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

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ClinicalTrials.gov Identifier: NCT03938025
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : May 7, 2019
Sponsor:
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



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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)
Criteria

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
ClinicalTrials.gov 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
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms