Gastroesophageal Reflux Disease (GERD)
Conditions
Brief summary
The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique), intends for decrease the rate of gastroesophageal reflux disease (GERD). This study aims to evaluate the influence of the Nissen Sleeve technique on GERD. However, the Ezisurg easyEndoTM Linear Cutting Stapler and Loading Units for Single Use were used in this study, and its safety and performance could be evaluated at the same time.
Interventions
PROCEDUREEzisurg stapler SLEEVE technique
The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique)
PROCEDUREEthicon Stapler SLEEVE technique
The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique)
Sponsors
University Hospital, Montpellier
Ezisurg Medical Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Body Mass Index (BMI) ≥ 30 kg/m² (or BMI ≥ 27 kg/m² with at least one obesity-related comorbidity, e.g., type 2 diabetes, hypertension, dyslipidemia). * Medically eligible for laparoscopic sleeve gastrectomy (LSG) or Nissan sleeve surgery, as determined by a multidisciplinary bariatric team (e.g., surgeon, endocrinologist, dietitian). * Ability to understand and voluntarily sign written informed consent. * Willingness to comply with post-operative follow-up protocols (e.g., dietary monitoring, clinical visits, laboratory tests).
Exclusion criteria
* BMI \< 30 kg/m² (or \< 27 kg/m² without obesity-related comorbidities). * Contraindications to laparoscopic surgery (e.g., severe abdominal adhesions, hemodynamic instability, uncorrected coagulopathy). * History of major gastrointestinal surgery (e.g., gastric bypass, colectomy) or anatomical abnormalities precluding sleeve gastrectomy. * Active or uncontrolled chronic diseases (e.g., end-stage renal disease, cirrhosis, metastatic cancer, severe cardiovascular disease). * Psychiatric disorders limiting adherence to post-operative care (e.g., severe depression, psychosis, substance use disorder). * Pregnancy or breastfeeding (or plans for pregnancy within 12 months post-surgery). * Allergy or intolerance to surgical materials, anesthesia, or post-operative medications required for the study. * Inability to communicate or cooperate with study procedures (e.g., language barriers, cognitive impairment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of patients with GERD at 24 months | 24 months | The main objective of the study was to evaluate the impact of Sleeve Gastrectomy procedure with a Nissen fundoplication (Nissen-Sleeve) on the rate of patients with GERD at 24 months. |
Secondary
| Measure | Time frame |
|---|---|
| Intra-operation incidents | Perioperative/Periprocedural |
| Hospital stays | Perioperative/Periprocedural |
| Rate of re-intervention | two-year |
| Surgery time | Perioperative/Periprocedural |
| One-year Endoscopy finding | One-year |
| Early & Long term post-operative complication | two-year |
| Rate of re-hospital | two-year |
Countries
France
Outcome results
None listed