Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy

NCT03967860 | Completed

• 1 other identifier: LSG-CT
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

CT Scan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post surgery risk

  72 hours post LSG

Interventions

CT scan DIAGNOSTIC_TEST

Post surgical standard CT Scan as predictor of complication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Francesco De Cobelli: lead

Study Sites (1)

Deaprtment of Radiology, IRCCS Ospadale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Obesity

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology, Director of Specialiaztion School in Radiology, Head of Clinical and Experimental Radiology

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: May 30, 2019
• Study Start: March 6, 2019
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)