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CHAPTER 27 Simulator-based Training of NOTES Procedures

https://t.me/med1917

motor

max 29 DC

Maxon RE-

Inlet for flexible

endoscope

Figure 27.13 A schematic diagram of the VR -NOTES haptic hardware interface.

Gear box

Friction rollers

Slot for power/si

Maxon RE-

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Maxon RE-

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max 21 DC

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nal cables

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NOTES: Possibilities for the Future

Alexander Aurora & Jeffrey L. Ponsky

University Hospitals, Case Medical Center, Cleveland, OH, USA

Introduction

The introduction of the concept of natural oriﬁ ce surgery by Kalloo in 2004 created excitement and great hope for a new type of surgery that would provide less pain, quicker recovery, and improved cosmesis for patients. In large part supported by industry in hopes of reproducing the dramatic success of laparoscopic cholecystectomy, early research in animal models demonstrated the feasibility of the concept. Early human work ﬁ rst dealt with abdominal exploration and later with high -volume extirpative procedures such as transvaginal and transgastric cholecystectomy and appendectomy. While these approaches were demonstrated to be safe and effective, they were also laborious, time consuming, and costly. Additionally, the method suffered from lack of solution to basic technical problems like suturing, anastomosis, and hemostasis. Clearly, the technology available was not sufﬁ cient for the desired maneuvers. While many early enthusiasts may have lost faith, there have been major contributions of NOTES to current surgical practice and to the technology facilitating that practice. The most obvious of such developments is single -site surgery, which was inspired by NOTES and which utilizes numerous tools developed for NOTES procedures. Continued development and reﬁ nement of technology as well as application of NOTES to more appropriate procedures may lead to widespread use of the method in the future.

The future

The ﬁ rst procedure suggested by Kalloo for the performance of NOTES was transgastric gastrojejunostomy. The procedure was performed in a porcine model. The appeal of this

method was that palliation of impending duodenal obstruction could be achieved per os without the need for laparotomy. Limiting the application of the method was the need for creation of a sutured anastomosis between the stomach and small bowel, which was time consuming and technically challenging. The original concept envisaged by Kalloo in 2004, transgastric gastroenterostomy for palliation of malignant proximal bowel obstruction, has been revitalized with new endoscopic suturing devices. The new anastomotic devices can be delivered endoscopically, are easily deployed, and can quickly produce a secure anastomosis. Currently, there are two endoscopic suturing devices available: OverStitch™ (Apollo Endosurgery, Inc., Austin, TX, USA) and the Tissue Apposition System (TAS, Ethicon Endosurgery, Cincinnati, OH, USA). Endoscopic sutured closure is already feasible and alternate strategies are being pursued [1]. A new closure device in development uses a self -locking stitch (barbed stitch) ﬁ xed to a notched straight needle, which is then delivered through the endoscope with a unique grasping device (Figure 28.1). A sutured closure of bowel/stomach defects can be performed by a relatively simple push -pull movement with one hand and no knot tying.

NOTES has developed new ways to address old problems. It has been employed for abdominal exploration and for replacement of prematurely removed feeding tubes [2]. NOTES continues to address new disease processes, for example esophageal atresia repair via the transesophageal approach. In brief, the endoscope is introduced through the proximal esophagus, which is then perforated; the scope enters the mediastinum to ﬁ nd the distal end (Figure

28.2). The distal esophagus is grasped and then can be approximated to the proximal end, or potentially a stent may be placed to bridge the gap. Atresias of the esophagus and duodenum in newborns may be approached in this manner, obviating the need for major surgery. Similarly,

Natural Oriﬁ ce Translumenal Endoscopic Surgery (NOTES): Textbook and Video Atlas, First Edition. Edited by Anthony N. Kalloo, Jacques Marescaux,

Ricardo Zorron.

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CHAPTER 28 NOTES: Possibilities for the Future

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Figure 28.2 The needle -knife is used to exit the blind proximal pouch and enter the distal pouch. (Based on original artwork by Ana M. Costache.)

Figure 28.1 Barbed suture may facilitate tissue approximation. (Based on original artwork by Ana M. Costache.)

endoscopically guided placement of an intralumenal self expanding, self -ﬁ xing, resorbable covered stent may be employed to form bowel anastomosis (Figure 28.3). The Talon TL stent has eagle -like talons, which help ﬁ x the stent in place on deployment. The resorbable stent makes a bridge across the bowel defect, creating a surface for the bowel to epithelialize over before it degrades in 6 –8 weeks ’ time. Likewise, the concept of endoscopically and endoscopic ultrasound (EUS) guided anastomoses between the biliary tree (gallbladder or bile duct) will be easily accomplished for removal of stones and palliation of malignant obstruction. Transgastric drainage of pancreatic collections is already a reality and is frequently performed. This approach will continue to be reﬁ ned and the use of endoscopic stapling is likely to lead to wider, more permanent anastomoses. Transvisceral drainage of abdominal collections will also become more frequent.

NOTES approaches to thoracic collections (via the esophagus) have already been performed and are likely to become a frequent approach. Similarly, transtracheal mediastinal exploration and pericardial window has been performed with excellent outcomes [3].

In the future the use of the NOTES approach for intraperitoneal exploration is likely to increase, particularly as technology for tissue retraction and hemostasis is improved.

Figure 28.3 A self -expanding stent may be used to bridge a gap and create an anastomosis. (Based on original artwork by Ana M. Costache.)

Hemostasis has remained an impediment to assuring safety in NOTES procedures. Recent advances in experience with bleeding and its management in animal models hold promise. Shi et al. have described the safety of NOTES wedge resection of the liver in a porcine model using the Erbe Jet2 system for dissection and hemoclips and electrocautery for hemostasis [4]. Other groups have developed and demonstrated the efﬁ cacy of hemostatic nanopowder, which can be delivered endoscopically to control small vessel bleeds [5,6].

In the future, the NOTES approach will not exist in a vacuum, but rather will be merged with other endoscopic and laparoscopic methods to provide enhanced therapy with less pain and better cosmesis. Devices that have been developed for use in single -incision laparoscopic surgery (SILS) will be integrated into the NOTES arena, such as the transgastric introduction of the EndoGrab and EndoBar for retraction or magnetic retraction devices.

Speciﬁ cally, development of a stable surgical platform from which to operate and a dependable closure device will

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SECTION 3 Perspectives on NOTES

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catapult NOTES into the mainstream. Recently the over -thescope clip (OTSC) has shown promise as a closure device in the animal model [7]. Other methods have demonstrated potential as effective closure techniques. COSEAL surgical sealant (Baxter, Deerﬁ eld, IL, USA) was used to close tracheal openings after transtracheal mediastinal exploration in dogs [3]. The self -approximating translumenal access technique (STAT) for accessing the peritoneal cavity via the transgastric approach provides reliable closure. In this technique a long submucosal tunnel is dissected for more than 10 cm before entering the peritoneal cavity [8]. These methods are currently being tested for their value in transgastric surgery closure. Similarly, transesophageal access has been used to perform esophageal myotomies in a series of 17 patients with achalasia [9]. In per -oral esophageal myotomy (POEM), after esophageal transmucosal access, the inner circular muscle layer of the distal esophagus and lower esophageal sphincter is incised, while avoiding hiatal dissection and disruption of the phrenoesophageal ligament, which occurs during standard laparoscopic Heller myotomy. The mucosal tunnel collapses on itself and the opening is approximated with endoscopic clips. Similarly, the totally endoscopic anti -reﬂ ux procedure has been trialed and will become more widely available.

Recently, hybrid transvaginal living donor nephrectomy in humans [10] and NOTES transgastric inguinal hernia repair in a canine model [11] have been performed, demonstrating the ever -expanding ﬁ eld of NOTES. Available devices are the TransPort multichannel access device (USGI Medical, Inc., San Clemente, CA, USA), Anubis (Karl Stortz, Tuttlingen, Germany), EndoSAMURAI (Olympus, Tokyo, Japan), and Direct Drive Endoscopic System (Boston Scientiﬁ c, Natick, MA, USA), all of which are in development or soon to be released. A new tri -scope in development can be delivered as a normal endoscope with a retractable sheath (Figure 28.4). Once in the peritoneal cavity per gastric access, the sheath is retracted and the scope opens to deliver three separate arms triangulating in front of the operative target. Each arm has a light and instrument channel. With three functional arms, there is grasping, cutting, and coagulation ability all in one.

Transvaginal surgery is currently the best platform for NOTES, which allows surgeons to approach intra -abdominal organs in a more familiar fashion to standard laparoscopy using standard rigid or newer ﬂ exible/bent instruments and standard laparoscopes [12]. The vaginal approach has demonstrated its efﬁ cacy and safety, ease of approach, and closure without adverse consequence. The obvious drawback is its limitation to use in the female population only. Alternatively, some consider transumbilical surgery as a natural oriﬁ ce through which NOTES is practiced. This is an equally important mode of access similar to that of transvaginal access but its drawback is that it violates the abdominal wall and is associated with postoperative abdominal wall pain.

