NCT03556306

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

3.2 years

First QC Date

May 31, 2018

Last Update Submit

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.

Also known as: Laparoscopic gastric bypass, Sleeve gastrectomy, Revisional surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

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

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • CARLOS ZERRWECK, MD

    The Obesity Clinic at Hospital General Tlahuac

    STUDY DIRECTOR
  • Paul Joo, MD

    The Obesity Cklinic at Hospital General Tlahuac

    PRINCIPAL INVESTIGATOR

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

Locations