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

University Hospital Center (CHU)

Status: Terminated

Conditions: Bariatric Surgery Candidate; Morbid Obesity; GERD; Severe Obesity

Treatments: Procedure: N-SLEEVE technique; Procedure: SLEEVE

Study type: Interventional

Funder types: Other

Identifiers

NCT04626232

RECHMPL20_0013

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

N SLEEVE

Experimental group

Description:

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

Treatment:

Procedure: N-SLEEVE technique

SLEEVE

Other group

Description:

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

Treatment:

Procedure: SLEEVE