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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03938025

Recruitment Status Completed

First Posted May 6, 2019

Last update posted May 7, 2019

Study Description

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:Morbid Obesity
  • Intervention/Treatment: Procedure: Gastric volume resected in sleeve gastrectomy
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 92 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title:
  • Actual Study Start Date: January 2013
  • Actual Primary Completion Date: January 2017
  • Actual Study Completion Date: April 2019
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 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.

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

University of Rome Tor Vergata

More Information
  • Responsible Party: 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Rome Tor Vergata: Sleeve gastrectomy
    Morbid obesity
    Resected gastric volume
  • Additional relevant MeSH terms: Obesity Obesity, Morbid