Superobese Patients

July 1, 2022 updated by: Fabio Medas, University of Cagliari

Predictive Factoris of Failure in Superobese Patients Undergoing Bariatric Surgery

Super obesity (SO) is defined as a Body Mass Index (BMI) > 50 kg/m2, and represents the extreme severity of the disease, resulting in an increase in morbidity, mortality, and in poorer quality of life compared with morbid obesity (BMI > 35 and <50 kg/m2).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CA
      • Cagliari, CA, Italy, 09100
        • AOU Cagliari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with BMI > 35

Description

Inclusion Criteria:

  • Morbid and superobese patients

Exclusion Criteria:

  • Follow up not completed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Superobese patients
Patients with preoperative BMI > 50
Procedure: Bariatric surgery
Sleeve gastrectomy
Morbidobese patients
Patients with preoperative BMI > 35 and <50
Procedure: Bariatric surgery
Sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical success
Time Frame: 24 months
BMI <35
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

May 30, 2021

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • SuObPat

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be made available under reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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