OS Anesthesia Followup of All Bariatric Procedures at One... | NCT03200964

Studies
OS Anesthesia Followup of All Bariatric Procedures at One Hospital

NCT03200964

Sponsor

AZ Sint-Jan AV

Status

Recruiting

Last Update Posted

Nov 19, 2019Actual

Enrollment

20,000Estimated

Phase

Not provided

Conditions

Anesthesia Recovery

Interventions

anesthesia given as required for surgical procedure

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004Actual

Primary Completion Date

Dec 1, 2030Estimated

Completion Date

Dec 1, 2030Estimated

First Submitted Date

Jun 26, 2017

First Submission Date that Met QC Criteria

Jun 26, 2017

First Posted Date

Jun 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2019

Last Update Posted Date

Nov 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
anesthesia given as required for surgical procedure	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative complications first month after surgery.	Clavien-Dindoo classification class 2 to 5 used to describe complications	one month followup

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all bariatric procedures

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients undergoing bariatric surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jan P Mulier, MD PhD	Contact	050452490		jan.mulier@azsintjan.be
Bruno Dillemans, MD	Contact

Overall Officials

Name	Affiliation	Role
Marco lanckneus, MD	AZ Sint-Jan AV	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azsintjan	Recruiting	Bruges		8000	Belgium

Label	URL
publication using data from ongoing registration	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided