Clinical trial NCT04150185: Quality of Life and Psychology of Donors After Hepatectomy
Official title: Prospective Comprehensive Assessment of Quality of Life and Psychology After Donor Hepatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All donors undergoing donor hepatectomy

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.

Eligibility criteria: Inclusion Criteriteria:

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

Exclusion Criteria:

- Refusal to participate in study

Primary outcomes:
measure: Health Related quality of life: WHOQOL Bref Hindi
timeFrame: Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
Secondary outcomes:
measure: cosmetic score
timeFrame: Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
measure: body weight
timeFrame: Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
measure: financial status
timeFrame: before donation and after 2 years
measure: donor symptoms questions
timeFrame: Predonation and at 3 months, 1 year,2 year,3 year, 5 year
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor, liver transplant surgery
name: Piyush K Sinha, MS, MCh
role: PRINCIPAL_INVESTIGATOR
References: