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OpenTrials
Completed

NCT Number: NCT03556306

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Obesity Clinic at Hospital General Tlahuac

Mexico City, 13250, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

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.

Other names: Laparoscopic gastric bypass, Sleeve gastrectomy, Revisional surgery

Primary outcomes

  1. Intraoperative Complications

    Time frame: During surgical time

    yes/no

  2. Intraoperative unexpected findings, change in surgical technique, surgery interruption

    Time frame: During surgical time

    yes/no

Secondary outcomes

  1. Postoperative complications

    Time frame: 0-30 days

    (yes/no) (minor/major)

  2. Length of Hospital Stay

    Time frame: 0-30 days

    Days

Sponsors and collaborators

Lead sponsor

Hospital General Tlahuac

Other Gov

Registry information

Official study title

Unexpected Intraoperative Findings and Complications in Bariatric Surgery

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 14, 2018
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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