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

Eric Pauli, Conor P. Delaney, Bradley Champagne, Sharon Stein, Jeffrey M. Marks

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)594-599
Number of pages6
JournalSurgical Innovation
Volume20
Issue number6
DOIs
StatePublished - Dec 1 2013

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Sutures
Safety
Equipment and Supplies
Colectomy
Bites and Stings
Intraoperative Complications
Endoscopy
Colon
Wounds and Injuries

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Pauli, Eric ; Delaney, Conor P. ; Champagne, Bradley ; Stein, Sharon ; Marks, Jeffrey M. / Safety and effectiveness of an endoscopic suturing device in a human colonic treat-and-resect model. In: Surgical Innovation. 2013 ; Vol. 20, No. 6. pp. 594-599.
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abstract = "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.",
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Safety and effectiveness of an endoscopic suturing device in a human colonic treat-and-resect model. / Pauli, Eric; Delaney, Conor P.; Champagne, Bradley; Stein, Sharon; Marks, Jeffrey M.

In: Surgical Innovation, Vol. 20, No. 6, 01.12.2013, p. 594-599.

Research output: Contribution to journalArticle

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N2 - 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.

AB - 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.

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