NCT06271317

Brief 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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress76%
Mar 2024Mar 2027

First Submitted

Initial submission to the registry

February 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

February 14, 2024

Last Update Submit

December 20, 2024

Conditions

Obesity

Keywords

Nissen sleeve gastrectomyMorbidity-Fistula-Bariatric surgerySleeve gastrectomy

Outcome Measures

Primary Outcomes (2)

  • Study postoperative morbidity after nissen sleeve gastrectomy in Nantes

    Collection of complications at 30 days post-op (aphagia, valve necrosis, fistula, etc.) and classification according to Dindo-Clavien.

    30 days post operation

  • postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France

    Comparison of Nissen Sleeve Gastrectomy data at 30d post-op (aphagia, valve necrosis, fistula...) with published PMSI sleeve gastrectomy data.

    30 days post operation

Study Arms (2)

Nissen sleeve gastrectomy

Nissen sleeve gastrectomy patients

Sleeve gastrectomy with the data of PMSI

Sleeve gastrectomy with the data of PMSI

Eligibility Criteria

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

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))

You may qualify if:

  • 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))

You may not qualify if:

  • Subject unable to read or/and write
  • Planned longer stay outside the region that prevents compliance with the visit plan
  • Current pregnancy
  • Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass).
  • Previous reflux surgery
  • BMI \> 50 kg / m² for women and \> 45kg / m² for men (dissecting the hiatus region can be a technical challenge in these cases).
  • Barrett oesophagus and esophagitis stage III and IV.
  • Funditis
  • No affiliation at the French social security scheme.
  • Major protected by law.
  • Deprivation of liberty by judicial or administrative decision. Participation to another clinical research program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nantes

Nantes, 44000, France

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Claire Louis, M.D

CONTACT

0240083022Claire.BLANCHARD@chu-nantes.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 21, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations

FR(1)