NCT02813122

Brief Summary

examination of the importance of the use of X-ray in bariatric surgery outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

June 19, 2016

Last Update Submit

February 5, 2017

Conditions

Complications of Bariatric ProceduresX-rays; Effects

Outcome Measures

Primary Outcomes (1)

  • complications

    the outcome measure will be assessed and data will be presented in six months

    retrospective- data collection and analysis will be ended in six months.

Study Arms (2)

with x-ray

patients underwent bariatric surgery and underwent x-ray

Device: x-ray

without x-ray

patients underwent bariatric surgery and did not underwent x-ray

Interventions

x-rayDEVICE

x-ray for the detection of leaks and bleeding

with x-ray

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients underwent bariatric surgery between 2011-2015

You may qualify if:

  • first bariatric surgery

You may not qualify if:

  • recurrent bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta Medical Center

Tel Aviv, Israel, Israel

Location

Related Publications (1)

  • 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.

    PMID: 29047049DERIVED

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Sergio G Susmallian, M.D

    Assuta Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Surgery department

Study Record Dates

First Submitted

June 19, 2016

First Posted

June 24, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)