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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03938025
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : May 7, 2019
Information provided by (Responsible Party):
Paolo Gentileschi, University of Rome Tor Vergata

Brief 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.

Condition or disease Intervention/treatment
Morbid Obesity Procedure: Gastric volume resected in sleeve gastrectomy

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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

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

Primary Outcome Measures :
  1. resected gastric volume in laparoscopic sleeve gastrectomy [ Time Frame: 5 years ]
    Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
final group from which data have been considered 92 patients (47females and 45 males)

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.

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Responsible Party: Paolo Gentileschi, Bariatric Surgery Unit Chief, University of Rome Tor Vergata Identifier: NCT03938025     History of Changes
Other Study ID Numbers: Gastric Volume Sleeve
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paolo Gentileschi, University of Rome Tor Vergata:
Sleeve gastrectomy
Morbid obesity
Resected gastric volume
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms