A new retrospective study has found that Teleflex's Titan SGS™ Stapler significantly reduces post-operative gastroesophageal reflux disease (GERD) rates in patients undergoing sleeve gastrectomy compared to traditional multi-fire staplers. The findings, published in the journal Obesity Surgery, highlight a potential advancement in addressing one of the most persistent complications of the most common weight-loss surgical procedure in the United States.
The retrospective analysis examined 257 patients who underwent robot-assisted sleeve gastrectomy between 2016 and 2023, with all procedures performed by a single surgeon. The study compared outcomes between patients treated with the Titan SGS™ Stapler and those who received multiple fires of a traditional linear stapler.
Significant Reduction in GERD Rates
At one-year post-procedure, the data revealed striking differences in GERD outcomes between the two cohorts. Only 7.1% of patients in the Titan SGS™ group reported having GERD, compared to 26.4% in the multi-fire group (p = 0.002). The incidence of de novo GERD was also significantly lower in the Titan SGS™ cohort at 1.8%, versus 10.9% in the multi-fire group (p = 0.005).
Furthermore, patients who had GERD prior to surgery were more likely to experience resolution of their condition when treated with the Titan SGS™ Stapler compared to the multi-fire approach (25% vs. 10.9%, p = 0.005).
Importantly, these improvements in GERD outcomes were achieved without compromising weight loss results. Both groups showed similar total weight loss at one year (multiple-fire: 22.4% ± 0.7%, single-fire: 22.0% ± 1.7%, p = 0.8).
Innovative Design Addresses Key Challenges
The Titan SGS™ Stapler is the first and only single-fire surgical stapler specifically designed for sleeve gastrectomy pouch creation. Its unique 23cm continuous staple line—the industry's longest—enables surgeons to create a more consistent tubular sleeve anatomy.
"This study shows that GERD was less common in LSG procedures that used the Titan SGS™ Stapler," said Dr. Forrest Ringold, an expert in bariatric and robotic surgery at the Surgical Association of Mobile and senior researcher on the publication. "I believe this is because the 23cm single-fire Titan SGS™ Stapler is intentionally designed to enable more consistent and symmetrical sleeve anatomy and to provide reproducible pouch anatomies from patient to patient."
The findings address a significant concern in sleeve gastrectomy procedures. While sleeve gastrectomy has become the dominant bariatric surgical approach due to its effectiveness and relatively low complication rates, post-operative GERD remains a persistent challenge. A 2024 review of 109 studies identified "a persistent concern for worsening and de novo GERD" following the procedure.
Mechanism Behind Improved Outcomes
The study's authors hypothesize that the improved GERD outcomes may be attributed to the stapler's ability to create a continuous staple line without overlapping staple firings, which "results in less kinking along the sleeve staple line, which prevents inadvertent narrowing."
This theory aligns with previous research showing that pouch shapes based on anatomical landmarks can help reduce GERD incidence. However, traditional approaches using multiple stapler fires often yield inconsistent pouch anatomy. One study found that bariatric surgeons have been able to achieve the ideal tubular sleeve anatomy less than 40% of the time using conventional methods.
"The Titan SGS™ Stapler was developed to enable more consistent and symmetrical sleeve anatomy because we believe that sleeve shape significantly contributes to sleeve gastrectomy efficacy and safety outcomes," said James Ferguson, President and General Manager, Surgical, at Teleflex.
Additional Clinical Benefits
Beyond GERD reduction, previous retrospective studies have associated the Titan SGS™ Stapler with other clinical advantages, including significantly reduced operative times, less post-operative nausea and vomiting, and potential for increased operational efficiencies with significant reductions in hospital length of stay and readmissions.
These findings could have significant implications for the estimated 250,000 sleeve gastrectomy procedures performed annually in the United States. As obesity rates continue to rise globally, improving outcomes and reducing complications from bariatric surgery becomes increasingly important for public health.
Study Limitations and Future Directions
While the results are promising, it's worth noting that this was a retrospective study with procedures performed by a single surgeon. Additional prospective, multi-center studies would help further validate these findings across diverse surgical settings and patient populations.
The study adds to a growing body of evidence supporting the potential benefits of standardized approaches to sleeve gastrectomy that prioritize consistent sleeve anatomy. As bariatric surgery continues to evolve, innovations that address post-operative complications like GERD may help improve patient satisfaction and long-term outcomes.
For patients considering sleeve gastrectomy, these findings suggest that surgical technique and equipment choice may significantly impact their post-operative quality of life, particularly regarding reflux symptoms that can be debilitating when not properly managed.
