Anesthesia RecoveryNCT03200964
OS Anesthesia Followup of All Bariatric Procedures at One Hospital
An observational study of Anesthesia Recovery, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Database registering demographic patient data, anesthesia and surgery information, post operative recovery and complications if any. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia Recovery
- What is being tested?
- anesthesia given as required for surgical procedure
- How many people
- 20,000 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2004to 1 Dec 2030
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing bariatric surgery
Who may be able to join
- all bariatric procedures
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bruno Dillemans, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Azsintjan
Bruges, 8000
j p mulier, MD PhD, 00 32 50 45 21 93, anesthesie@azsintjan.be
jan P mulier, PhD
About this study
Official title: Retrospective Analysis of Anesthesia Delivering for Bariatric Surgery
Database registering demographic patient data, anesthesia and surgery information, post operative recovery and complications if any.
Read the 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.
- Conditions
- Anesthesia Recovery
- Being tested
- anesthesia given as required for surgical procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia given as required for surgical procedureOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications first month after surgery.
Clavien-Dindoo classification class 2 to 5 used to describe complications
Measured: one month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startJan 2004
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia RecoveryStudies 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
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Mulier, AZ Sint-Jan AV
- Investigators
- Marco lanckneus, MD, Study chair, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200964
- Sponsor's protocol ID
- OS bariatric database
- Status last verified
- Nov 2019
- First submitted
- 26 Jun 2017
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Anesthesia Delivering for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03200964
- Acronym / sponsor ID
- OS bariatric database
- Conditions
- Anesthesia Recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Jan 2004 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 27 Jun 2017 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing bariatric surgery
Key inclusion criteria (1 listed)
- all bariatric procedures
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| anesthesia given as required for surgical procedure | Other | – |
Primary outcome
Postoperative complications first month after surgery.
Time frame: one month followup
Clavien-Dindoo classification class 2 to 5 used to describe complications
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- publication using data from ongoing registrationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anesthesia Recovery
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruiting
Effect of Opioid-free Anesthesia on Sleep Quality, Cognitive Function and Recovery Quality After General Anesthesia in Elderly Patients
Opioid-Free Anesthesia, POCD
Not yet recruitingPhase 4
Remifentanil vs Fentanyl in Children 7-12 After Urologic Surgery: Emergence Delirium and Recovery Quality
Emergence Delirium, Emergence Agitation
Not yet recruiting
Anaesthesia for Hip and Knee Arthroplasty (SPIGA)
Hip Arthroplasty, Knee Arthroplasty
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.
Bruno Dillemans, MD contact
Marco lanckneus, MD study chair
AZ Sint-Jan AV
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 Anesthesia Recovery, run by AZ Sint-Jan AV at 1 site in Belgium.
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: looking for participants now, as of the sponsor's last update on 19 Nov 2019. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan P Mulier, MD PhD (050452490, jan.mulier@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications first month after surgery. (time frame: one month followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.