Quality of LifeNCT04150185
Quality of Life and Psychology of Donors After Hepatectomy
An observational study of Quality of Life, run by Institute of Liver and Biliary Sciences, India.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Life
- What is being tested?
- Donor hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2012to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All donors undergoing donor hepatectomy
Who may be able to join
- All patients undergoing donor hepatectomy from March 2012 to August 2013
Who cannot join
- Refusal to participate in study
About this study
Official title: Prospective Comprehensive Assessment of Quality of Life and Psychology After Donor Hepatectomy
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.
Read the 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
- Being tested
- Donor hepatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor hepatectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| live liver donors | Live liver donors undergoing donor hepatectomy Receives: Procedure: Donor hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
Secondary outcomes (4)
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)
Measured: Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
body weight
weight of donors
Measured: Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
financial status
annual income
Measured: before donation and after 2 years
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.
Measured: Predonation and at 3 months, 1 year,2 year,3 year, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start15 Mar 2012
- Primary completion31 Aug 2013
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piyush Kumar Sinha, Institute of Liver and Biliary Sciences, India
- Investigators
- Piyush K Sinha, MS, MCh, Principal investigator, Assistant Professor, liver transplant surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150185
- Sponsor's protocol ID
- f25/5/15/AC/ILBS/2011/213
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comprehensive Assessment of Quality of Life and Psychology After Donor Hepatectomy
- ClinicalTrials.gov ID
- NCT04150185
- Acronym / sponsor ID
- f25/5/15/AC/ILBS/2011/213
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Mar 2012 (actual)
- Primary completion
- 31 Aug 2013 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| live liver donors | – | Procedure: Donor hepatectomyLive liver donors undergoing donor hepatectomy |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All donors undergoing donor hepatectomy
Key inclusion criteria (1 listed)
- All patients undergoing donor hepatectomy from March 2012 to August 2013
Key exclusion criteria (1 listed)
- Refusal to participate in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donor hepatectomy | Procedure or surgery | live liver donors |
Primary outcome
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.
4 secondary outcomes
cosmetic score
Time frame: Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
body weight
Time frame: Predonation and at 1week,1 month, 3 months, 1 year,2 year,3 year, 5 year
financial status
Time frame: before donation and after 2 years
donor symptoms questions
Time frame: Predonation and at 3 months, 1 year,2 year,3 year, 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piyush K Sinha, MS, MCh principal investigator
Assistant Professor, liver transplant surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Institute of Liver and Biliary Sciences, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.