Intraoperative Findings and Complications in Bariatric Surgery
Unexpected Intraoperative Findings and Complications in Bariatric Surgery
2 other identifiers
observational
405
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 31, 2018
CompletedFirst Posted
Study publicly available on registry
June 14, 2018
CompletedJune 14, 2018
June 1, 2018
3.2 years
May 31, 2018
June 12, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Intraoperative Complications
yes/no
During surgical time
Intraoperative unexpected findings, change in surgical technique, surgery interruption
yes/no
During surgical time
Secondary Outcomes (2)
Postoperative complications
0-30 days
Length of Hospital Stay
0-30 days
Interventions
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.
Eligibility Criteria
Patients with obesity submitted to bariatric surgery (LGBP, LSG, and revisional surgery) in a single institution between January 2013 and March 2016.
You may qualify if:
- 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
You may not qualify if:
- Patients with incomplete surgery data sheet and those subject to another type of bariatric surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Obesity Clinic at Hospital General Tlahuac
Mexico City, 13250, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
CARLOS ZERRWECK, MD
The Obesity Clinic at Hospital General Tlahuac
- PRINCIPAL INVESTIGATOR
Paul Joo, MD
The Obesity Cklinic at Hospital General Tlahuac
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 31, 2018
First Posted
June 14, 2018
Study Start
January 1, 2013
Primary Completion
March 30, 2016
Study Completion
January 1, 2017
Last Updated
June 14, 2018
Record last verified: 2018-06