Intraoperative Findings and Complications in Bariatric Surgery

Obesity, Morbid Clinical Trial

Official title:

Unexpected Intraoperative Findings and Complications in Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556306
• Other study ID #: 09-CEI-001-20160404
• Secondary ID: 212-010-22-17
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: January 1, 2017

Study information

• Verified date: June 2018
• Source: Hospital General Tlahuac
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: January 1, 2017
• Est. primary completion date: March 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with incomplete surgery data sheet and those subject to another type of bariatric surgery

Related Conditions & MeSH terms

• Bariatric Surgery
• Complication of Surgical Procedure
• Obesity, Morbid

Intervention

Procedure:
• Bariatric 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.

Locations

Country	Name	City	State
Mexico	The Obesity Clinic at Hospital General Tlahuac	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Tlahuac

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Complications	yes/no	During surgical time
Primary	Intraoperative unexpected findings, change in surgical technique, surgery interruption	yes/no	During surgical time
Secondary	Postoperative complications	(yes/no) (minor/major)	0-30 days
Secondary	Length of Hospital Stay	Days	0-30 days