Morbid ObesityNCT03419104
Preoperative Exercise Test and Postoperative Intensive Care Unit Need in Bariatric Surgery
A study testing preoperative walk test in people with Morbid Obesity and Weaning Failure, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to evaluate the efficacy of "60 meters 60 seconds exercise test" (a test designed by the study group) done preoperatively as a predictor test for postoperative intensive care unit need and extubation success in patients undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity, Weaning Failure
- What is being tested?
- preoperative walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Aug 2018
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients between 18-60 years old patients with BMI > 40 patients undergoing Laparoscopic Sleeve Gastrectomy
Who cannot join
- patients with Chronic obstructive pulmonary disease (COPD) or Asthma, patients with uncompensated heart failure Patients Who have orthopedic problems that effects the exercise test (such as gonarthrosis)
Trial locations and contacts
1 site in 1 country.
cigdem akyol, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34500
emre erbabacan, asc prof, 5322067777, emreerbabacan@gmail.com
About this study
Official title: Use of Preoperative Exercise Test as Predictor for Postoperative Intensive Care Unit Need in Patients Undergoing Bariatric Surgery
The aim of our study is to evaluate the efficacy of "60 meters 60 seconds exercise test" (a test designed by the study group) done preoperatively as a predictor test for postoperative intensive care unit need and extubation success in patients undergoing bariatric surgery.
- Conditions
- Morbid Obesity, Weaning Failure
- Being tested
- preoperative walk test
- Keywords
- bariatric surgery, extubation
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative walk testDiagnostic test
Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative walk test | Experimental | Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test. Receives: Diagnostic Test: preoperative walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
extubation
Number of participants with successful extubation and patients who does not need mechanical ventilation support
Measured: one hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Mar 2018
- Primary completion30 Jun 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
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 Morbid ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419104
- Sponsor's protocol ID
- IstanbulU ctf
- Status last verified
- Mar 2018
- First submitted
- 26 Jan 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gupta PK, Gupta H, Kaushik M, Fang X, Miller WJ, Morrow LE, Armour-Forse R. Predictors of pulmonary complications after bariatric surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):574-81. doi: 10.1016/j.soard.2011.04.227. Epub 2011 May 13.
PubMed 21719358
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Preoperative Exercise Test as Predictor for Postoperative Intensive Care Unit Need in Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03419104
- Acronym / sponsor ID
- IstanbulU ctf
- Conditions
- Morbid Obesity, Weaning Failure
- Keywords
- bariatric surgery, extubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 1 Feb 2018 (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.
The aim of our study is to evaluate the efficacy of "60 meters 60 seconds exercise test" (a test designed by the study group) done preoperatively as a predictor test for postoperative intensive care unit need and extubation success in patients undergoing bariatric surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative walk test | Experimental | Diagnostic Test: preoperative walk testPatients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients between 18-60 years old patients with BMI > 40 patients undergoing Laparoscopic Sleeve Gastrectomy
Key exclusion criteria (1 listed)
- patients with Chronic obstructive pulmonary disease (COPD) or Asthma, patients with uncompensated heart failure Patients Who have orthopedic problems that effects the exercise test (such as gonarthrosis)
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 |
|---|---|---|
| preoperative walk testPatients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test. | Diagnostic test | Preoperative walk test |
Primary outcome
extubation
Time frame: one hour postoperative
Number of participants with successful extubation and patients who does not need mechanical ventilation support
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Results publication: PubMed 21719358Gupta PK, Gupta H, Kaushik M, Fang X, Miller WJ, Morrow LE, Armour-Forse R. Predictors of pulmonary complications after bariatric surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):574-81. doi: 10.1016/j.soard.2011.04.227. Epub 2011 May 13.
- Individual participant dataSharing planned: Undecided
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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.
cigdem akyol, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative walk test in people with Morbid Obesity and Weaning Failure, run by Istanbul University at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 13 Mar 2018. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact emre erbabacan, asc prof (5322067777, emreerbabacan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extubation (time frame: one hour postoperative). 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 NCT03419104, 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 13 Mar 2018.