Morbid Obesity Clinical Trial
— NSLEEVEOfficial title:
Monocentric Prospective Randomized Controlled Study Comparing the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique (N-Sleeve) in Morbidly Obese Patients
Verified date | May 2024 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique
Status | Terminated |
Enrollment | 2 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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)) Exclusion Criteria: - 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). - 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 - Long-term NSAIDs and/or corticosteroid therapy - 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of gastroesophageal reflux disease | Gastroscopy is a standard endoscopic examination that examines the lining of the oesophagus and stomach. It can detect Helicobacter pylori and highlight the presence of:
Gastro-Oesophageal Reflux Disease Gastritis Esophagitis Barrett's oesophagus Hiatal hernia Gastric tumor Bile reflux Incompetent cardia |
12 months | |
Primary | Consumption of Proton Pump Inhibitor | The consumption of PPI, revealing the presence of GERD symptoms, will be recorded at each visit thanks a diary card. | 12 months | |
Secondary | type of fistula Month 1 | The diagnosis is confirmed by conducting a CT with contrast medium opacification. 4 stages are defined I, II, III and IV. TDM will be realized only in case of suspicion of fistulas (fever, pain in the left shoulder, vomiting).
The type, the severity and the time between the date of occurrence of fistula and the date of the surgery will be recorded at each visit. |
Month 1 | |
Secondary | severity of fistula Month 1 | The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu) | Month 1 | |
Secondary | type of fistula Month 6 | The diagnosis is confirmed by conducting a CT with contrast medium opacification. 4 stages are defined I, II, III and IV. TDM will be realized only in case of suspicion of fistulas (fever, pain in the left shoulder, vomiting).
The type, the severity and the time between the date of occurrence of fistula and the date of the surgery will be recorded at each visit. |
Month 6 | |
Secondary | severity of fistula Month 6 | The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu) | Month 6 | |
Secondary | type of fistula Month 12 | The diagnosis is confirmed by conducting a CT with contrast medium opacification. 4 stages are defined I, II, III and IV. TDM will be realized only in case of suspicion of fistulas (fever, pain in the left shoulder, vomiting).
The type, the severity and the time between the date of occurrence of fistula and the date of the surgery will be recorded at each visit. |
Month 12 | |
Secondary | severity of fistula Month 12 | The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu) | Month 12 | |
Secondary | Postoperative morbidity Month 1 | Assessed by the type of postoperative complication | Month 1 | |
Secondary | Postoperative morbidity Month 6 | Assessed by the frequency of each type of postoperative complication | Month 6 | |
Secondary | Postoperative morbidity Month 12 | Assessed by the severity of each type of postoperative complication | Month 12 | |
Secondary | Weight loss Month 1 | The evolution of the weight of the patients will be assessed by measuring their weight in kilograms on the same scale at each visit in the digestive surgery service. The height (in meter) will be assessed at baseline in the digestive surgery service. The BMI will be calculated at each visit. | Month 1 | |
Secondary | Weight loss Month 6 | The evolution of the weight of the patients will be assessed by measuring their weight in kilograms on the same scale at each visit in the digestive surgery service. The height (in meter) will be assessed at baseline in the digestive surgery service. The BMI will be calculated at each visit. | Month 6 | |
Secondary | Weight loss Month 12 | The evolution of the weight of the patients will be assessed by measuring their weight in kilograms on the same scale at each visit in the digestive surgery service. The height (in meter) will be assessed at baseline in the digestive surgery service. The BMI will be calculated at each visit. | Month 12 | |
Secondary | mortality Month 1 | number of death | Month 1 | |
Secondary | mortality Month 6 | number of death | Month 6 | |
Secondary | mortality Month 12 | number of death | Month 12 | |
Secondary | Quality of Life Month 1 : SF 12 | Quality of life will be assessed by the self-questionnaire SF12 | Month 1 | |
Secondary | Quality of Life Month 6 : SF 12 | Quality of life will be assessed by the self-questionnaire SF12 | Month 6 | |
Secondary | Quality of Life Month 12 : SF 12 | Quality of life will be assessed by the self-questionnaire SF12 | Month 12 | |
Secondary | Serious adverse event Month 1 | number and type of adverse events | Month 1 | |
Secondary | safety Month 6: number and type of adverse events | number and type of adverse events | Month 6 | |
Secondary | safety Month 12: number and type of adverse events | number and type of adverse events | Month 12 |
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