An interventional study of N-SLEEVE technique and SLEEVE in Severe Obesity, GERD and Bariatric Surgery Candidate, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
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
Bariatric surgery is recognized as the only effective therapeutic weapon for morbidly obese patients. Gastro-Oesophageal Reflux Disease is very common (30-45% of cases) with serious consequences on the oesophageal mucosa. It could be an exacerbation of preoperative GERD symptoms or a "de novo" postoperative GERD. Medical treatment is usually effective but reoperation may be required to treat refractory GERD.GERD can lead to serious consequences on the oesophageal mucosa (esophagitis, Barrett's oesophagus, cancer). The conventional surgical treatment of GERD is fundoplication, which can be partial or total. The gastric fundus is wrapped around the oesophagus to strengthen the tone of the oesophageal sphincter. We hypothesize that the creation of a total anti-reflux fundoplication before performing LSG (Nissen + Sleeve = N-sleeve) could significantly reduce the postoperative GERD complication as compared with the standard LSG.
To evaluate the impact of the procedure N-Sleeve vs conventional sleeve gastrectomy technique on the rate of patient with GERD at 1, 6 and 12 months postoperatively. To evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique during all the follow-up on the gastric fistula on the staple line, on the postoperative morbidity and mortality , on the evolution of weight loss, the excess weight loss, the BMI and the excess BMI loss during the follow-up. Evaluate the impact of these procedures on the quality of life of patients at baseline and 1, 6 and 12 months postoperatively. Evaluate the safety during all the follow-up.
•Methods: Monocentric, randomized, single-blind controlled trial, with 2 parallel arms. 144 patients. The target population is all adult patients with severe or morbid obesity, who underwent multidisciplinary care and having the criteria of 2009 HAS recommendations for bariatric surgery.
Presence of gastro-oesophageal reflux will be assessed by a composite criteria: consumption of Proton Pump Inhibitor and gastroscopy at baseline and 12-month.
The N-SLEEVE technique consists of creating a gastric total fundoplication before to perform the removal of 2/3 of the stomach.
This study may really lead to a change in terms of choice of first intention bariatric procedures.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 2 is below the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Monocentric, randomized, single-blind controlled trial, with 2 parallel arms (experimental technique versus surgical reference technique).
Procedure: N-SLEEVE technique
The conventional sleeve gastrectomy technique consists of reducing the gastric capacity by removing 2/3 of the stomach by a vertical transection.
Procedure: SLEEVE
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 Technique : Removal of 2/3 of the stomach
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
Time frame: 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.
Time frame: 12 months
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.
Time frame: Month 1
severity of fistula Month 1
The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu)
Time frame: Month 1
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.
Time frame: Month 6
severity of fistula Month 6
The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu)
Time frame: Month 6
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.
Time frame: Month 12
severity of fistula Month 12
The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu)
Time frame: Month 12
Postoperative morbidity Month 1
Assessed by the type of postoperative complication
Time frame: Month 1
Postoperative morbidity Month 6
Assessed by the frequency of each type of postoperative complication
Time frame: Month 6
Postoperative morbidity Month 12
Assessed by the severity of each type of postoperative complication
Time frame: Month 12
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.
Time frame: Month 1
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.
Time frame: Month 6
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.
Time frame: Month 12
mortality Month 1
number of death
Time frame: Month 1
mortality Month 6
number of death
Time frame: Month 6
mortality Month 12
number of death
Time frame: Month 12
Quality of Life Month 1 : SF 12
Quality of life will be assessed by the self-questionnaire SF12
Time frame: Month 1
Quality of Life Month 6 : SF 12
Quality of life will be assessed by the self-questionnaire SF12
Time frame: Month 6
Quality of Life Month 12 : SF 12
Quality of life will be assessed by the self-questionnaire SF12
Time frame: Month 12
Serious adverse event Month 1
number and type of adverse events
Time frame: Month 1
safety Month 6: number and type of adverse events
number and type of adverse events
Time frame: Month 6
safety Month 12: number and type of adverse events
number and type of adverse events
Time frame: Month 12
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier