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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04626232
Other study ID # RECHMPL20-0013 PROM 7925
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 12, 2022
Est. completion date November 30, 2022

Study information

Verified date May 2024
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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Study Design


Intervention

Procedure:
N-SLEEVE technique
The N-SLEEVE technique (figure 2) consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique).
SLEEVE
SLEEVE Technique : Removal of 2/3 of the stomach

Locations

Country Name City State
France CHU Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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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