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Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01784497
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University

Tracking Information
First Submitted Date February 2, 2013
First Posted Date February 6, 2013
Last Update Posted Date October 15, 2014
Study Start Date January 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 5, 2013)
Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score. [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01784497 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 5, 2013)
Impact of post transplant medical and psychiatric complications on quality of life [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation
Official Title Not Provided
Brief Summary Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation
Detailed Description

This Study Aims to Evaluate:-

  1. Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score.
  2. Impact of post transplant medical and psychiatric complications on quality of life
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients who will undergo LDLT In Ain Shams Center For Organ Transplantation (ASCOT) in the next 6 months.
Condition Health Related Quality of Life
Intervention Not Provided
Study Groups/Cohorts Recipients of Living Donor Liver Transplantation
Patients who will undergo Living Donor Liver Transplantation (LDLT) In Ain Shams Center For Organ Transplantation (ASCOT) .
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 12, 2014)
35
Original Estimated Enrollment
 (submitted: February 5, 2013)
30
Actual Study Completion Date October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult Egyptian patients
  • 18-60 years old
  • Patients transplanted for HCV related disease and /or HCC
  • Informed consent

Exclusion Criteria:

  • Other etiologies for end stage liver disease (such as HBV and cholestatic liver disease and autoimmune hepatitis).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT01784497
Other Study ID Numbers PostTransplant Quality of life
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Iman Fawzy Montasser, Ain Shams University
Study Sponsor Ain Shams University
Collaborators Not Provided
Investigators Not Provided
PRS Account Ain Shams University
Verification Date October 2014