Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients

NCT04626232 | Terminated

• 1 other identifier: RECHMPL20_0013
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Severe Obesity; GERD; Bariatric Surgery Candidate; Morbid Obesity

Keywords

Obesity; GERD; Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (21)

• type of fistula Month 1

  Month 1

• severity of fistula Month 1

  Month 1

• type of fistula Month 6

  Month 6

• severity of fistula Month 6

  Month 6

• type of fistula Month 12

  Month 12

Study Arms (2)

N SLEEVE

EXPERIMENTAL

Monocentric, randomized, single-blind controlled trial, with 2 parallel arms (experimental technique versus surgical reference technique).

Procedure: N-SLEEVE technique

SLEEVE

OTHER

The conventional sleeve gastrectomy technique consists of reducing the gastric capacity by removing 2/3 of the stomach by a vertical transection.

Procedure: SLEEVE

Interventions

N-SLEEVE technique PROCEDURE

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).

N SLEEVE

SLEEVE PROCEDURE

SLEEVE Technique : Removal of 2/3 of the stomach

SLEEVE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).
• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Obesity, Morbid; Gastroesophageal Reflux; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: November 12, 2020
• Study Start: September 12, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FR (1)