NCT05529199

Brief Summary

Obesity is one of the greatest pandemics of the 21st century with 30 million new cases each year. In France each year, 60,000 bariatric surgery procedures are performed. Many preoperative diets have been proposed in the literature with some studies giving positive results. But these diets are often strict and can have adverse effects on metabolism. Very few studies have described the PSMF diet. The hypothesis would be that this diet is associated with a reduction in liver volume with a reduction in steatosis.

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
776

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

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

First Submitted

Initial submission to the registry

August 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

August 31, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

August 30, 2022

Last Update Submit

December 12, 2023

Conditions

Obesity, Abdominal

Keywords

Obesity, AbdominalPreoperative dietsPSMF diet

Outcome Measures

Primary Outcomes (1)

  • liver volume measurement in cm

    Files analysed retrospectively from Ocober 01, 2010 to December 31, 2021 will be examined

Eligibility Criteria

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

Adult patients (≥18 years old) operated on at the HUS between 2010 and 2021 for bariatric surgery

You may qualify if:

  • Adult patient (≥18 years old)
  • Man and woman
  • Patient operated on at the HUS between 2010 and 2021 for bariatric surgery
  • Patient not objecting to the reuse of their data for scientific research purposes.

You may not qualify if:

  • \- Patient who has expressed his opposition to the reuse of his data for scientific research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de chirurgie générale et digestive - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

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

Study Officials

  • Benoit ROMAIN, MD, PhD

    Service de chirurgie générale et digestive - CHU de Strasbourg - France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benoit ROMAIN, MD, PhD

CONTACT

33 3 88 12 72 37benoit.romain@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 6, 2022

Study Start

August 31, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations

FR(1)