• Peritoneal access
• Gastric closure
• Prevention of infection
• Suturing and anastomotic devices
• Maintaining spatial orientation
• Development of a multitasking platform
• Management of intraperitoneal complications and hemorrhage
• Physiologic untoward events caused by NOTES
• Training
Since the first description of the procedure, more than 2,000 clinical NOTES have been reported. Transvaginal route has been the most common followed by transgastric approach, while cholecystectomy and appendectomy have been the most popular procedures reported. Meta-analyses and single-center studies of NOTES in humans have revealed that cholecystectomy, appendectomy, mediastinoscopy, and peritoneoscopy procedures for intestinal and renal cancers are all feasible [10–12].
Instrumentation
Access
Technical complications encountered during NOTES have revealed that there is a need for new endoscopic instruments, in order to safely perform these procedures.
Initially published papers led to believe that NOTES would be done primarily as transgastric procedures. However, peritoneal cavity could safely be accessed through a variety of other transluminal routes. Gynecologists had been accessing pelvic organs transvaginally since the early twentieth century. In fact, the first transvaginal cholecystectomy had been performed by Tsin et al. long before the White Paper by NOSCAR [12]. Currently most human NOTES procedures use transvaginal access since this route is well established and vaginal closure is safe, secure, and easy to perform. On the other hand, transgastric access still seems to be a better approach as it is more universally available than transvaginal and often more appealing to the patients. However, despite the availability of variety of closure devices and techniques, endo-luminal method of determining closure security at the end of a transgastric or transrectal procedure remains an unresolved issue.
Transvaginal NOTES access devices have been initially reported on by Gettman et al. [13]. In their technique following a posterior colpotomy, modified 24–30F dilators were inserted over a 24F dilating balloon as access ports. Further reports, including the first reported transvaginal cholecystectomy in the USA, either used standard laparoscopic ports (12 or 15 mm) or rigid ports with outer diameter between 21 and 26 mm as transvaginal access sites into the abdomen. Clayman et al. performed hybrid nephrectomy in a porcine model using the most novel system [14]. Furthermore, 12 mm laparoscopic ports were used for both transcolonic and transvesical access.
However, NOTES without any laparoscopic assistance have not been achieved yet. Limitations of technology for the access still need further development in instrumentations. Therefore, the ideal matchup between access, pathology, and patient preference has yet to be determined.
Operating Instruments
In addition to the access, there are still some other limitations in current NOTES instrumentation, including minimal traction-countertraction that is required. In order to overcome these limitations, multitasking endoscopic platforms and new instruments have been developed and used to achieve better triangulation with promising results. Magnetic anchoring and guidance system (MAGS) has been used widely to facilitate especially single-port NOTES-assisted nephrectomies [15]. Multitasking platforms such as TransPort® (USGI Medical San Clemente, CA), Cobra™ (USGI Medical, San Clemente, CA), R-scope (XGIF-2TQ160R; Olympus Corp, Tokyo, Japan), the Endo-SAMURAI™ (Olympus Corp, Tokyo, Japan), and the Direct Drive Endoscopic System (DDES) (Boston Scientific, Natick, MA) each have a common flexible endoscopic design with some differences on channel system, motion, angulations, and suturing being used [16–20].
Clinical Applications
Autorino et al. analyzed the published literature between 2006 and 2012 and found 644 publications [21]. More than half were original articles, around 30 % were review articles, and 12 % were case reports. Half of the articles were animal studies. Eighty percent of the papers originated from Europe and the USA only. When they divided the time period in two eras as early (2006–2008) and late (2009–2011), they found a significant increase in the number of clinical cases reported per article (2 vs. 6, p = 0.008) and a significant increase in the number of randomized controlled trials (RCTs, 5.6 % vs. 7.2 %) or non-randomized but comparative studies (5.6 % vs. 22.9 %, p < 0.001) from the early to the late period.
Table 32.2 shows the distribution of published articles, procedures, access route, and the technique used between early and late period.
Table 32.2
The distribution of published articles, procedures, access route, and the technique used between early and late period
Early (2006–2008) | Late (2009–2011) | |
---|---|---|
Publications n (%) Original article Case report Review, consensus | 138 (54.1) 36 (14.1) 81 (31.8) | 220 (56.6) 44 (11.3) 125 (32.1) |
Procedures n (%) Cholecystectomy Colorectal resection Gastric surgery Peritoneoscopy Nephrectomy Access (closure, creation) Others | 28 (18.1) 9 (5.8) 18 (11.6) 32 (20.6) 7 (4.5) 29 (18.7) 32 (20.6) | 49 (18.4) 32 (12.0) 34 (12.7) 21 (7.9) 19 (7.1) 38 (14.2) 74 (27.7) |
Access route n (%) Transgastric/transesophageal Transcolonic/transanal Transvaginal Transvesical >1 Access, or other access | 77 (53.8) 16 (11.2) 24 (16.8) 10 (7.0) 16 (11.2) | 133 (51.8) 33 (12.8) 18 (7.0) 40 (15.6) 33 (12.8) |
Technique n (%) NOTES Hybrid NOTES NOTES-assisted laparoscopy >1 Technique | 221 (90.6) 17 (7.0) 6 (2.5) 0 | 304 (81.3) 29 (7.8) 32 (8.6) 9 (2.4) |
A review paper by Keller and Delaney covering the period between 2004 and 2013 [11] found that with the abundance of safety and feasibility studies, only 43 reports covering 432 cases were reported in humans. Cholecystectomy (84 %) and appendectomy (7 %) were the most popular procedures reported. Therefore, they concluded that the question why NOTES has not progressed further into the clinical practice remains unanswered. However, one should take into consideration that the progress of NOTES is directly related to the developments in instrumentation, its worldwide availability, and of course acceptability by practitioners.
Hybrid NOTES is the combination of laparoscopic and endoscopic techniques which may allow operations beyond cholecystectomy. Therefore, currently, it is more common than novel NOTES in humans, comprising over 50 % of the reported cases. Hybrid approach is also thought to be safer enabling better visibility of the abdomen and standard suturing [22].
In their current review, Bingener et al. have evaluated all published reports on NOTES in emergency situations and concluded that although appendectomy is one of the most common NOTES procedure, the value of NOTES in patients with diverticulitis, ulcer perforation, and infected pancreatic necrosis is not clear yet [23]. They have found NOTES quite useful for gastrostomy tube insertion in the ICU and repair of iatrogenic perforations during colonoscopy as it might save the patients from unnecessary laparotomy.
Challenges
Technical
NOTES still has some unresolved issues identified and published by working group of NOSCAR, including access, closure, devices, spatial orientation, etc. as shown in Table 32.1.
Many different access routes to peritoneal cavity including transgastric, transvesical, transcolonic, transvaginal, and combined have been described. Main access routes in humans are transvaginal and followed by transgastric, transesophageal, and transrectal, respectively [24–26]. The transgastric approach requires creation and dilatation of a hole on the anterior stomach wall for the introduction of the operating platform. Therefore, there is a certain level of risk of bleeding, leak, or injuring the adjacent organs or tissues. In order to decrease the risk, some devices, such as endoscopic ultrasound, have been reported to be used but its efficacy needs to be evaluated in humans [27].