Bariatric SurgeryNCT03556306
Intraoperative Findings and Complications in Bariatric Surgery
An observational study of Bariatric Surgery and Complication of Surgical Procedure, run by Hospital General Tlahuac at 1 site in Mexico.
Trial summary
Retrospective study with patients submitted to bariatric surgery between 2013 and 2016 at a single Institution. The objective was to analyze the incidence and causes of unexpected intraoperative findings and complications, change in surgical plan, extra surgeries and procedure interruption. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery, Complication of Surgical Procedure, Obesity, Morbid
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 405 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2013to 1 Jan 2017
- Phase
- Observational
- 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
Study population: Patients with obesity submitted to bariatric surgery (LGBP, LSG, and revisional surgery) in a single institution between January 2013 and March 2016.
Who may be able to join
- Patient submitted to bariatric surgery
- All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity
Who cannot join
- Patients with incomplete surgery data sheet and those subject to another type of bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unexpected Intraoperative Findings and Complications in Bariatric Surgery
Retrospective study with patients submitted to bariatric surgery between 2013 and 2016 at a single Institution. The objective was to analyze the incidence and causes of unexpected intraoperative findings and complications, change in surgical plan, extra surgeries and procedure interruption. All operative information was collected prospectively and aimed to describe any of the previous situations. Secondarily, a morbidity analysis was performed, correlating intraoperative complications with postoperative complications and length of stay.
- Being tested
- Bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Also called Laparoscopic gastric bypass, Sleeve gastrectomy, Revisional surgery
The gastric bypass ("simplified technique") was performed in an antecolic fashion, with a calibrated 2 cm gastro-jejunal anastomosis (linear stapler); biliary and alimentary limbs measured 70 and 150 cm respectively [17] . Mesenteric defects were closed and the omentum divided. The sleeve gastrectomy was performed at 5-6 cm from the pylorus over a 36 Fr. bougie, with oversuture of the staple line (2-0 polypropylene). Methylene blue test and the use of drains were done routinely.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Complications
yes/no
Measured: During surgical time
Intraoperative unexpected findings, change in surgical technique, surgery interruption
yes/no
Measured: During surgical time
Secondary outcomes (2)
Postoperative complications
(yes/no) (minor/major)
Measured: 0-30 days
Length of Hospital Stay
Days
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Jan 2013
- Primary completion30 Mar 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- Retrospective
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Tlahuac
- Sponsor type
- Other government
- Responsible party
- Principal investigator, CARLOS ZERRWECK LOPEZ, Hospital General Tlahuac
- Investigators
- CARLOS ZERRWECK, MD, Study director, The Obesity Clinic at Hospital General TlahuacPaul Joo, MD, Principal investigator, The Obesity Cklinic at Hospital General Tlahuac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556306
- Sponsor's protocol ID
- 09-CEI-001-20160404
- Other IDs
- 212-010-22-17
- Status last verified
- Jun 2018
- First submitted
- 31 May 2018
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unexpected Intraoperative Findings and Complications in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03556306
- Acronym / sponsor ID
- 09-CEI-001-20160404
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Hospital General TlahuacOther government
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 14 Jun 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.
Retrospective study with patients submitted to bariatric surgery between 2013 and 2016 at a single Institution. The objective was to analyze the incidence and causes of unexpected intraoperative findings and complications, change in surgical plan, extra surgeries and procedure interruption. All operative information was collected prospectively and aimed to describe any of the previous situations. Secondarily, a morbidity analysis was performed, correlating intraoperative complications with postoperative complications and length of stay.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with obesity submitted to bariatric surgery (LGBP, LSG, and revisional surgery) in a single institution between January 2013 and March 2016.
Key inclusion criteria (2 listed)
- Patient submitted to bariatric surgery
- All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity
Key exclusion criteria (1 listed)
- Patients with incomplete surgery data sheet and those subject to another type of bariatric surgery
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 |
|---|---|---|
| Bariatric surgeryAlso: Laparoscopic gastric bypass, Sleeve gastrectomy, Revisional surgeryThe gastric bypass ("simplified technique") was performed in an antecolic fashion, with a calibrated 2 cm gastro-jejunal anastomosis (linear stapler); biliary and alimentary limbs measured 70 and 150 cm respectively [17] . Mesenteric defects were closed and the omentum divided. The sleeve gastrectomy was performed at 5-6 cm from the pylorus over a 36 Fr. bougie, with oversuture of the staple line (2-0 polypropylene). Methylene blue test and the use of drains were done routinely. | Procedure or surgery | – |
Primary outcome
Intraoperative Complications
Time frame: During surgical time
yes/no
Intraoperative unexpected findings, change in surgical technique, surgery interruption
Time frame: During surgical time
yes/no
2 secondary outcomes
Postoperative complications
Time frame: 0-30 days
Length of Hospital Stay
Time frame: 0-30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- 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.
CARLOS ZERRWECK, MD study director
The Obesity Clinic at Hospital General Tlahuac
Paul Joo, MD principal investigator
The Obesity Cklinic at Hospital General Tlahuac
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 Bariatric Surgery and Complication of Surgical Procedure, run by Hospital General Tlahuac at 1 site in Mexico.
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 2 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: finished, as of the sponsor's last update on 14 Jun 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Complications (time frame: During surgical time). The study lists 2 primary outcomes in all. 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 14 Jun 2018.