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临床试验/NCT04150185
NCT04150185已完成不适用

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

Institute of Liver and Biliary Sciences, India0 个研究点目标入组 52 人开始时间: 2012年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
主要终点
Health Related quality of life: WHOQOL Bref Hindi

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Refusal to participate in study

结局指标

主要结局

Health Related quality of life: WHOQOL Bref Hindi

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Piyush Kumar Sinha

Assistant Professor Liver Transplant Surgery

Institute of Liver and Biliary Sciences, India

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