Hybrid NOTES: A primarily NOTES procedure assisted by addition of a secondary modality such as laparoscopy
NOSE: Natural orifice specimen extraction. The use of a natural orifice through which to extract a surgical specimen
NOTES: Natural orifice translumenal endoscopic surgery
Pure NOTES: Surgical procedure completed wholly via a natural orifice without assistance provided through skin incisions
taTME: Transanal total mesorectal excision. Total mesorectal excision performed via a combined abdominal (open or laparoscopic) and transanal endoscopic approach
Viscotomy: A full-thickness surgical opening through a hollow viscous into the peritoneal (retroperitoneal, thoracic, mediastinal) space used to perform a diagnostic or therapeutic procedure in the peritoneal (retroperitoneal, thoracic, mediastinal) space
Following a few years of initial excitement and hype of NOTES, a more critical phase of grounded scientific investigation ensued. Benchtop and clinical research confirmed the safety and feasibility of a few focused procedures and dispelled some early NOTES concerns, particularly in regard to the risk of peritoneal contamination, safe viscotomy creation and closure, and the technical steps. Hence, clinical efforts in NOTES have become increasingly focused on a few targeted applications based on the route of access, each in varying stages of development and clinical application. The most common transvaginal procedures are cholecystectomy, appendectomy, and hybrid laparoscopic colon resections with transvaginal specimen extraction [3, 4]. Per-oral and transgastric procedures have focused on per-oral endoscopic myotomy (POEM) for the treatment of achalasia and transgastric resection of small gastric tumors. The least common NOTES access route, transanal, has (to date) been limited mostly to laparoscopic rectosigmoid resections with transanal specimen extraction (NOSE) and hybrid transanal-laparoscopic rectosigmoid resection for benign and malignant diseases. The most mature of these procedures is a hybrid transanal and laparoscopic total mesorectal (taTME) excision for the treatment of rectal cancer.
GI NOTES
During GI NOTES surgery, the natural orifice can be utilized in three different ways. First, the orifice is utilized as a site of specimen extraction following a standard laparoscopic resection. This technique is called natural orifice specimen extraction (NOSE). An example would be a laparoscopic sigmoid colectomy with transanal specimen extraction instead of extracting the specimen through an abdominal wall extraction site. A second method is utilizing the natural orifice as a route of access to the peritoneal cavity in order to perform a diagnostic or therapeutic operation on a separate body part. An example of this is a transvaginal cholecystectomy. The third method involves natural orifice access to perform an operation on the access organ. Examples of this include a transgastric tumor resection or transanal total mesorectal excision. As current clinical applications in the transanal NOTES realm do not yet include transanal access for operations on non-colorectal organs, this chapter will focus on NOSE and taTME.
Natural Orifice Specimen Extraction (NOSE)
Laparoscopic rectosigmoid resection has become the preferred treatment for rectosigmoid cancer and diverticulitis. The key steps of the procedure—complete left colon and splenic flexure mobilization, mesenteric vascular ligation, and intracorporeal anastomosis—can be safely completed exclusively through 5 and 10 mm trocars. Removal of the intact specimen, however, requires creation of a 5–10 cm abdominal wall incision. Several surgeons, in an effort to realize the greatest benefits of minimally invasive surgery, omitted this large abdominal extraction incision by using the open rectum through which to remove the colonic specimen (Video 23.1). This technique has come to be termed natural orifice specimen extraction (NOSE). Both transanal and transvaginal specimen (Videos 23.2 and 23.3) extraction have been described [5], but this section will focus on transanal specimen extraction following laparoscopic rectosigmoid resection. Interest in NOSE has significantly increased over the past 10 years.
Franklin was the first to report a large case series of NOSE during laparoscopic rectal and sigmoid resections dating back to 1991. He described delivering “the resected specimen out of the peritoneal cavity through an anatomic passage rather than through an abdominal incision” [6, 7]. This technique has subsequently been utilized and modified by others [8, 9]. The key steps of the technique are listed in Table 23.2. A standardized laparoscopic low anterior resection and mobilization is completed utilizing a total mesorectal excision technique. Intraoperative colonoscopy or proctoscopy is performed to confirm location of the pathology. Prior to rectal division, the rectum is copiously cleansed with 5 % Betadine solution irrigation. The bowel is divided intracorporeally either sharply or with endoscopic linear stapling devices, ensuring adequate oncologic margins. The specimen is then placed in a retrieval bag and passed to a ring forceps placed through the gently dilated anus. The specimen is extracted through the open rectum. The anvil of the circular stapler is then passed into the abdomen transrectally and secured in the proximal bowel. The upper rectum is then closed with a laparoscopic linear stapling device. End-to-end or side-to-end colorectal anastomosis is fashioned using a transanally delivered circular stapler. Finally, confirmatory air leak test is then performed.
Table 23.2
Steps of a laparoscopic sigmoid colectomy with natural orifice specimen extraction (NOSE)
1. Laparoscopic mobilization of the left/sigmoid/rectum |
2. Confirm location of the pathology (i.e., intraoperative endoscopy) |
3. Rectal washout with 5 % povidone-iodine solution |
4. Resection completed with intracorporeal division (i.e., energy, scissors) |
5. Bag the specimen |
6. Transanal specimen extraction (following gentle dilation of the anus) |
7. End-to-end anastomosis |
8. Leak test |
Franklin has reported remarkably good results in 277 patients undergoing transanal specimen removal [7]. The anastomotic leak rate was 1.1 %, with a major complication rate of 3.6 %. Hospital length of stay, however, remained comparable to standard specimen extraction at 6.9 days. Some complaints of minor fecal soiling were reported, but significant fecal incontinence has only occurred in three patients (1 %) [6]. They also do not report on what their specimen size cutoff was, as attempting to remove a large specimen transanally might damage the rectum or sphincter. Other groups have limited transanal specimen size to 4–5 cm, and larger specimens would then be delivered via an abdominal extraction incision.
