Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy

Completed

• Conditions: Obesity

• Registration Number: NCT03967860
• Lead Sponsor: Francesco De Cobelli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-06
• Study First Submitted: 2019-04-02
• Primary Completion: 2019-05-06
• Study Completion: 2019-05-06
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-24
• Last Update Posted: 2019-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Value of Post surgery CT in identifying risks for subsequent development of gastric fistula	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 Outcome Measures

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

Trial Locations

Locations (1)

Deaprtment of Radiology, IRCCS Ospadale San Raffaele; 🇮🇹 Milano, Italy