Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy (LSG-CT)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Diagnostic test: CT scan

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20132
    • Deaprtment of Radiology, IRCCS Ospadale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Obese patients with BMI ≥ 40 kg/m2 or between 35 e 40 kg/m2 with evidence of obesity related comorbidity

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of Post surgery CT in identifying risks for subsequent development of gastric fistula	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	72 hours post LSG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post surgery risk	Risk stratification based on the correlation of the measurements obtained from the primary objective on outcome (complication vs non complication).	72 hours post LSG

Collaborators and Investigators

• Sponsor: Francesco De Cobelli

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2019
• Primary Completion (ACTUAL): May 6, 2019
• Study Completion (ACTUAL): May 6, 2019

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (ACTUAL): May 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: CT Scan
• Other Study ID Numbers: LSG-CT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No