- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02962193
Evaluation of Functional and Social Changes After Bariatric Surgery
November 10, 2016 updated by: Farraj Moaad, Western Galilee Hospital-Nahariya
After bariatric surgery there are big changes in the daily functions, activities and social participation of the patients.
This is a prospective study that examine daily performance and daily participation by questionnaires, before and after bariatric surgery.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Overweight patients who are fit for surgery .
Description
Inclusion Criteria:
- Overweight patients who are fit for surgery .
Exclusion Criteria:
- Children, Neurological patients, amputations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of participation before and after surgery
Time Frame: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
|
the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sexuality questionnaire
Time Frame: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
|
the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
|
activity daily questionnaire
Time Frame: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
|
the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
|
range of motion (flexion of knee and thigh in degrees)
Time Frame: measure will be taken before and after (3 months, 6 months) surgery.
|
measure will be taken before and after (3 months, 6 months) surgery.
|
circumferences mesurement (knee, thigh and waist) in centimeters
Time Frame: measure will be taken before and after (3 months, 6 months) surgery.
|
measure will be taken before and after (3 months, 6 months) surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
November 6, 2016
First Submitted That Met QC Criteria
November 10, 2016
First Posted (Estimate)
November 11, 2016
Study Record Updates
Last Update Posted (Estimate)
November 11, 2016
Last Update Submitted That Met QC Criteria
November 10, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0043-16-NHR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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