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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03200964
Other study ID # OS bariatric database
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2004
Est. completion date December 1, 2030

Study information

Verified date November 2019
Source AZ Sint-Jan AV
Contact Jan P Mulier, MD PhD
Phone 050452490
Email jan.mulier@azsintjan.be
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Database registering demographic patient data, anesthesia and surgery information, post operative recovery and complications if any.


Description:

Every patient undergoing a bariatric procedure is entered in the data base after the procedure is finished, based on the information available in the medical records.

the study has no end point and keeps collecting data as long as procedures are performed.

The data is analyzed intermittent when medical questions arise on quality and outcome changes due to changes in clinical treatment taken in order to improve individual patient care.


Recruitment information / eligibility

Status Recruiting
Enrollment 20000
Est. completion date December 1, 2030
Est. primary completion date December 1, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- all bariatric procedures

Exclusion Criteria:

- none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
anesthesia given as required for surgical procedure


Locations

Country Name City State
Belgium Azsintjan Brugge

Sponsors (1)

Lead Sponsor Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications first month after surgery. Clavien-Dindoo classification class 2 to 5 used to describe complications one month followup
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