Yet, in order to successfully utilize this approach, morbidity (including infectious complications and anastomotic leak) must be kept to a minimum. A prospective study of peritoneal fluid contamination following laparoscopic left-sided resections with and without NOSE demonstrated positive peritoneal cultures in 100 % and 89 % of patients, respectively. Only one of 17 patients in the NOSE group developed an anastomotic leak, and there was no difference in infectious complications between the two groups [10].
Despite the success in using natural orifice specimen extraction at these selected institutions, this technique has not yet caught on in most centers due to the additional time and technical skills required to perform these increasingly complex operations. In addition, there are ongoing concerns regarding potential damage to the rectum and sphincter complex, as well as fecal contamination of the peritoneum. As with the other complex laparoscopic procedures, more surgeons will likely adopt this technique over time as clinical experience and confidence increase.
NOTES Transanal Rectosigmoid Resection, Transanal TME (taTME)
Development of NOTES Transanal Rectosigmoid Resection
Early NOTES procedures that made headlines involved operations performed transorally or transvaginally. Further development of transoral procedures, however, has been markedly hindered because of their exclusive reliance on flexible instrumentation. To date, flexible endoscopic platforms fail to provide consistent and reliable traction and countertraction, visibility, hemostasis, and viscotomy closure capabilities compared to the laparoscopic corollary. In addition, the small diameter of the esophagus and pharynx limits specimen extraction size. Transvaginal access therefore became the most common NOTES access site as it overcomes much of these limitations. Using this platform, flexible instruments are replaced by the more familiar long laparoscopic instruments. Entry and closure of the viscotomy (i.e., colpotomy) is relatively simple and safe, and the vagina permits large specimen extraction with a low risk of complications.
Transanal NOTES was initially eschewed by many because of the obvious concerns over fecal contamination of the peritoneal cavity and the risk of a leak at the viscotomy site. These real concerns aside, the key components of NOTES are conceptually grounded in the training and practice of colorectal surgery. Colorectal surgeons regularly operate through the natural orifice (i.e., the anus) and are trained in the recognition and management of associated complications. Most colorectal surgeons are also adept at both advanced therapeutic endoscopy and advanced laparoscopic surgery. Lastly, intraperitoneal entry and closure via the anus occurs not infrequently during already established colorectal procedures such as an Altemeier perineal rectosigmoidectomy for rectal prolapse [11] and transanal endoscopic surgery [12]. Anatomically, the rectum and anus share the potential benefits of vaginal access, including a viscotomy site located close to the natural orifice (15 cm or less) and a compliant organ that allows for insertion of larger surgical instruments and permit extraction of large specimens. This collection of key skills and clinical experience provide the foundation from which the development of transanal NOTES surgery has occurred.
It is well known that total mesorectal excision (TME) remains the gold standard for rectal cancer surgery. The principle behind a proper TME is sharp dissection, under direct vision, in the embryonic fusion planes between the mesorectum and the surrounding parietal tissues continued down to the pelvic floor [13]. The TME plane of dissection also affords identification and avoidance of the parasympathetic and sympathetic nerves innervating the urogenital regions. Despite its wide acceptance, TME does have its technical challenges related to exposure and dissection of the proper planes in the confines of the deep bony pelvis. The pelvic curvature makes visualization of the anterior structures difficult, particularly in the obese or in males with an enlarged prostate. Long lighted retractors and/or headlights are required to gain visualization in the deep pelvis. Identification of the distal oncologic margin is estimated by techniques of external palpation, digital rectal examination, or visualization of a diffused tattoo—and this critical step is relegated to the end of the procedure. Even following successful pelvic dissection, current laparoscopic stapling devices utilized for rectal division have limited angulations, making a perpendicular rectal division and seal with a single cartridge application the exception rather than the rule. Hence, distal rectal division often necessitates several overlapping staple lines to complete the distal rectal transection, which may lead to increased risk of anastomotic leak [14, 15].
While NOTES surgery is being performed in very select cases in specialized centers, in reality, it is proceeding through three overlapping phases of clinical development. The first (and still ongoing) phase involves preclinical work identifying safety and efficacy, appropriate procedures, technical factors, and instrument development. A second phase will be early adoption of hybridized procedures that are a combination of established laparoscopic and transanal procedures. This phase is also starting to gain traction, though still remains somewhat of a niche. With increasing experience and new instrument development, the laparoscopic components can be phased out, and the third phase of fully transanal NOTES procedures will transcend.
Phase 1: Preclinical NOTES Developments
Based on the tenets laid fourth by the NOTES White Paper [2] calling for preclinical laboratory investigations prior to clinical introduction, several investigators began laying the groundwork for transanal NOTES procedures. Radical transanal sigmoid colectomy with intracorporeal anastomosis was initially performed in the cadaver model using off the shelf transanal endoscopic surgery instrumentation, demonstrating the feasibility and fundamental steps of this procedure [16]. This and other studies confirmed the reproducibility of this technique for pelvic rectal dissection [17–19]. From these experiences, it seems that the primary technical limitation of a pure NOTES rectosigmoid resection was not the pelvic dissection, but rather the sacral curvature and sacral promontory that limited current rigid and flexible instruments access and safe dissection higher in the abdomen. Key portions of the rectosigmoid resection such as high ligation of the inferior mesenteric artery and vein and left colon and splenic flexure mobilization could not reliably be accomplished with either currently available rigid or flexible instruments [17, 19, 20]. To overcome these obstacles, a hybrid transanal proctectomy with laparoscopic assistance for the abdominal portions of the procedure was the initial transanal NOTES procedure to break into the human clinical realm.