Добавил:
kiopkiopkiop18@yandex.ru t.me/Prokururor I Вовсе не секретарь, но почту проверяю Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз: Предмет: Файл:

Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_1127_Библиотеки_им_академика_М_И_Перельмана

.pdf
Скачиваний:
0
Добавлен:
02.09.2026
Размер:
20 Мб
Скачать
and mediastinitis and sepsis in one pig. A different approach
https://t.me/med1917
to the thoracic cavity was evaluated by De Palma and colleagues [10]. They reported the feasibility of a transgastric transdiaphragmatic route for lung biopsy in four pigs without postoperative complications. Although many of these expe­riences are still anecdotal, they represent potential areas for future study in this new emerging fi eld. Further explora­tion and feasibility of these approaches will need to be examined.
Transesophageal thoracic surgery
Choosing an access site
The transesophageal access route to the mediastinum and thorax represents the most widely used and accepted approach to thoracic NOTES procedures. The anatomy of the thoracic esophagus and its relationship to the great vessels and other organs in the mediastinum, however, remains one of the biggest challenges of the transesophageal approach. The use of endoscopic ultrasound (EUS), as a guide for determining an ideal access site and as a tool to improve the visualization and localization of targets such as lymph nodes, has been evaluated by Fritscher -Ravens and colleagues in the swine model [11]. In their experience, there were 3 complications in 14 animals without the use of EUS and none in 14 animals with EUS guidance. They also evaluated the use of EUS in abdominal transgastric procedures, and although there were no differences in these, it appeared to be especially useful in mediastinal and thoracic procedures where the anatomy may be more complex and where the mediastinum is enclosed by delicate structures with no virtual space to work within. EUS is a promising guidance tool in transesophageal surgery to help identify either the site of entrance, specifi c targets, or both, especially in humans, where the mediastinum may be anatomically even more complex than in animal models. Nevertheless, there are several reports documenting successful NOTES proce­dures with few complications when transesophageal access to the thoracic cavity is performed in the absence of endosonographic guidance [12,13]. Therefore, although EUS appears to be as an interesting tool, its absolute neces­sity in transesophageal procedures remains unclear based on animal studies to date.
Access technique
Once the site of entrance has been chosen, the esophagus must be opened to gain access into the mediastinum and thorax. Different approaches have been described to traverse the esophageal wall. One approach is to incise the mucosa and muscular layer of the esophagus with a needle -knife to create a full -thickness linear defect in the esophageal wall (Figure 22.1). This provides direct and straightforward
CHAPTER 22 Thoracic Cavity Application of NOTES
Figure 22.1 Full-thickness transesophageal technique. (Reproduced
from Fritscher -Ravens et al. [16], with permission from Georg Thieme Verlag KG.)
access to the mediastinum, but requires a reliable closure technique to prevent leaks and potential subsequent infection.
A second approach to open the esophagus requires the creation of a submucosal tunnel and has been widely described by different authors (Figure 22.2) [12,14,15]. In this technique, the mucosa is fi rst separated from the under­lying muscle layer using injection of a saline solution or a multiband mucosectomy device to incise the esophageal mucosal layer (Figure 22.2). Once the mucosa is divided, a 5–10 cm long tunnel is created using air and blunt dissection with the aid of the endoscope and closed graspers (Figure
22.3). Finally, the muscle layer is incised at the distal end of the tunnel using a needle -knife (Figure 22.4). The main advantage of this tunneling technique appears to be the relative ease of closure, decreased necessity for special sutures and devices, and reduced risk of esophageal leak and infection, which is a major concern with this transesopha­geal approach (Video 22.1).
Closure
Another major challenge of transesophageal NOTES proce­dures is the safety of the esophageal closure to prevent esophageal leak and mediastinal infection. For full -thickness esophageal wall incisions, Fritscher -Ravens and colleagues used two alternatives for closure, stitches or clips, in a small animal series [16]. The necropsy revealed good macroscopic and histologic healing using full -thickness sutures. However, with the use of clips the closure of the muscular layer was incomplete, suggesting clips may not be enough to secure full -thickness closure of the esophageal wall. Perhaps unexpectedly, the use of a submucosal tunnel without the use of closure device has demonstrated excellent results with no evidence of infection [17]. Recently, a prospective,
245
SECTION 3 Perspectives on NOTES
https://t.me/med1917
(a) (b)
(c) (d)
Figure 22.2 Tunneling transesophageal technique. (Reproduced from Turner BG, Gee DW. Natural orifi ce transesophageal thoracoscopic surgery: a review of the current state. World J Gastrointest Endosc 2010; 2(1):3–9, with permission.)
(a) (b)
(c)
Figure 22.3 Endoscopic view of the tunneling technique: (a) mucosa opening, (b) submucosal space, and (c) muscular defect.
randomized trial in the animal model compared the submu­cosal tunnel closure with (fi ve animals) and without (fi ve animals) the use of a covered esophageal stent as an adjunc­tive method of closure [18]. Complete closure of the entrance site was observed in both groups although interference with
246
mucosectomy site healing was observed in four out of fi ve of the stented animals. There were two stent migrations to the stomach and a longer mean procedure time was observed in this group. Contrary to what would be expected, the addi­tion of a stent to the submucosal tunnel technique did not
Lymph node
https://t.me/med1917
CHAPTER 22 Thoracic Cavity Application of NOTES
Sympathetic chain
Figure 22.4 Endoscopic view of the thoracic sympathectomy.
improve esophageal mucosectomy site healing and appears to be unnecessary in animal models.
Applications of thoracic NOTES
Video -assisted thoracic sympathectomy is one of the current surgical alternatives for the treatment of palmar hyper­hidrosis. Turner et al described the feasibility of the trans­esophageal approach for thoracic sympathectomy in a non-survival swine model [12]. The resection of the sympa­thetic chain was confi rmed by biopsy in seven of eight animals with a mean procedure time of 61 minutes (Video
22.2, Figure 22.5). Similarly, endoscopic transesophageal lymphadenectomy of the subcarinal, para -aortic and para ­tracheal lymph nodes has been described in non -survival and survival swine models [13,19]. These studies demon­strate the feasibility of en bloc resection of lymph nodes in an animal model, providing an intact specimen for histologic examination (Video 22.3). Transesophageal thoracic sym­pathectomy and lymphadenectomy are interesting alterna­tives to evaluate in human trials based on their simplicity and good results in animal studies.
While the majority of transesophageal research has focused on pleural or mediastinal procedures, Fritscher ­Ravens et al. and Sumiyama et al. have evaluated the fea­sibility of the transesophageal approach to the pericardium [16,20]. Using a pericardial window to gain access to the pericardial cavity, they performed a spot coagulation of the epicardium in fi ve pigs. The procedure was successfully per­formed in four of fi ve animals without evidence of complica­tions at necropsy. This work opens more areas of NOTES applications in the fi eld of cardiovascular surgery with new opportunities and challenges.
Recently, Rolanda and colleagues reported an interesting and innovative experience of segmental esophagectomy using a hybrid approach in an ex vivo and in vivo animal model [21]. In this preliminary experience, the combination of a rigid transthoracic and oral fl exible endoscopic approach
Figure 22.5 Endoscopic view of the lymph node dissection.
was used to resect a short segment of esophagus and then to perform an end -to-end anastomosis. The procedure was completed in fi ve ex vivo and fi ve in vivo animals. The patency and impermeability of the anastomosis was evaluated in all the procedures and a leak was detected and corrected in three animals. The complexity of the pro­cedure required the use of a combination of endoscopic and thoracoscopic approaches. However, this study represents a fi rst step toward the “hybrid” procedure, which has been used in human NOTES studies thus far and will likely be necessary as a bridge to pure thoracic NOTES procedures as well [22].
Perhaps the most exciting advancement in transesopha­geal NOTES techniques has been the endoscopic esophago­myotomy. In patients with achalasia, surgical management has traditionally been the laparoscopic Heller myotomy. This technique creates a surgical interruption of the lower esophageal sphincter (LES) to alleviate the hypertonicity at the LES. Although the fi rst endoscopic approach for Heller myotomy was described over 30 years ago [23], the develop­ment of the NOTES concept and new endoscopic tools has raised new interest in this area.
In 2007, Pasricha et al. described a transesophageal approach for Heller myotomy in four pigs using a submu­cosal tunnel technique [24]. Manometric evaluation dem­onstrated a signifi cant reduction in LES pressure at fi ve days and absence of infection at necropsy. Three years later, Inoue et al. in 2010 described the fi rst human experience, in the era of NOTES, of transesophageal myotomy for acha­lasia [25]. This report describes a transesophageal myotomy using a submucosal tunnel technique in 17 patients. A sig­nifi cant improvement of symptoms and reduction in resting LES pressures was observed in all cases at short -term follow ­up, fi ve months. There were no postoperative complications, but one patient developed refl ux esophagitis controlled with the use of proton pump inhibitors (PPIs). The authors termed the procedure per -oral endoscopic myotomy (POEM). A second study, of posterior myotomy, published by the same group reproduces the same results in 43 patients [26]. The
247
SECTION 3 Perspectives on NOTES
https://t.me/med1917
promising results of this preliminary clinical experience in terms of safety and effi cacy provide compelling evidence to continue this area of development, evaluate its reproducibil­ity in different centers, and determine its effi cacy at longer follow-up [27]. Additionally, although this technique of endoscopic esophagomyotomy may not be considered an extralumenal procedure, it provides preliminary evidence in humans regarding the safety of the submucosal tunneling technique, lending support to its use in extralumenal trans­esophageal procedures in humans.
