Complications of Bariatric ProceduresNCT02813122
The Use of X-ray in Bariatric Surgeries
An observational study of Complications of Bariatric Procedures and X-rays; Effects, run by Assuta Medical Center at 1 site in Israel.
Trial summary
examination of the importance of the use of X-ray in bariatric surgery outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complications of Bariatric Procedures, X-rays; Effects
- What is being tested?
- x-ray
- Type of treatment
- Medical device
- How many people
- 8,000 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2016to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients underwent bariatric surgery between 2011-2015
Who may be able to join
- first bariatric surgery
Who cannot join
- recurrent bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
examination of the importance of the use of X-ray in bariatric surgery outcome.
Read the 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.
- Being tested
- x-ray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x-rayDevice
x-ray for the detection of leaks and bleeding
| Study group | Role | What they receive |
|---|---|---|
| with x-ray | patients underwent bariatric surgery and underwent x-ray Receives: Device: x-ray | |
| without x-ray | patients underwent bariatric surgery and did not underwent x-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
the outcome measure will be assessed and data will be presented in six months
Measured: retrospective- data collection and analysis will be ended in six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications of Bariatric ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
- Investigators
- Sergio G Susmallian, M.D, Principal investigator, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813122
- Sponsor's protocol ID
- 0016-16-ASMC
- Status last verified
- Feb 2017
- First submitted
- 19 Jun 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 29047049
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of X-ray in Bariatric Surgeries
- ClinicalTrials.gov ID
- NCT02813122
- Acronym / sponsor ID
- 0016-16-ASMC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with x-ray | – | Device: x-raypatients underwent bariatric surgery and underwent x-ray |
| without x-ray | – | –patients underwent bariatric surgery and did not underwent x-ray |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients underwent bariatric surgery between 2011-2015
Key inclusion criteria (1 listed)
- first bariatric surgery
Key exclusion criteria (1 listed)
- recurrent bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| x-rayx-ray for the detection of leaks and bleeding | Device | with x-ray |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Derived from this study: PubMed 29047049Susmallian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio G Susmallian, M.D principal investigator
Assuta Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications of Bariatric Procedures and X-rays; Effects, run by Assuta Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications (time frame: retrospective- data collection and analysis will be ended in six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.