Intraoperative Findings and Complications in Bariatric Surgery

June 12, 2018 updated by: CARLOS ZERRWECK LOPEZ, Hospital General Tlahuac

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

405

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 13250
        • The Obesity Clinic at Hospital General Tlahuac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with obesity submitted to bariatric surgery (LGBP, LSG, and revisional surgery) in a single institution between January 2013 and March 2016.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Complications
Time Frame: During surgical time
yes/no
During surgical time
Intraoperative unexpected findings, change in surgical technique, surgery interruption
Time Frame: During surgical time
yes/no
During surgical time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 0-30 days
(yes/no) (minor/major)
0-30 days
Length of Hospital Stay
Time Frame: 0-30 days
Days
0-30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Tlahuac

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

March 30, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-CEI-001-20160404
  • 212-010-22-17 (Registry Identifier: Institutional Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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