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

• ClinicalTrials.gov Identifier: NCT04626232
• Recruitment Status: Terminated
• First Posted: November 12, 2020
• Last Update Posted: May 3, 2024
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Tracking Information

• First Submitted Date: October 8, 2020
• First Posted Date: November 12, 2020
• Last Update Posted Date: May 3, 2024
• Actual Study Start Date: September 12, 2022
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 10, 2020)

• Presence of gastroesophageal reflux disease [ Time Frame: 12 months ]
  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
• Consumption of Proton Pump Inhibitor [ Time Frame: 12 months ]
  The consumption of PPI, revealing the presence of GERD symptoms, will be recorded at each visit thanks a diary card.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 10, 2020)

• type of fistula Month 1 [ Time Frame: 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.
• severity of fistula Month 1 [ Time Frame: Month 1 ]
  The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu)
• type of fistula Month 6 [ Time Frame: 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.
• severity of fistula Month 6 [ Time Frame: Month 6 ]
  The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu)
• type of fistula Month 12 [ Time Frame: 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.
• severity of fistula Month 12 [ Time Frame: Month 12 ]
  The severity of fistula is classified depending on the classification of Montpellier 2013 (Nedelcu)
• Postoperative morbidity Month 1 [ Time Frame: Month 1 ]
  Assessed by the type of postoperative complication
• Postoperative morbidity Month 6 [ Time Frame: Month 6 ]
  Assessed by the frequency of each type of postoperative complication
• Postoperative morbidity Month 12 [ Time Frame: Month 12 ]
  Assessed by the severity of each type of postoperative complication
• Weight loss Month 1 [ Time Frame: 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.
• Weight loss Month 6 [ Time Frame: 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.
• Weight loss Month 12 [ Time Frame: 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.
• mortality Month 1 [ Time Frame: Month 1 ]
  number of death
• mortality Month 6 [ Time Frame: Month 6 ]
  number of death
• mortality Month 12 [ Time Frame: Month 12 ]
  number of death
• Quality of Life Month 1 : SF 12 [ Time Frame: Month 1 ]
  Quality of life will be assessed by the self-questionnaire SF12
• Quality of Life Month 6 : SF 12 [ Time Frame: Month 6 ]
  Quality of life will be assessed by the self-questionnaire SF12
• Quality of Life Month 12 : SF 12 [ Time Frame: Month 12 ]
  Quality of life will be assessed by the self-questionnaire SF12
• Serious adverse event Month 1 [ Time Frame: Month 1 ]
  number and type of adverse events
• safety Month 6: number and type of adverse events [ Time Frame: Month 6 ]
  number and type of adverse events
• safety Month 12: number and type of adverse events [ Time Frame: Month 12 ]
  number and type of adverse events

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• Severe Obesity
• GERD
• Bariatric Surgery Candidate
• Morbid 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).
• Procedure: SLEEVE
  SLEEVE Technique : Removal of 2/3 of the stomach

Study Arms

• Experimental: N SLEEVE
  Monocentric, randomized, single-blind controlled trial, with 2 parallel arms (experimental technique versus surgical reference technique).
  Intervention: Procedure: N-SLEEVE technique
• SLEEVE
  The conventional sleeve gastrectomy technique consists of reducing the gastric capacity by removing 2/3 of the stomach by a vertical transection.
  Intervention: Procedure: SLEEVE

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 2, 2024): 2
• Original Estimated Enrollment (submitted: November 10, 2020): 144
• Actual Study Completion Date: November 30, 2022
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04626232
• Other Study ID Numbers: RECHMPL20-0013 PROM 7925
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Montpellier
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Montpellier
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Hospital, Montpellier
• Verification Date: May 2024