Intraoperative Findings and Complications in Bariatric Surgery

NCT ID: NCT03556306

Last Updated: 2018-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

405 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2017-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Bariatric Surgery Complication of Surgical Procedure Obesity, Morbid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic gastric bypass Sleeve gastrectomy Revisional surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Tlahuac

OTHER_GOV

Sponsor Role lead

Responsible Party

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CARLOS ZERRWECK LOPEZ

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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CARLOS ZERRWECK, MD

Role: STUDY_DIRECTOR

The Obesity Clinic at Hospital General Tlahuac

Paul Joo, MD

Role: PRINCIPAL_INVESTIGATOR

The Obesity Cklinic at Hospital General Tlahuac

Locations

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The Obesity Clinic at Hospital General Tlahuac

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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212-010-22-17

Identifier Type: REGISTRY

Identifier Source: secondary_id

09-CEI-001-20160404

Identifier Type: -

Identifier Source: org_study_id

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