Flexible endoscopic thoracic procedures
Although NOTES implies entry via a natural orifi ce, the development of this fi eld has introduced other novel uses of fl exible endoscopy, similar to what occurred at the begin­ning of the laparoscopic surgery revolution with laparoscopic ­assisted open surgery. Indeed, the use of fl exible scopes in more complex translumenal surgical procedures has driven its utilization in thoracic and abdominal procedures, often replacing standard rigid scopes [28,29]. Using a fl exible scope, Spaun et al. described a transcervical approach to circumferentially dissecting the thoracic esophagus, per­forming a LES myotomy, and resecting mediastinal lymph nodes in both swine and human cadavers [30]. Using a small cervical incision and blunt dissection, the fl exible scope was introduced to the mediastinum. The dissection then contin­ued using a pretracheal or pre - or post -esophageal approach depending on the procedure. A second scope in the esopha­gus was used to facilitate its recognition and also monitor mucosal integrity after LES myotomy. Lymph nodes were marked using transoral EUS guidance with black dye or methylene-blue. Overall, 16 out of 16 lymph nodes were successfully harvested in pigs and 2 of 2 in the cadaver with completion of Heller myotomy in all cases. A second article by the same group describes in detail their experience with transcervical Heller myotomy in a survival series of ten pigs and also in two human cadavers [31]. Myotomy was per­formed in all animals and cadavers; it was successfully extended 2 cm to the stomach in all of the four posterior myotomies (three pigs and one cadaver), but only in 25% of the anterior myotomies (two pigs).
A similar concept with a different intended purpose has been described using a subxiphoid approach in animal models and also in patients. Zenati et al. describe a new platform for video pericardioscopy named the FLEXview system (Boston Scientifi c Cardiac Surgery, Santa Clara, CA, USA), which allows visualization and electronic mapping of the epicardium in patients [32]. Manca and colleagues described the use of a subxiphoid approach in patients with pericardial effusion for diagnostic purposes [33]. Recently, Gee and colleagues presented their experience using a sub­xiphoid approach for endoscopic pulmonary vein dissection
in a cadaver model [34]. This group successfully performed pulmonary vein dissection in six cadavers using endoscopic instruments as a fi rst step for pulmonary vein isolation. This approach could potentially be a new alternative for the treatment of atrial fi brillation. Inspired by the concept of NOTES, the use of fl exible endoscopy in transcervical and subxiphoid approaches represents new alternatives in the growing fi eld of endoscopic surgery.
Barriers to practice
One of the main concerns among surgeons and endoscopists regarding transesophageal procedures is related to the risk of leak, infection, and mediastinitis. Bacterial contamination and infection in transgastric procedures appears to be avoid­able using standard conditions of asepsis and antibiotic prophylaxis [35–37]. The use of PPIs may increase the bacte­rial load without a signifi cantly higher risk of infection [35,37]. Surprisingly, the incidence of infections as postop­erative complications in transesophageal NOTES procedures appears to be low in animal models but it remains to be evaluated in human studies.
One of the diffi culties observed in mediastinal and tho­racic NOTES procedures is related to the insuffl ation of air and its hemodynamic consequences. Unlike the abdominal cavity, the rigidity of the thorax may produce physiological changes resulting in pneumothorax or compression of greater vessels, with fatal consequences. Von Delius et al. evaluated the cardiovascular effect of transesophageal medi­astinoscopy in a pig model. They found a signifi cant but minor fall in cardiac index, and, most importantly, tension pneumothorax in three of eight animals with one fatality [38]. This highlights the importance of developing preven­tive strategies to avoid or decrease the deleterious effect of the insuffl ation in the thoracic cavity and monitoring its consequences.
Certainly, the transition of animal experience to human studies is diffi cult. The thoracic anatomy of most animal models is different to human anatomy [39]. The right lung in pigs consists of cranial, middle, caudal, and accessory lobes whereas the left lung is divided into a cranial and caudal lobe. The cranial lobe of the right side is ventilated by the tracheal bronchus, which arises proximal to the main bifurcation of the trachea. The distal portion of the esophagus is located in a virtual space surrounded by the accessory lobe of the right lung. This difference com­pared to human anatomy, combined with a smaller heart in pigs (0.3% of body weight versus 1% in dogs) in relation to its size, provides more space to work in and may artifi cially simplify the performance of distal esophageal procedures in animals. At the same time, this anatomic difference may also allow more risk of communication between the right and left thorax, increasing the risk for signifi cant cardiovascular
248
complications based on increased air pressure in a rigid
https://t.me/med1917
cavity [38].
Finally, another diffi culty experienced in NOTES proce­dures is related to the relative absence of instruments, tech­nology, and platforms specifi cally designed for this purpose. Conventional fl exible scopes and endoscopic instruments are designed for diagnostic or therapeutic upper gastrointes­tinal endoscopy or colonoscopy. The current design accounts for diameter and length of scopes, degrees of fl exibility, angle of vision, and number and diameter of working chan­nels, among other specifi cations. The concept of NOTES has allowed the development of new instruments and platforms. Nevertheless, this development is still in its early stages and most of the new technologies are prototypes that are not widely available [40].
The future of thoracic NOTES
Transesophageal Heller myotomy represents, in many ways, the beginning of the era of human NOTES applications in the thoracic cavity [25]. This procedure demonstrates the safety of transesophageal procedures in humans and breaks some of the main barriers and concerns about the NOTES approach. The successful demonstration of the Heller myotomy in a human model also validates previous work in animal models and provides the foundation for advance­ment of other transesophageal NOTES applications [24].
As discussed in this chapter, there are other applications of NOTES in the thoracic cavity that have been evaluated in animal models and these represent the next areas for human study. As was described for the subxiphoid approach, some of these procedures are very specifi c and may require special instruments or platforms. The transition to human studies has been slow but remains encouraging.
Conclusion
Transesophageal NOTES is a new surgical platform that provides a less invasive alternative to accessing the media­stinum and thoracic cavity. Studies in animal models dem­onstrate its safety and feasibility. Preliminary data on human studies shows promising results in endoscopic esophago­myotomy, which provides a reliable platform for extralume­nal transesophageal procedures. Continued technological advances and new instruments are needed to make trans­esophageal NOTES a viable approach in humans.
Chapter video clips
Video 22.1 Transesophageal tunneling technique. Video 22.2 Transesophageal thoracic lymph node dissection. Video 22.3 Transesophageal thoracic sympathectomy.
CHAPTER 22 Thoracic Cavity Application of NOTES
References
1 Gopaldas RR, Bakaeen FG, Dao TK, et al. Video -assisted thora-
coscopic versus open thoracotomy lobectomy in a cohort of 13,619 patients . Ann Thorac Surg 2010;89:1563–70.
2 Anraku M, Miyata R, Compeau C, Shargall Y. Video -assisted
mediastinoscopy compared with conventional mediastinoscopy: are we doing better? Ann Thorac Surg 2010;89:1577–81.
3 Park BJ. Is surgical morbidity decreased with minimally invasive
lobectomy? Cancer J 2011;17:18–22.
4 Kalloo AN, Singh VK, Jagannath SB, et al. Flexible transgastric
peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity . Gastrointest Endosc 2004;60:114–17.
5 Rattner D, Kalloo A. ASGE/SAGES Working Group on Natural
Orifi ce Translumenal Endoscopic Surgery. October 2005 . Surg Endosc 2006;20:329–33.
6 Yang C, Liu HP , Chu Y, et al. Video. Natural orifi ce transtracheal
evaluation of the thoracic cavity and mediastinum . Surg Endosc 2010;24:2905–7.
7 Liu YH, Chu Y, Liu CY , et al. Feasibility of the transtracheal
approach for the thoracic cavity in a large animal model . Surg Endosc 2011;25:1652–8.
8 Liu YH, Liu HP , Wu YC, Ko PJ. Feasibility of transtracheal surgi-
cal lung biopsy in a canine animal model . Eur J Cardiothorac Surg 2010;37:1235–6.
9 Liu YH, Liu HP , Wu YC, Ko PJ. Feasibility of transtracheal tho-
racoscopy (natural orifi ce transluminal endoscopic surgery) . J Thorac Cardiovasc Surg 2010;139:1349–50.
10 De Palma GD, Siciliano S, Addeo P, et al. A NOTES approach for
thoracic surgery: transgastric thoracoscopy via a diaphragmatic incision in a survival porcine model . Minerva Chir 2010;65: 11–15.
11 Fritscher -Ravens A, Ghanbari A, Cuming T, et al. Comparative
study of NOTES alone vs. EUS -guided NOTES procedures . Endos- copy 2008;40:925–30.
12 Turner BG, Gee DW , Cizginer S, et al. Feasibility of endoscopic
transesophageal thoracic sympathectomy (with video) . Gastroin- test Endosc 2010;71:171–15.
13 Turner BG, Gee DW , Cizginer S, et al. Endoscopic transesopha-
geal mediastinal lymph node dissection and en bloc resection by using mediastinal and thoracic approaches (with video) . Gas- trointest Endosc 2010;72:831–5.
14 Sumiyama K, Gostout CJ, Rajan E, Bakken TA , Knipschield MA.
Transesophageal mediastinoscopy by submucosal endoscopy with mucosal fl ap safety valve technique . Gastrointest Endosc 2007;65:679–83.
15 Willingham FF , Gee DW , Lauwers GY , Brugge WR, Rattner DW .
Natural orifi ce transesophageal mediastinoscopy and thoracos­copy . Surg Endosc 2008;22:1042–7.
16 Fritscher -Ravens A, Patel K, Ghanbari A, et al. Natural orifi ce
transluminal endoscopic surgery (NOTES) in the mediastinum: long-term survival animal experiments in transesophageal access, including minor surgical procedures . Endoscopy 2007;39: 870–75.
17 Turner BG, Cizginer S, Kim MC, et al. Stent placement provides
safe esophageal closure in thoracic NOTES Endosc 2011;25:913–18.
(TM)
procedures . Surg
249
SECTION 3 Perspectives on NOTES
https://t.me/med1917
18 Turner BG, Kim MC, Gee DW , et al. A prospective, randomized
trial of esophageal submucosal tunnel closure with a stent versus no closure to secure a transesophageal natural orifi ce translu­minal endoscopic surgery access site . Gastrointest Endosc 2011;73: 785–90.
19 Woodward T, McCluskey D, 3rd, Wallace MB, et al. Pilot study
of transesophageal endoscopic surgery: NOTES esophagomyot­omy, vagotomy, lymphadenectomy . J Laparoendosc Adv Surg Tech A 2008;18:743–5.
20 Sumiyama K, Gostout CJ, Rajan E, et al. Pilot study of trans-
esophageal endoscopic epicardial coagulation by submucosal endoscopy with the mucosal fl ap safety valve technique (with videos). Gastrointest Endosc 2008;67:497–501.
21 Rolanda C, Silva D, Branco C, et al. Peroral esophageal
segmentectomy and anastomosis with single transthoracic trocar: a step forward in thoracic NOTES . Endoscopy 2011;43: 14–20.
22 Lehmann KS, Ritz JP , Wibmer A, et al. The German Registry for
natural orifi ce translumenal endoscopic surgery: report of the fi rst 551 patients . Ann Surg 2010;252:263–70.
23 Ortega JA, Madureri V, Perez L. Endoscopic myotomy in the
treatment of achalasia . Gastrointest Endosc 1980;26:8–10.
24 Pasricha PJ, Hawari R, Ahmed I, et al. Submucosal endoscopic
esophageal myotomy: a novel experimental approach for the treatment of achalasia . Endoscopy 2007;39:761–4.
25 Inoue H, Minami H, Kobayashi Y, et al. Peroral endoscopic
myotomy (POEM) for esophageal achalasia . Endoscopy 2010;42: 265–71.
26 Inoue H, Kudo SE. [Per -oral endoscopic myotomy (POEM) for
43 consecutive cases of esophageal achalasia] . Nippon Rinsho 2010;68:1749–52.
27 Dotai T, Katagiri T, Nijhawan S, et al. The steps and outcome of
transesophageal endoscopic myotomy . In 2011 Scientifi c Session of the Society of American Gastrointestinal and Endoscopic Sur­geons (SAGES), San Antonio, Texas, USA, 2011 .
28 Parker M, Pfl uke JM, Shaddix KK, et al. Video: transcervical
videoscopic esophageal dissection in minimally invasive esophagectomy . Surg Endosc 2011;25:941–2.
29 Swanstrom LL, Dunst CM, Spaun GO. Future applications
of fl exible endoscopy in esophageal surgery . J Gastrointest Surg 2010;14(suppl 1 ):S127–32.
30 Spaun GO, Dunst CM, Martinec DV , et al. Mediastinal surgery
in connective tissue tunnels using fl exible endoscopy . Surg Endosc 2010;24:2120–27.
31 Spaun GO, Dunst CM, Arnold BN, et al. Transcervical Heller
myotomy using fl exible endoscopy . J Gastrointest Surg 2010;14: 1902–9.
32 Zenati MA, Shalaby A, Eisenman G, et al. Epicardial left ven-
tricular mapping using subxiphoid video pericardioscopy . Ann Thorac Surg 2007;84:2106–7.
33 Manca G, Codecasa R, Valeri A, et al. Totally endoscopic subxi-
phoid pericardioscopy: early steps with a new surgical tool . Surg Endosc 2009;23:444–6.
34 Gee D, Escalona A, Briggs KH, et al. Endoscopic pulmonary vein
ablation for atrial fribrillation: a giant step forward . In 2011 Scientifi c Session of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) San Antonio, Texas, USA,
2011.
35 Giday SA, Dray X, Magno P, et al. Infection during natural orifi ce
transluminal endoscopic surgery: a randomized, controlled study in a live porcine model . Gastrointest Endosc 2010;71: 812–16.
36 Eickhoff A, Vetter S, von Renteln D, et al. Effectivity of current
sterility methods for transgastric NOTES procedures: results of a randomized porcine study . Endoscopy 2010;42:748–52.
37 Memark VC, Anderson JB, Nau PN, et al. Transgastric endo-
scopic peritoneoscopy does not lead to increased risk of infec­tious complications . Surg Endosc 2011;25(7):2186–91.
38 von Delius S, Wilhelm D, Feussner H, et al. Natural orifi ce
transluminal endoscopic surgery: cardiopulmonary safety of transesophageal mediastinoscopy . Endoscopy 2010;42:405–12.
39 Sack WO. Essentials of Pig Anatomy, 1st edn . Veterinary Text-
books, Ithaca, New York , 1982.
40 Karimyan V, Sodergren M, Clark J, Yang GZ, Darzi A. Navigation
systems and platforms in natural orifi ce translumenal endo­scopic surgery (NOTES) . Int J Surg 2009;7:297–304.
250
23
https://t.me/med1917
Designing the NOTES Procedure Room
Mouen A. Khashab & Anthony N. Kalloo
The Johns Hopkins Hospital, Baltimore, MD, USA
Introduction
Natural orifi ce translumenal endoscopic surgery (NOTES) has evolved as a legitimate alternative technique to tradi­tional surgery and laparoscopy for the work -up and treat­ment of various mediastinal [1,2], abdominal [3], and pelvic pathologies [4] since its introduction in 2000 [5]. The improvement in the endoscopic and laparoscopic imaging and technology has made the performance of NOTES surgery become the next logical step. Although multiple challenges have yet to be overcome before the widespread adoption of NOTES [6], the recent immense interest in this technique has led to an increasing number of publications [7], includ­ing well -designed randomized controlled trials [8–11]. Fur­thermore, human NOTES procedures have already been performed and multiple exciting papers detailing this exigent work have also been published [12–16]. Researchers, endo­scopists, and surgeons working in the NOTES fi eld have to toil diligently together for NOTES to move forward.
Most reported human NOTES procedures had been per­formed in conventional operating rooms. Marks et al., however, performed bedside transgastric NOTES to success­fully treat a dislodged percutaneous gastrostomy tube (PEG) in the early postoperative period [17]. Performing NOTES procedures in the endoscopy suite is a new concept and may help expand the scope of NOTES and its widespread use. Hoffman et al. recently showed that mini -laparoscopy­guided liver biopsy performed in an endoscopy unit is a safe technique for the evaluation of patients with liver disease [18]. In this chapter, we propose a design for a modern NOTES room in the endoscopy suite.
General principles
The design and construction of an advanced and minimally invasive NOTES room is a signifi cant undertaking. It is fi rst important to determine the number of NOTES procedures rooms necessary to accommodate the caseload of the unit. This will also be determined by whether these rooms will be dedicated for NOTES procedures only or whether other advanced endoscopic procedures will be performed in these rooms. Approximately 300 sq ft is an adequate space for a traditional endoscopy room [19]. However, ample space is needed for NOTES rooms to accommodate endoscopic, laparoscopic, and radiologic equipment and a minimum of 360 sq ft is likely needed. Strategic equipment placement within this space is essential to optimize the effi ciency and the safety of the unit. (Figure 23.1, Video 23.1).
Power cables from electrosurgical units, IV lines, suction tubing, etc., crowd endoscopy rooms, block access to patients, and may pose a hazard to the endoscopy unit per­sonnel moving about the darkened endoscopy room. Ceiling-mounted equipment booms are being increasingly used in modern operating rooms to eliminate the above shortcomings of the “low tech ” designs. These booms use the space above the false ceiling and consist of articulat­ing arms that support different equipment, such as light source, endocamera, anesthetic gas connections, electrocau­tery, and electric plug points. Ceiling -mounted booms enhance sterile set -up and decrease the risk of cable leakage since they are hidden above the false ceiling. The above ­ceiling space should be of adequate height to include air conditioning pipelines, data relay wires, and cables for
Natural Orifi ce Translumenal Endoscopic Surgery (NOTES): Textbook and Video Atlas, First Edition. Edited by Anthony N. Kalloo, Jacques Marescaux,
Ricardo Zorron.
© 2012 John Wiley & Sons, Ltd. Published 2012 by John Wiley & Sons, Ltd.
251
SECTION 3 Perspectives on NOTES
https://t.me/med1917
(a) (b)
Figure 23.1 Spacious NOTES room with the ability to accommodate endoscopic, laparoscopic, and radiologic equipment. Ceiling -mounted booms enhance sterile set -up, decrease clutter, and ease personnel movement.
various equipment booms (e.g., electrical wires, vacuum, oxygen, etc.).
Lighting
Effective and successful performance within the operating room is enhanced by having lighting that does not cause visual, operational, and environmental diffi culties such as glare, shadowing, or visual stress. The operating room envi­ronment requires a combination of satisfactory ambient lighting and effective direct and indirect task lighting. The ability to adjust these lighting levels and change their char­acteristics allows room staff to be more effi cient. An on ­demand voice -activated lighting system may be ideal. Poor lighting can impact on the patient, through poor performance and impaired effectiveness, which may cause lengthened procedures through uncertainty, or even errors. A backup electric system should be available in the case of power failure. There are typically three basic types of lamps used within an operating room environment: incan­descent, gas discharge, and light emitting diodes (LED). Incandescent and gas discharge lamps have traditionally been the main lamp type, utilizing halogen, tungsten, xenon, and quartz. However, other types of lighting are now emerging onto the market in several forms, particularly LEDs. LED -based surgical lights are quickly replacing halogen models in operating rooms, due to advantages such as superior lighting characteristics, cooler operating tempera­tures, and unlimited life span. Equipment booms for lighting are mostly preferred. In the operative area, the overhead light should be shadowless and be freely moveable in both horizontal and vertical ranges. The light should provide
50 000 to 100 000 lux at the center and 15 000 lux at the periphery [20].
Equally important is the ability to dim the lights since endoscopic procedures require a dimly lit room. Large windows would not be preferred.
Fluoroscopy
A NOTES room may be used for other advanced endoscopic procedures that necessitate the use of fl uoroscopic guidance (e.g., endoscopic retrograde pancreatography, stricture dila­tion, enteral stent placement, etc.). Fluoroscopy is also occa­sionally needed during NOTES procedures for assistance in spatial orientation or other specifi c instances, such as use of NOTES for anterior spinal procedures [21].
Radiation protection necessitates a wall thickness in all directions equivalent to 2 mm of lead. A mobile imaging scanner intensifi er, or C -arm, is needed. The C -arm must be compact and lightweight to allow easy positioning with adequate space to work around and a wide range of motion. The X -ray equipment should satisfy the regulatory standards under clinical use conditions. These include presence of adequate total fi ltration, presence of fl uoroscopy timer, which terminates the exposure or produces an audible signal at the end of a fi ve minute accumulative time interval, and fl uoroscopic exposure rates that do not exceed the regula­tory standards. The C -arm should have a high quality image for quick and precise diagnosis. Image display should be on a high -resolution thin -fi lm transistor (TFT) screen monitor. The data output of the C -arm is best transmitted to a hanging screen monitor to optimize visualization by the operating endoscopist.
252
NOTES ( operating room) table
https://t.me/med1917
The NOTES (operating room) table should be mobile, with electronically controlled hydraulic drive, and with adequate width and weight bearing capability. It must allow for patient positioning in both supine and prone positions, with signifi ­cant amounts of longitudinal or transverse tilts. The table should allow tilt in different directions to be able to move the bowels or other organs out of the “fi eld of view ’ using gravity. The tabletop is divided into multiple sections, includ­ing leg plates for the lithotomy position (for transvaginal NOTES procedures). In addition, the tabletop should be without crossbars for it to be compatible with fl uoroscopy.
Sterilization
There is a basic difference between disinfection and steriliza­tion. While sterilization is a process that destroys all forms of microbial life, disinfection is a process that eliminates most pathogenic microorganisms, with the exception of some bacterial spores and infectious proteins [22]. Maxi­mally aseptic conditions should be used during NOTES pro­cedures [23]. This requires sterilization of endoscopes and all endoscopic accessories, including the use of sterile over­tubes during the passage of the endoscope through the gas­trointestinal tract or other hollow organs [23]. Non -sterile conditions invariably lead to intraperitoneal infection. Aseptic techniques during NOTES prevent intra -abdominal infections [24,25].
A sterilization unit should be in close proximity to the NOTES room. Sterilization techniques for human use include prolonged soaking in high -level sterilant, automated liquid sterilization, gas sterilization using ethylene oxide, and hydrogen peroxide gas vapor sterilization (e.g., STERRAD, Ethicon, Inc., Somerville, NJ, USA). This latter system pro­vides a high level of sterilization within a half an hour processing time and is advisable for units with high -volume load of procedures [20].
NOTES room air pressure
The Centers for Disease Control (CDC) recommends main­tenance of a positive air pressure in operating rooms so that airborne contaminants will not fl ow into the surgical site. To minimize entry of airborne microbes into the NOTES room, systems that maintain air pressure in the room higher by at least 0. 002 inches of water column (0.5 Pascals) than the air pressure in the corridor are used. These systems fi lter the air before delivery with a high effi ciency particulate air (HEPA) fi lter and then pump it into the operating room at high pressure, which forces air from the operating room out
CHAPTER 23 Designing the NOTES Procedure Room
into the hallway. To maintain positive pressure, the room should be well sealed without any loopholes. Excessive posi­tive air pressure is unnecessary because it is energy ineffi ­cient and may push enough moist air into cool wall cavities during cold weather to result in hidden mold growth in the walls.
Laparoscopic equipment
Many advances are needed for pure NOTES procedures to become routine. Hybrid surgery, or laparoscopically assisted NOTES, allows judicious implementation of NOTES tech­niques in patients [26]. As we learn more about NOTES and as the experience with NOTES techniques grows, hybrid operations will likely rely less on laparoscopy and more on pure endoscopy, serving as a transition to broad application of pure clinical NOTES [26].
Laparoscopic equipment should be handy in the NOTES room to assist in hybrid procedures. In addition, laparoscopy is potentially needed to assist in treatment of unexpected complications, such as bleeding and iatrogenic visceral perforation. Laparoscopy can also be used for access closure. Needed laparoscopic surgical equipment can be clas­sifi ed into two broad categories: equipment for access and exposure, and hand instruments for the actual operative procedure.
Laparoscopic equipment for access and exposure
1 A telescope: usually a 10 mm diameter, 25 cm long rod lens for viewing with additional parallel optic fi bers to allow light from an external source. The telescope has an eyepiece for direct viewing or fi xing of a camera and a “side branch ” at right angles to allow the attachment of a light -transmitting cable carrying light from a light source. 2 A laparoscopic “camera”: this is a special lightweight attachment that is fi xed to the eyepiece of the telescope and is able to pick up a video image of whatever is seen in the telescope. The video signal is transmitted to a special video monitor. 3 A high -performance halogen or Xenon light source with a fi ber -optic cable to transmit the light from the light source to the telescope, which has a special attachment point for the light cable. 4 Video monitor: high resolution “medical” monitors display colors more accurately, but are more expensive. However, the less expensive ordinary TV sets can be used for most routine operative work. 5 An insuffl ator: delivers carbon dioxide gas from a high ­pressure cylinder to the patient at a low and accurately controlled pressure and at a high rate if necessary.
6 Cylinder of carbon dioxide gas. 7 Ancillary equipment: cables to connect the monitor to the
camera control unit, a tube to transmit carbon dioxide from
253
SECTION 3 Perspectives on NOTES
https://t.me/med1917
the insuffl ator to the patient, and minor items such as brushes to clean the equipment and telescope anti -fog solution.
Hand instruments for laparoscopic surgery
Hand instruments in laparoscopic surgery include graspers, scissors, needle holders, retractors, clip applicator, trocars, and cannulas. Since most instruments are either 5 –5.5 mm or 10 –11 mm in diameter, 5.5 mm and 11 mm trocars, along with a “reducer” that allows the use of a 5 mm instrument in a 10 mm or 11 mm cannula are needed. A Veress needle may also be used. This is a spring -loaded needle that is used to make a blind fi rst puncture for laparoscopic access into the abdominal cavity. There is a small but unavoidable inci­dence of injury to bowel or great vessels as the insertion of this needle is blind. The use of a Veress needle can be avoided by use of the “open entry ” technique, in which the peritoneal cavity is entered under vision.
Conversion from NOTES to laparoscopic or open procedures
NOTES room should have the necessary provisions to allow conversion of a NOTES procedure to laparoscopic or even an open surgical procedure. This is potentially needed in cases of failed NOTES, unexpected complications, or unex­pected fi ndings. NOTES room staff must be prepared for such conversions without delay. Open retractors and extra ­long open instruments must be available in the room for this possibility. Ideally, an open instrument tray should be avail­able in anticipation of possible urgent open conversion. Con­version to a laparoscopic or open procedure will be part of the learning curve for NOTES operators.
Ergonomics of a NOTES room
Endoscopists report a high rate of injury related to the repet­itive use of endoscopic equipment. Relatively large numbers of reporting endoscopists, ranging from 37% to 89%, have expressed experiencing musculoskeletal complaints most commonly affecting the left thumb, right wrist, neck, and back [27]. It has been shown that performing NOTES is signifi cantly more challenging for surgeons than laparos­copy [28]. The greater amount of muscular exertion required is linked to higher ergonomic risks. Monitor position is an important ergonomic factor during NOTES and other mini­mally invasive surgeries [29]. Functional laparoscopic studies point out that laparoscopic tasks are performed signifi cantly quicker and more precisely when the monitor is placed in the proximity of the surgeon ’s hands, in line with the sur­geon’s forearm –instrument motor axis [29]. Studies on eye­strain recommend avoidance of elevated monitor positions
above eye level. A downward viewing direction of 15 ° is the most neutral viewing direction for the extraocular muscu­lature. The distance to the monitor should be 80 –120 cm for avoidance of excessive accommodation, convergence, and staring [30]. This distance is based on a regular 19 -in. laparo­scopic monitor and is dependent on the screen size and image resolution. With 21 -in. high -defi nition monitors, a viewing distance of 80 cm may be considered too close [29].
Future thoughts
It is possible that NOTES in the future will not have to be performed in an operating room but could be done any­where. Laparoscopy can be performed safely in an endos­copy unit, as demonstrated by Hoffman et al. in over one thousand patients [18]. Second, NOTES has been performed at the bedside for “rescue” of a dislodged gastrostomy tube [17]. In this case report, a high -risked patient had a dis­lodged PEG tube in the early postoperative period with evi­dence of incomplete gastrocutaneous tract formation and intra-abdominal leakage. Transgastric NOTES was performed at the bedside with peritoneal exploration, evacuation of intra-abdominal fl uid, and re -establishment of the PEG tube through the original gastrotomy tract. This leads to the notion that NOTES with the right tools and accessories could be portable for appropriate indications.
Conclusion
NOTES has gained a great deal of attention from gastroen­terologists and surgeons all over the world since its introduc­tion in 2000 [5]. Breaching the gastrointestinal boundary opened the realm for new endoscopic techniques, innova­tive endoscopic instruments, and pioneering treatment modalities. For the widespread use of NOTES and for NOTES to be the real next frontier in endoscopy, endoscopists have to gain the ability to perform this minimally invasive tech­nique in their usual working environment, the endoscopy suite. The dedicated NOTES room design is an essential requirement for effi cient, safe, and state -of-the-art perform­ance of NOTES procedures. Provisions should be made for conversion to laparoscopic or open surgery. The proposed “high-tech” design decreases clutter, eases personnel move­ment, maintains sterile fi eld, improves ergonomics, and allows the use of fl uoroscopy and laparoscopic equipment when needed.
Disclosures
Mouen Khashab is a consultant for Boston Scientifi c.
Anthony Kalloo is a founding member, equity holder, and
consultant for Apollo Endosurgery.
254