Prospective Comprehensive Assessment of Quality of Life and Psychology After Donor Hepatectomy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 52
- Primary Endpoint
- Health Related quality of life: WHOQOL Bref Hindi
Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Refusal to participate in study
Outcomes
Primary Outcomes
Health Related quality of life: WHOQOL Bref Hindi
Time Frame: 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 Outcomes
- cosmetic score(Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year)
- financial status(before donation and after 2 years)
- donor symptoms questions(Predonation and at 3 months, 1 year,2 year,3 year, 5 year)
- body weight(Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year)
Investigators
Piyush Kumar Sinha
Assistant Professor Liver Transplant Surgery
Institute of Liver and Biliary Sciences, India