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NCT03938025 Clinical Trial

Impact of Resected Gastric Volume on Postoperative Weight Loss After Laparoscopic Sleeve Gastrectomy for Morbid Obesity

Morbid Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03938025
Other study ID # Gastric Volume Sleeve
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date April 30, 2019

Study information
Verified date May 2019
Source University of Rome Tor Vergata
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity. Observational study with a mathematical method to approximate the calculation of the resected gastric volume after a sleeve gastrectomy and see the outcome on weight loss.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date April 30, 2019
Est. primary completion date January 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- BMI over 60 kg/m2 in high-risk patients,

- BMI between 50 and 60 kg/m2 in nondiabetic patients,

- BMI between 40 and 50 kg/m2 in patients refusing a complex procedure like Roux-en-Y gastric bypass,

- patients with severe gastric inflammatory disease and H. pylori infection,

- patients with previous abdominal surgery involving the intestines, and young patients refusing gastric banding

Exclusion Criteria:

- severe and documented gastroesophageal reflux disease

- previous gastric surgery.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Gastric volume resected in sleeve gastrectomy
Misure of resected gastric volume and outcome

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Rome Tor Vergata

Outcome
Type Measure Description Time frame Safety issue
Primary resected gastric volume in laparoscopic sleeve gastrectomy Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity 5 years
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