Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Signed informed consent form

• Subjects must be able to attend all scheduled visits and to comply with all trial procedures

• Subjects must be covered by public health insurance

• Contraception efficacy

• Subjects eligible for sleeve gastrectomy after multidisciplinary evaluation according to HAS 2009 criteria: BMI ≥ 40 kg / m² with failure of the dietary treatment for at least 1 year, or a BMI ≥ 35kg / m² with at least one co-morbidity that could be improved after surgery (hypertension, obstructive sleep apnea hypopnea syndrome (OSAHS) and other severe respiratory disorders, severe metabolic disorders (especially type 2 diabetes), debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis (NASH))

Locations
Other Locations
France
CHU Nantes
RECRUITING
Nantes
Contact Information
Primary
Claire Louis, M.D
Claire.BLANCHARD@chu-nantes.fr
0240083022
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2027-03
Participants
Target number of participants: 100
Treatments
Nissen sleeve gastrectomy
Nissen sleeve gastrectomy patients
Sleeve gastrectomy with the data of PMSI
Sleeve gastrectomy with the data of PMSI
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov