Quality of Life and Psychology of Donors After Hepatectomy

Completed

• Conditions: Quality of Life
• Interventions: Procedure: Donor hepatectomy

• Registration Number: NCT04150185
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

Liver donation by a living donor is major surgery and has a profound effect on health-related quality of life and psychology. This study aims at evaluating those aspects of a donor for a period of five years after surgery.

Detailed Description

Live donor liver transplantation (LDLT) has established itself as a treatment for end-stage liver disease but donor safety remains a major issue. It is the responsibility of the transplant team to restore donor's health, not only physical, but also mental, social and environmental. There is scarcity of long term longitudinal data on donor quality of life. Most of the studies are cross sectional which describe the quality of life at certain time point and do not take into account of changes that might occur over a period. It is more relevant in this scenario, as two persons from a family undergo surgery at the same time, which has a profound effect on family dynamics, and restoration towards normalcy goes hand in hand with adaptation to a new lifestyle. Another shortcoming of available literature is lack of uniform instruments which comprehensively measure the quality of life of live liver donors (LLDs). Standardized health related quality of life (HRQOL) instruments such as Short Form 36(SF 36) or World Health Organization quality of life Brief (WHOQOL-BREF) are not designed for LLDs. Moreover, there are several symptoms which might interfere with daily activities such as incision site problems , dyspepsia to name a few, but are not distressing enough to be reflected on quality of life scores .The aim of current study was to observe the attitude of donors pre transplant, quality of life over a period, satisfaction with the donation process, their assessment of the health care team, satisfaction with the consent process, and change in pattern of symptoms and cosmesis after surgery.

Study Timeline

• Study Start: 2012-03-15
• Primary Completion: 2013-08-31
• Study Completion: 2018-09-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-31
• Last Update Submitted: 2019-10-31
• Study First Posted: 2019-11-04
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

• Refusal to participate in study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
live liver donors	Donor hepatectomy	Live liver donors undergoing donor hepatectomy

Primary Outcome Measures

Name	Time	Method
Health Related quality of life: WHOQOL Bref Hindi	Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year	Health related quality of life measured using World Health Organization Quality of Life Brief in hindi language. There are 4 domains namely physical, psychological, social and environmental.The scores in each domain vary from 0 to 100 with higher score means better.

Secondary Outcome Measures

Name	Time	Method
cosmetic score	Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year	The body image and cosmesis questionnaire consists of eight questions combined to form two scales: a body image scale and a cosmesis scale. Five questions regarding body image assess patient's perception of their own body and their satisfaction with that perception, while also evaluating patient's attitude toward their bodily appearance. The body image scale ranges from 5 (lowest body image score) to 20 (highest body image score). Three questions regarding the cosmetic result after the operation assess the degree of satisfaction with respect to the physical appearance of the incisional scar. The combined scores of these three questions resulted in the cosmesis scale ranging from 3 (lowest satisfaction) to 24 (highest satisfaction)
financial status	before donation and after 2 years	annual income
donor symptoms questions	Predonation and at 3 months, 1 year,2 year,3 year, 5 year	These questions were based on the long term effect of cholecystectomy, incision site problems and abdominal surgery in general. The questions included gastro esophageal reflux disease (GERD)/Heartburn, nausea/vomiting, incision site discomfort and alteration in bowel habit. The number of donors reporting these symptoms were assessed to calculate the incidence at predefined time points.
body weight	Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year	weight of donors