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

NCT ID: NCT04814290

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 476 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-05-01
• Study Completion Date: 2021-01-01

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.

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.

Conditions

Liver Transplantation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

living liver donors

cases already underwent hepatectomy for living-donor liver transplantation.

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

Intervention Type: OTHER

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.

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

Intervention Type: OTHER

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

Interventions

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 \[SF-36\]).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Shehta

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

No. MD/15.08.50

Identifier Type: -

Identifier Source: org_study_id