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Clinical Trial
. 2009 Jul;23(7):1512-8.
doi: 10.1007/s00464-009-0428-0. Epub 2009 Apr 3.

Natural orifice surgery: initial clinical experience

Santiago Horgan  1 , John P Cullen, Mark A Talamini, Yoav Mintz, Alberto Ferreres, Garth R Jacobsen, Bryan Sandler, Julie Bosia, Thomas Savides, David W Easter, Michelle K Savu, Sonia L Ramamoorthy, Emily Whitcomb, Sanjay Agarwal, Emily Lukacz, Guillermo Dominguez, Pedro Ferraina
Affiliations
Clinical Trial

Natural orifice surgery: initial clinical experience

Santiago Horgan et al. Surg Endosc. 2009 Jul.

Abstract

Background: Natural orifice translumenal endoscopic surgery (NOTES) has moved quickly from preclinical investigation to clinical implementation. However, several major technical problems limit clinical NOTES including safe access, retraction and dissection of the gallbladder, and clipping of key structures. This study aimed to identify challenges and develop solutions for NOTES during the initial clinical experience.

Methods: Under an Institutional Review Board (IRB)-approved protocol, patients consented to a natural orifice operation for removal of either the gallbladder or the appendix via either the vagina or the stomach using a single umbilical trocar for safety and assistance.

Results: Nine transvaginal cholecystectomies, one transgastric appendectomy, and one transvaginal appendectomy have been completed to date. All but one patient were discharged on postoperative day 1 as per protocol. No complications occurred.

Conclusion: The limited initial evidence from this study demonstrates that NOTES is feasible and safe. The addition of an umbilical trocar is a bridge allowing safe performance of NOTES procedures until better instruments become available. The addition of a flexible long grasper through the vagina and a flexible operating platform through the stomach has enabled the performance of NOTES in a safe and easily reproducible manner. The use of a uterine manipulator has facilitated visualization of the cul de sac in women with a uterus to allow for safe transvaginal access.

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Figures

Fig. 1
Fig. 1
No visible scar is seen after laparoscopically assisted transvaginal cholecystectomy
Fig. 2
Fig. 2
The transgastric access port from USGI (San Clemente, CA, USA)
Fig. 3
Fig. 3
The flexible tip of the Novare RealHand grasper (Cupertino, CA)
See this image and copyright information in PMC

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