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NCT04814290 Clinical Trial

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

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04814290
Other study ID # No. MD/15.08.50
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2004
Est. completion date January 1, 2021

Study information
Verified date March 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 476
Est. completion date January 1, 2021
Est. primary completion date May 1, 2014
Accepts healthy volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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]).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

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