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The Use of X-ray in Bariatric Surgeries

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: NCT02813122
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Sergio Gabriel Susmallian, Assuta Medical Center

Tracking Information
First Submitted Date June 19, 2016
First Posted Date June 24, 2016
Last Update Posted Date February 7, 2017
Study Start Date June 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2016)
complications [ Time Frame: retrospective- data collection and analysis will be ended in six months. ]
the outcome measure will be assessed and data will be presented in six months
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Use of X-ray in Bariatric Surgeries
Official Title The Use of X-ray in Bariatric Surgeries
Brief Summary examination of the importance of the use of X-ray in bariatric surgery outcome.
Detailed Description the x-ray will be used in order to evaluate the number of complications occured during bariatric surgeries such as bleeding, leak, etc. a retrospective analysis of patients with those complications will be performed and the presence of the x-ray and its findings will also be documented.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients underwent bariatric surgery between 2011-2015
Condition
  • Complications of Bariatric Procedures
  • X-rays; Effects
Intervention Device: x-ray
x-ray for the detection of leaks and bleeding
Study Groups/Cohorts
  • with x-ray
    patients underwent bariatric surgery and underwent x-ray
    Intervention: Device: x-ray
  • without x-ray
    patients underwent bariatric surgery and did not underwent x-ray
Publications * Susmallian S, Folb E, Barnea R, Raziel A. Comparison of Imaging Modalities for Detecting Complications in Bariatric Surgery. Obes Surg. 2018 Apr;28(4):1063-1069. doi: 10.1007/s11695-017-2970-5.

*   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: June 22, 2016)
8000
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

first bariatric surgery

Exclusion Criteria:

recurrent bariatric surgery

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT02813122
Other Study ID Numbers 0016-16-ASMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sergio Gabriel Susmallian, Assuta Medical Center
Study Sponsor Assuta Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Sergio G Susmallian, M.D Assuta Medical Center
PRS Account Assuta Medical Center
Verification Date February 2017