NCT05446246

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

3.4 years

First QC Date

July 1, 2022

Last Update Submit

July 1, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Surgical success

    BMI \<35

    24 months

Study Arms (2)

Superobese patients

Patients with preoperative BMI \> 50

Procedure: Bariatric surgery

Morbidobese patients

Patients with preoperative BMI \> 35 and \<50

Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

Sleeve gastrectomy

Morbidobese patientsSuperobese patients

Eligibility Criteria

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

Patients with BMI \> 35

You may qualify if:

  • Morbid and superobese patients

You may not qualify if:

  • Follow up not completed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Cagliari

Cagliari, CA, 09100, Italy

Location

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 6, 2022

Study Start

January 1, 2018

Primary Completion

May 30, 2021

Study Completion

September 30, 2022

Last Updated

July 6, 2022

Record last verified: 2022-07

Locations

IT(1)