Figure 28.4 Future iterations of the ﬂ exible endoscope may provide multiple independent arms. (Based on original artwork by Ana M. Costache.)

The development of longer (50 cm) instruments and scopes makes transumbilical NOTES surgery a very appealing mode that is of equivalent utility in both males and females. The transumbilical approach obviates the problem of adequate closure of the access port similar to vaginal access.

In the early days of NOTES there was concern for infection after transvisceral approach. These concerns have largely been dampened from experience with transvaginal access and the use of peri -operative antibiotics. However, there is still considerable concern for complications speciﬁ c to NOTES access, with bladder, ureter, bowel, and vascular injuries having been documented. As experience is gained in NOTES, surgeons must be cognizant of the anatomy surrounding these unfamiliar points of access and recognize the changes in spatial orientation that may lead to complications.

Before NOTES can become mainstream there are some hurdles to be overcome. However, we are well on our way, with an army of surgeons and endoscopists around the world working on better, safer ways to perform NOTES. The key is to maintain the highest degree of safety for our patients and share the wealth of our experience with the international community. NOTES should be practiced and encouraged in well -controlled environments. These skills will need to be developed in both old and new physicians.

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To this end, the American Society for Gastrointestinal Endoscopy (ASGE) skills centers in partnership with surgical training centers such as the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) will provide training in advanced endoscopy and NOTES to promulgate new skills and prepare for the future of surgery and endoscopy. Preceptorships and fellowships for aspiring surgeons and therapeutic endoscopists who wish to master the future avenues of natural oriﬁ ce surgery will become available. These training centers, sponsored by gastrointestinal and surgical societies along with the support of industry, will forge the future of NOTES.

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scopic wedge hepatic resection with a water -jet hybrid knife in a non -survival porcine model . World J Gastroenterol 2011; 17(7):926–31.

5 Giday SA, Kim Y, Krishnamurty DM, et al. Long-term rand-

omized controlled trial of a novel nanopowder hemostatic agent (TC-325) for control of severe arterial upper gastrointestinal bleeding in a porcine model . Endoscopy 2011;43(4):296–9.

6 Sung JJ, Luo D, Wu JC, et al. Early clinical experience of the

safety and effectiveness of Hemospray in achieving hemostasis in patients with acute peptic ulcer bleeding . Endoscopy 2011; 43(4):291–5.

7 Voermans RP , van Berge Henegouwen MI, Bemelman WA ,

Fockens P. Hybrid NOTES transgastric cholecystectomy with reliable gastric closure: an animal survival study . Surg Endosc 2011;25(3):728–36.

8 Mathew A, Tomasko JM, Pauli EM, et al. Reliability of

gastric access closure with the self -approximating transluminal access technique (STAT) for NOTES . Surg Endosc 2011;25(8): 2718–24.

9 Inoue H, Minami H, Kobayashi Y,et al. Peroral endoscopic

myotomy (POEM) for esophageal achalasia . Endoscopy 2010; 42:265–71.

10 Alcaraz A, Musquera M, Peri L, et al. Feasibility of transvaginal

natural oriﬁ ce transluminal endoscopic surgery -assisted living donor nephrectomy: is kidney vaginal delivery the approach of the future? Eur J Urol 2011;59(6):1019–25.

11 Sherwinter DA, Gupta A, Eckstein JG. Natural oriﬁ ce

translumenal endoscopic surgery inguinal hernia repair: a survival canine model . J Laparoendosc Adv Surg Tech 2011;21(3): 209–13.

12 Santos BF , Hungness ES. Natural oriﬁ ce translumenal endo-

scopic surgery: progress in humans since White Paper . World J Gastroenterol 2011;17(13):1655–65.

311

Index

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Page numbers in italics denote ﬁ gures, those in bold denote tables.

abdominal insufﬂ ation 43–4, 44, 44

access ports 43

gastric 44

access routes 39–58, 41

complications 44

planning 40–1

safety 12

single-port see single-port surgery

spillage control 41–2, 43

technical considerations 41

types of access 41

veterinary NOTES 219–21

laparoscopic monitoring 221, 221

transgastric 219–20, 219

transvaginal 220, 220