NCT03938025

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

4 years

First QC Date

May 2, 2019

Last Update Submit

May 6, 2019

Conditions

Morbid Obesity

Keywords

Sleeve gastrectomyMorbid obesityResected gastric volume

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Gastric volume resected in sleeve gastrectomyPROCEDURE

Misure of resected gastric volume and outcome

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

final group from which data have been considered 92 patients (47females and 45 males)

You may qualify if:

  • 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

You may not qualify if:

  • severe and documented gastroesophageal reflux disease
  • previous gastric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • D'Ugo S, Bellato V, Bianciardi E, Gentileschi P. Impact of Resected Gastric Volume on Postoperative Weight Loss after Laparoscopic Sleeve Gastrectomy. Gastroenterol Res Pract. 2019 Dec 1;2019:3742075. doi: 10.1155/2019/3742075. eCollection 2019.

    PMID: 31871448DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bariatric Surgery Unit Chief

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 6, 2019

Study Start

January 1, 2013

Primary Completion

January 1, 2017

Study Completion

April 30, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share