Clinical trial NCT04626232: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Severe Obesity
GERD
Bariatric Surgery Candidate
Morbid Obesity
Keywords: Obesity
GERD
Surgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Presence of gastroesophageal reflux disease
timeFrame: 12 months
measure: Consumption of Proton Pump Inhibitor
timeFrame: 12 months
Secondary outcomes:
measure: type of fistula Month 1
timeFrame: Month 1
measure: severity of fistula Month 1
timeFrame: Month 1
measure: type of fistula Month 6
timeFrame: Month 6
measure: severity of fistula Month 6
timeFrame: Month 6
measure: type of fistula Month 12
timeFrame: Month 12
measure: severity of fistula Month 12
timeFrame: Month 12
measure: Postoperative morbidity Month 1
timeFrame: Month 1
measure: Postoperative morbidity Month 6
timeFrame: Month 6
measure: Postoperative morbidity Month 12
timeFrame: Month 12
measure: Weight loss Month 1
timeFrame: Month 1
measure: Weight loss Month 6
timeFrame: Month 6
measure: Weight loss Month 12
timeFrame: Month 12
measure: mortality Month 1
timeFrame: Month 1
measure: mortality Month 6
timeFrame: Month 6
measure: mortality Month 12
timeFrame: Month 12
measure: Quality of Life Month 1 : SF 12
timeFrame: Month 1
measure: Quality of Life Month 6 : SF 12
timeFrame: Month 6
measure: Quality of Life Month 12 : SF 12
timeFrame: Month 12
measure: Serious adverse event Month 1
timeFrame: Month 1
measure: safety Month 6: number and type of adverse events
timeFrame: Month 6
measure: safety Month 12: number and type of adverse events
timeFrame: Month 12
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
References: