Safety and effectiveness of an endoscopic suturing device in a human colonic treat-and-resect model.

BACKGROUND: Despite advances in many areas of therapeutic endoscopy, the development of an effective endoscopic suturing device has been elusive. The purpose of this trial was to evaluate the safety and effectiveness of a suturing device to place and secure sutures within normal, in vivo human colonic tissue prior to surgical resection.

METHODS: Patients undergoing elective colectomy were enrolled in this treat-and-resect model. The Overstitch endoscopic suturing device (Apollo Endosurgery, Austin, TX) was used to place sutures in healthy colonic tissue during a 15-minute, time-limited period. Following colectomy, the explanted tissue was evaluated to determine the depth of suture penetration and the effectiveness of the suture/cinch element. Clinical and operative data were recorded.

RESULTS: Four patients (50% female) were enrolled. Seven sutures were successfully placed, incorporating a total of 10 tissue bites in a mean of 13.5 minutes. On inspection of the explanted tissue, all sutures were found to be located subserosal (no full thickness bites were taken). The suture and cinch elements were judged to be effective in the majority of cases. One device-related issue did not inhibit the ability to oppose tissue or place the cinch. There were no intraoperative or postoperative complications.

CONCLUSIONS: The Overstitch permitted safe and effective suturing in an in vivo human colon model. The sutures were placed at a consistent subserosal depth and at no point risked iatrogenic injury to adjacent structures. Technical issues with the device were infrequent and did not inhibit the ability to place sutures effectively.