Health Related Quality of Life Assessment In Egyptian Rec... | NCT01784497

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

NCT01784497

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Oct 15, 2014Estimated

Enrollment

35Actual

Phase

Not provided

Conditions

Health Related Quality of Life

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Feb 2, 2013

First Submission Date that Met QC Criteria

Feb 5, 2013

First Posted Date

Feb 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2014

Last Update Posted Date

Oct 15, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Iman Fawzy Montasser, Lecturer of tropical medicine , Ain Shams university, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Recipients of Living Donor Liver Transplantation		Patients who will undergo Living Donor Liver Transplantation (LDLT) In Ain Shams Center For Organ Transplantation (ASCOT) .

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score.		6 months

Secondary Outcomes

Measure	Description	Time Frame
Impact of post transplant medical and psychiatric complications on quality of life		6 months

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

patients who will undergo LDLT In Ain Shams Center For Organ Transplantation (ASCOT) in the next 6 months.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams Center For Organ Transplantation (ASCOT),Ain Shams university		Cairo			Egypt