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OpenTrials
Completed

NCT Number: NCT03967860

Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy

Obesity is a extremely widespread condition in Europe and North America, burdened by a series of complications characterized by major morbidity and morbility. In recent years, bariatric surgery has progressively assumed a leading role in the treatment of morbid obesity and restrictive bariatric surgery procedures, such as laparoscopic vertical sleeve gastrectomy are common.

The aim of the study is to retrospectively determine the value of postoperative CT after LSG as an early tool to identify risk factors for the subsequent development of gastric fistula and enable to stratify postoperative risk in asymptomatic patients and ensure effective management of these risk factors.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Deaprtment of Radiology, IRCCS Ospadale San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult obese patients with LSG
  • BMI ≥ 40 kg/m2 or BMI between 35 and 40 kg/m2
  • evidence of obesity related comorbidity
  • availability of upper abdomen CT scan with IV and oral contrast medium within 72 hours of surgery

Exclusion criteria

  • Pregnant women
  • allergy to contract medium
  • lack of venous access
  • patients who did not have a post-surgical upper abdomen CT

Treatment and study plan

CT Scan

Diagnostic Test

Post surgical standard CT Scan as predictor of complication

Primary outcomes

  1. Value of Post surgery CT in identifying risks for subsequent development of gastric fistula

    Time frame: 72 hours post LSG

    Measurements of: presence or abscence of fistula and site; presence/abscence of hematoma and site; presence/abscence of gastric torsion; Stapler to pylorus distance and stapler length

Secondary outcomes

  1. Post surgery risk

    Time frame: 72 hours post LSG

    Risk stratification based on the correlation of the measurements obtained from the primary objective on outcome (complication vs non complication).

Sponsors and collaborators

Lead sponsor

Francesco De Cobelli

Other

Registry information

Acronym: LSG-CT

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 30, 2019
Registry last updated
Dec 26, 2019

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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