Health Related Quality of LifeNCT01784497
Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation
An observational study of Health Related Quality of Life, run by Ain Shams University at 1 site in Egypt.
Trial summary
Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Health Related Quality of Life
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to Oct 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients who will undergo LDLT In Ain Shams Center For Organ Transplantation (ASCOT) in the next 6 months.
Who may be able to join
- Adult Egyptian patients
- 18-60 years old
- Patients transplanted for HCV related disease and /or HCC
- Informed consent
Who cannot join
- Other etiologies for end stage liver disease (such as HBV and cholestatic liver disease and autoimmune hepatitis).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams Center For Organ Transplantation (ASCOT),Ain Shams university
Cairo
About this study
Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation
Read the detailed description
This Study Aims to Evaluate:-
- Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score.
- Impact of post transplant medical and psychiatric complications on quality of life
- Conditions
- Health Related Quality of Life
- Keywords
- Health Related Quality of Life (HRQL), Living Donor Liver Transplantation(LDLT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recipients of Living Donor Liver Transplantation | Patients who will undergo Living Donor Liver Transplantation (LDLT) In Ain Shams Center For Organ Transplantation (ASCOT) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score.
Measured: 6 months
Secondary outcomes (1)
Impact of post transplant medical and psychiatric complications on quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Related Quality of LifeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784497
- Sponsor's protocol ID
- PostTransplant Quality of life
- Status last verified
- Oct 2014
- First submitted
- 2 Feb 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT01784497
- Acronym / sponsor ID
- PostTransplant Quality of life
- Conditions
- Health Related Quality of Life
- Keywords
- Health Related Quality of Life (HRQL), Living Donor Liver Transplantation(LDLT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Feb 2013 (estimated)
- 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.
Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation
Detailed description
This Study Aims to Evaluate:-
- Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score.
- Impact of post transplant medical and psychiatric complications on quality of life
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recipients of Living Donor Liver Transplantation | – | –Patients who will undergo Living Donor Liver Transplantation (LDLT) In Ain Shams Center For Organ Transplantation (ASCOT) . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients who will undergo LDLT In Ain Shams Center For Organ Transplantation (ASCOT) in the next 6 months.
Key inclusion criteria (4 listed)
- Adult Egyptian patients
- 18-60 years old
- Patients transplanted for HCV related disease and /or HCC
- Informed consent
Key exclusion criteria (1 listed)
- Other etiologies for end stage liver disease (such as HBV and cholestatic liver disease and autoimmune hepatitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score.
Time frame: 6 months
1 secondary outcome
Impact of post transplant medical and psychiatric complications on quality of life
Time frame: 6 months
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 15 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Related Quality of Life, run by Ain Shams University at 1 site in Egypt.
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 4 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score. (time frame: 6 months). 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 15 Oct 2014.