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

Morbid Obesity Clinical Trial

— NSLEEVE  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04626232
• Other study ID #: RECHMPL20-0013 PROM 7925
• Status: Terminated
• Phase: N/A
• 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
• 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:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• GERD
• Morbid Obesity
• Obesity
• Obesity, Morbid
• Severe Obesity

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