Quality of Life and Psychology of Donors After Hepatectomy

Prospective Comprehensive Assessment of Quality of Life and Psychology After Donor Hepatectomy

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Procedure: Donor hepatectomy

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 Type: Observational
• Enrollment (Actual): 52

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All donors undergoing donor hepatectomy

Description

Inclusion Criteriteria:

- All patients undergoing donor hepatectomy from March 2012 to August 2013

Exclusion Criteria:

- Refusal to participate in study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
live liver donors; Live liver donors undergoing donor hepatectomy	Procedure: Donor hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related quality of life: WHOQOL Bref Hindi	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.	Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cosmetic score	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)	Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
body weight	weight of donors	Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
financial status	annual income	before donation and after 2 years
donor symptoms questions	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.	Predonation and at 3 months, 1 year,2 year,3 year, 5 year

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Piyush K Sinha, MS, MCh, Assistant Professor, liver transplant surgery

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2012
• Primary Completion (Actual): August 31, 2013
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: f25/5/15/AC/ILBS/2011/213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No