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New treatment option for Bariatric Sleeve Gastrectomy
Official title Bougie Diameter on Outcomes in Laparoscopic Sleeve Gastrectomy
ClinicalTrials.gov ID: NCT07230769
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Adult patients aged between 18 and 70 years undergoing LSG as a primary bariatric procedure
- 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
You likely can't join if
- History of previous gastric surgeries or bariatric procedures
- American Society of Anesthesiologists (ASA) score \>4
- Ongoing pregnancy or planned pregnancy within the study period
- Significant esophageal and gastric pathology, including:
- Los Angeles (LA) Classification Grade B, C, or D reflux esophagitis
- Hiatal hernia or any paraesophageal hernia
See the full eligibility criteria
- Adult patients aged between 18 and 70 years undergoing LSG as a primary bariatric procedure
- 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
- Decision for bariatric surgery approved after multidisciplinary team discussion
- Written informed consent obtained
- Ability to complete questionnaires and attend follow-up visits
- Stable weight (±5% for 3 months before surgery)
- 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
- Negative or minimal gastroesophageal reflux symptoms (GERD-Q score ≤8)
- History of previous gastric surgeries or bariatric procedures
- American Society of Anesthesiologists (ASA) score \>4
- Ongoing pregnancy or planned pregnancy within the study period
- 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
- 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
- Coagulation disorders or anticoagulation therapy that cannot be safely discontinued
- Known silicon hypersensitivity or allergies to bougie materials
- Active substance abuse or psychiatric conditions that may impair compliance
The study team makes the final eligibility decision.
Where it's taking place
- Alexandria, Alexandria Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alexandria, Alexandria Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.