Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy

Obesity Clinical Trial

— LSG-CT  

Official title:

Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967860
• Other study ID #: LSG-CT
• Status: Completed
• Start date: March 6, 2019
• Est. completion date: May 6, 2019

Study information

• Verified date: December 2019
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 6, 2019
• Est. primary completion date: May 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Diagnostic Test:
• CT scan
Post surgical standard CT Scan as predictor of complication

Locations

Country	Name	City	State
Italy	Deaprtment of Radiology, IRCCS Ospadale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Francesco De Cobelli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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