ClinicalTrials.gg
CompletedNCT04814290Updated Mar 24, 2021

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

An observational study in Liver Transplantation, sponsored by Mansoura University. Completed. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-03-24.

Sponsored by Mansoura University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
476
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Transplantation

Keywords

  • Living-donor liver transplantation
  • Quality of life
  • Follow up
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,115 studies on the registry; 184 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

237 living liver donors and 239 matched controls.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Older than 50 years.
  • Associated comorbidities.
  • Obesity.
  • Noncompatible ABO group.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
476 participants (actual)
Target follow-up
4 Years
Patient registry
Yes

Groups and cohorts

  • 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]).

  • 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]).

Interventions

  • Otherhealth-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 \[SF-36\]).

06

What researchers measure

Primary outcomes

  1. health-related quality of life (HRQoL)

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

    Time frame: 4 to 16 years of follow up

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Privacy for liver transplantation unit, mansoura university.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2004 to primary completion in May 2014, 120 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2021
First posted
Mar 24, 2021
StartActual
May 1, 2004
Primary completionActual
May 1, 2014
CompletionActual
Jan 1, 2021
Last update
Mar 24, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04814290
Responsible party
Ahmed Shehta (MD, PhD, Mansoura University) — Principal investigator
First posted
Mar 24, 2021
Start date
May 1, 2004
Primary completion
May 1, 2014
Completion
Jan 1, 2021
Last update
Mar 24, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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