Multisite study of Titan SGS stapler in longitudinal gastric resection

Area of Science:

• Bariatric Surgery
• Surgical Innovation
• Gastrointestinal Surgery

Background:

• Standardization of laparoscopic sleeve gastrectomy is crucial for enhancing patient outcomes.
• A novel single-fire 23 cm stapler, the Titan SGS, was developed to simplify the procedure.
• Ex vivo testing showed the Titan SGS stapler outperformed existing devices in staple line integrity and burst pressure.

Purpose of the Study:

• To evaluate the safety and efficacy of the Titan SGS stapler in creating longitudinal gastric resections in human patients.
• To assess the device's performance in a clinical setting for sleeve gastrectomy.

Main Methods:

• Sixty-one patients undergoing gastric resection with the Titan SGS stapler were enrolled.
• Perioperative data and postoperative adverse events were meticulously recorded.
• Upper GI studies and a 6-week follow-up were conducted to monitor for subacute device-related complications.

Main Results:

• Surgeons reported positive feedback on intraoperative device handling and postoperative gastric pouch shape.
• Adverse events were generally mild, transient, and consistent with known bariatric surgery effects.
• One instance of postoperative hemorrhage necessitated surgical intervention, though no specific bleeding source was identified.

Conclusions:

• The Titan SGS stapler demonstrates both safety and effectiveness for creating the gastric pouch in sleeve gastrectomy procedures.
• The device represents a promising advancement in surgical tools for bariatric surgery.