Laparoscopic sleeve gastrectomy (LSG), although a relatively simple procedure, often results in resultant sleeve pouch size and shape variability. Standard Clamp (SC), a hand-held stapling guide, has previously shown to result in fewer staple cartridges wasted. In this study, we aimed to demonstrate SC efficacy through fluoroscopic appearance of the resultant sleeve and patient outcomes.
A prospective, single-center, single-surgeon, randomized controlled study was conducted to compare LSG with SC (n=21) to routine LSG without SC (n=18). Upper gastrointestinal fluoroscopy was performed post-operatively and read by four independent radiologists to measure specific sleeve parameters (upper, mid-sleeve, lower sleeve diameter) and classify pouch appearance (tubular, upper pouch, lower pouch, dumbbell). Subjects underwent 2-month and 12-month follow-up to evaluate for weight loss and LSG-related adverse events.
There were no differences in baseline demographics or comorbidities. There were no significant differences (p>0.05) in upper sleeve (2.7 vs 2cm), mid-sleeve (2 vs 1.5cm), lower sleeve (2 vs 2.5cm) diameter as well as sleeves achieving the ideal tubular shape (61.1 vs. 64.7%). Percent total body weight loss at 2-months (-12.2 vs -14.9kg) and 12-month (-22 vs. -25.4kg) were equivalent (p>0.05). There was no difference in adverse events at 2-month follow-up (9.5 vs. 11.1%, p>0.05) nor additional adverse events between 2-month and 12-month follow-up.
The addition of the SC to LSG resulted in equivalent resultant sleeve parameters without adversely impacting short and long-term patient outcomes. Future studies should be conducted to evaluate SC use for standardization of surgical technique across multiple surgeons.