Quality of Life and Psychology of Donors After Hepatectomy

NCT ID: NCT04150185

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-15
• Study Completion Date: 2018-09-01

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.

Conditions

Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

live liver donors

Live liver donors undergoing donor hepatectomy

Donor hepatectomy

Intervention Type: PROCEDURE

Interventions

Donor hepatectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Refusal to participate in study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Piyush Kumar Sinha

Assistant Professor Liver Transplant Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piyush K Sinha, MS, MCh

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, liver transplant surgery

Other Identifiers

f25/5/15/AC/ILBS/2011/213

Identifier Type: -

Identifier Source: org_study_id