Quality of Life and Psychology of Donors After Hepatectomy

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150185
• Other study ID #: f25/5/15/AC/ILBS/2011/213
• Status: Completed
• Start date: March 15, 2012
• Est. completion date: September 1, 2018

Study information

• Verified date: October 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 1, 2018
• Est. primary completion date: August 31, 2013
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteriteria:

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

Exclusion Criteria:

• Refusal to participate in study

Related Conditions & MeSH terms

• Quality of Life

Intervention

Procedure:
• Donor hepatectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	body weight	weight of donors	Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
Secondary	financial status	annual income	before donation and after 2 years
Secondary	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