💬In plain words
What the trial is, and whether it could suit you
Laparoscopic sleeve gastrectomy (LSG) has become an increasingly popular bariatric procedure since its first performance by Hess and Hess in 1988 as a component of the biliopancreatic diversion-duodenal switch (BPD-DS) procedure, which was modified from Scopinaro's biliopancreatic diversion (BPD) and DeMeester's technique. In the early part of the twenty-first century, it was popularized as a first-step intervention before BPD or gastric bypass in the super obese and high-risk group of patients by Regan et al. Due to the unexpected good results in terms of weight loss and resolution of comorbidities, coupled with the simplicity of performing the procedure requiring intervention on only the stomach, sleeve gastrectomy gained status as a stand-alone bariatric procedure as demonstrated by Baltasar et al.
The basic principle of LSG is to create a narrow stomach along the lesser curvature, d
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Adult patients aged between 18 and 70 years undergoing LSG as a primary bariatric procedure
2. Body mass index (BMI) criteria according to 2022 ASMBS/IFSO guidelines:
* BMI ≥35 kg/m² regardless of presence, absence, or severity of comorbidities, OR
* BMI 30-34.9 kg/m² (Class I obesity) with metabolic disease and inadequate response to nonsurgical methods, including:
* Type 2 diabetes mellitus
* Arterial hypertension
* Dyslipidemia
* Obstructive sleep apnea syndrome and other severe respiratory disorders
* Cardiovascular disease (coronary artery disease, heart failure, atrial fibrillation)
* Asthma
* Fatty liver disease and nonalcoholic steatohepatitis
* Chronic kidney disease
* Polycystic ovarian syndrome
* Infertility
* Pseudotumor cerebri
* Bone and joint diseases
3. Decision for bariatric surgery approved after multidisciplinary team discussion
4. Written informed consent obtained
5. Ability to complete questionnaires and attend follow-up visits
6. Stable weight (±5% for 3 months before surgery)
7. Normal preoperative upper gastrointestinal endoscopy or findings limited to:
* Los Angeles (LA) Classification Grade A reflux esophagitis (minimal mucosal breaks \<5mm)
* Mild gastritis without active ulceration
8. Negative or minimal gastroesophageal reflux symptoms (GERD-Q score ≤8)
Exclusion Criteria:
1. History of previous gastric surgeries or bariatric procedures
2. American Society of Anesthesiologists (ASA) score \>4
3. Ongoing pregnancy or planned pregnancy within the study period
4. Significant esophageal and gastric pathology, including:
* Los Angeles (LA) Classification Grade B, C, or D reflux esophagitis
* Hiatal hernia or any paraesophageal hernia
* Barrett's esophagus of any length
* Active peptic ulcer disease
* Gastric polyps \>1cm or suspicious lesions
5. Severe gastroesophageal reflux disease is defined as:
* GERD-Q score \>8
* Daily proton pump inhibitor (PPI) dependency with breakthrough symptoms
* Endoscopic evidence of LA Grade B, C, or D esophagitis
6. Coagulation disorders or anticoagulation therapy that cannot be safely discontinued
7. Known silicon hypersensitivity or allergies to bougie materials
8. Active substance abuse or psychiatric conditions that may impair compliance
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