansoura University

Living-donor liver transplantation

Quality of life

Follow up

Study Results

No Results Posted as of Mar 24, 2021