Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

OS Anesthesia Followup of All Bariatric Procedures at One Hospital

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200964
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jan Mulier, AZ Sint-Jan AV

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

Condition or disease Intervention/treatment
Anesthesia Recovery Other: anesthesia given as required for surgical procedure

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Retrospective Analysis of Anesthesia Delivering for Bariatric Surgery
Actual Study Start Date : January 2004
Estimated Primary Completion Date : December 1, 2030
Estimated Study Completion Date : December 1, 2030



Primary Outcome Measures :
  1. Postoperative complications first month after surgery. [ Time Frame: one month followup ]
    Clavien-Dindoo classification class 2 to 5 used to describe complications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing bariatric surgery
Criteria

Inclusion Criteria:

  • all bariatric procedures

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200964


Contacts
Layout table for location contacts
Contact: Jan P Mulier, MD PhD 050452490 jan.mulier@azsintjan.be
Contact: Bruno Dillemans, MD

Locations
Layout table for location information
Belgium
Azsintjan Recruiting
Brugge, Belgium, 8000
Contact: j p mulier, MD PhD    00 32 50 45 21 93    anesthesie@azsintjan.be   
Principal Investigator: jan P mulier, PhD         
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
Layout table for investigator information
Study Chair: Marco lanckneus, MD AZ Sint-Jan AV
Additional Information:
Layout table for additonal information
Responsible Party: Jan Mulier, chairman dep anesthesiology, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT03200964    
Other Study ID Numbers: OS bariatric database
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs