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SECTION 2 Current Clinical Applications and Techniques

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The ﬁ rst hybrid NOTES colon resection was reported by Lacy et al. [58], who performed a successful transvaginal mini-laparoscopic-assisted natural oriﬁ ce sigmoidectomy (MA-NOS) in a 78 -year -old woman with a T3N1 sigmoid adenocarcinoma. A trocar inserted transvaginally was used to perform dissection and stapling of both the inferior mesenteric vessels and the upper rectum. The colonic resection was performed extracorporeally, followed by an intra abdominal stapled anastomosis.

Next, Lamade et al. [59] reported a series of ﬁ ve patients operated by a combined trilumenal hybrid natural oriﬁ ces approach for sigmoid and colonic resection (Tri -PortNOS-SIG), using commercially available rigid laparoscopic instruments through the umbilicus, the vagina, and the rectum, without a signiﬁ cant abdominal incision. The specimen was retrieved through the anus and the postoperative course was uneventful for all patients, with a short length of stay.

Our red line from bench to bed in NOTES colonic resections

During colorectal procedures there are two critical steps that pose challenges for minimally invasive approaches. The ﬁ rst is the construction of the anastomosis and the second is the extraction of the specimen.

Solutions to obviate the need to enlarge a port incision or to perform a mini -laparotomy are the intracorporeal anastomosis and the use of the natural oriﬁ ces (anus or vagina) to help the dissection and to extract the surgical specimen.

NOTES approaches, however, add a new challenge of safe viscerotomy closure.

We have taken a stepwise experimental and clinical approach to developing minimally invasive techniques to address these challenges in sigmoid colectomy.

First, we performed a single port (Sugiquest Air Seal) sigmoidectomy on a survival porcine model to assess the feasibility of this approach [60] (Video 13.1).

Second, we performed the ﬁ rst totally NOTES sigmoidectomy using a combination of transgastric and transrectal access in a survival swine model involving ﬁ ve pigs (Video

13.2).

To achieve a good exposure and tension over the mesentery and to control the anvil of the circular stapler, we introduced the use of a transanal endolumenal magnetic manipulator [61] (Figure 13.1).

Next, we published the ﬁ rst human case of LESS sigmoidectomy for diverticulitis [62] (Video 13.3).

Furthermore, as a preparatory step toward NOTES colorectal procedures, we conceived a technique to achieve a percutaneous endolumenal control of the position of the anvil in virtually all the segments of the colon (PECAC) [45] (Video 13.4 and Figure 13.2).

We used this technique to perform a single -port sigmoidectomy with transabdominal specimen extraction and a tri port sigmoidectomy with transanal specimen extraction. A logical next step toward pure colorectal NOTES was to perform a full -laparoscopic single -port sigmoidectomy with transanal NOSE [63] (Video 13.5 and Figure 13.3).

LESS with transanal NOSE sigmoidectomy is clearly not suitable for all cases, thus careful patient selection is mandatory. Obesity, American Society of Anaesthesiology (ASA) score of 3 or 4, and surgeons ’ experience have been recognized as independent risk factors for conversion from laparoscopic to open surgery in a large patient series [64]. Furthermore, while in acute non -complicated diverticulitis inﬂ ammation tends to remain more localized, a past episode of acute sigmoiditis results more commonly in a thickened bowel wall and mesentery with signiﬁ cant adhesions. With no prior abdominal surgery, a low BMI, and mild, localized acute sigmoid diverticulitis, our patient was an ideal candidate for the procedure.

Finally, to provide a safe and reliable means of closing the transrectal viscerotomy, we proposed a novel technique using the circular EEA ™ hemorrhoid and prolapse stapler set with DST ™ technology developed by Covidien [65]. The advantage of the EEA ™ hemorrhoid stapler is in the long shaft of the anvil, which allows easy placement at the level of the rectal defect. The defect can then be invaginated around the anvil under visual control before connecting the stapling device.

To assess this circular stapled closure technique, we performed a prospective randomized trial on a porcine model with survival using the TEO surgical platform to perform a hybrid NOTES partial colectomy. We compared the efﬁ cacy of the transrectal viscerotomy closure by manual suture with the TEO instruments versus the circular stapled technique. Results showed that transrectal viscerotomy closure with EEA™ hemorrhoid stapler is signiﬁ cantly faster than suture closure through a TEO ™ platform with a histologic tendency toward less inﬂ ammatory reaction (Diana M., Endoscopy, submitted).

This rectal closure technique is another step in an ongoing effort to perform transrectal NOTES or hybrid NOTES colonic segmental resections for polyps or early cancers in all segments of the colon, overcoming the limitations of existing TEO ™ techniques. Combining secure rectal closure, our PECAC technique to control the position of the anvil, and a ﬂ exible long circular stapler will enable segmental resections everywhere in the colon (Video 13.6 and Figure 13.4).

Additionally, we assessed the feasibility of a transgastric or transvaginal NOTES sentinel node biopsy as an adjunct to endoscopic submucosal dissection of colorectal early stage neoplasia [66]. All the sentinel nodes were identiﬁ ed and underwent biopsy. Although not yet appropriate for human use, this proposal merits consideration as a potential

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IRCAD

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Figure 13.1 Totally NOTES sigmoidectomy by combined transgastric and transrectal access. (a) Cross -section view of the transgastric position of the gastroscope (Karl Storz, Tuttlingen, Germany). Exposure of the sigmoid colon is achieved with an endolumenal magnetic manipulator. (b) Mesenteric vessel dissection is achieved with endoscopic instruments inserted via the working channels of the endoscope. (c) The anvil of the circular stapler is introduced transanally and advanced above the proximal resection margin. (The shaded area indicates the intestinal segment intended for resection.) (d) A trocar is inserted transrectally and advanced intraperitoneally through the posterior wall of the distal sigmoid within

(g) (h)

IRCAD

the segment to be resected. Then a linear articulated stapler is introduced to transect the sigmoid at the proximal resection margin. (e) The divided sigmoid is exteriorized per ano via a “pull-through ” technique. (f) The sigmoid, including the colotomy, is then transected extracorporeally with a linear stapler. (g) The distal sigmoid is returned to its intracorporeal position. The strut of the anvil is snugged into a small enterotomy made close to the proximal staple line. The circular stapler is advanced within the rectosigmoid stump. (h) The anastomosis is then completed by ﬁ ring the stapler after mating of the anvil. © WebSurg / IRCAD

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Figure 13.2 Percutaneous endolumenal colonic anvil control. (a) After selection of the correct level for proximal bowel transection, the colon is punctured percutaneously under direct endoscopic and laparoscopic control with the PEG -Kit needle -cannula (Bard Access Systems, Salt Lake City, UT, USA). (b) The needle is withdrawn and the insertion wire is passed through the cannula into the lumen, where is grasped by an endoscopic forceps. (c) The wire is exteriorized per ano. The anvil of the

circular stapler (DST ™ series PCEEA Covidien) is tied to the wire. (d) The anvil is then pulled by traction on the wire back through the cannula and (e) snagged in the peritoneal cavity through the needle puncture site. (f) Once the anvil is correctly positioned in the bowel the linear stapler (EndoGIA™, Covidien) is ﬁ red across the colon below the anvil, either close by if an end -to-end anastomosis is planned (g) or at an appropriate distance if a side -to-side (h) anastomosis is intended. © WebSurg / IRCAD

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Figure 13.3 Transanal extraction of the sigmoid colon specimen. (a) Once the sigmoid colon segment to be resected is fully mobilized, a suture tie is placed at the distal resection site. (b) This allows washing of the distal colorectum and control of the proximal lumenal stream. (c) The rectum is opened below the level of the suture. (d) The sigmoid colon is delivered into the rectum and exteriorized per ano by pulling on the suture tie with a transanal inserted forceps. A colotomy is made within the exteriorized specimen and the anvil (with a suture ﬁ xed to its spike) is pushed cephalad into the descending colon and left above the level of

(k)

the intended proximal resection site. (e) Proximal transection is performed and (f) the rest of the specimen is delivered transanally. (g) The open rectal stump is then closed with a stapler and the remnant removed through an abdominal port. (h) A small enterotomy is made close to the staple line of the proximal colon and a hook is used to “ﬁ sh ” the suture attached to the anvil spike and entrapped in the staple line. (i) The anvil is then delivered into the enterotomy by pulling on the suture. (J) A standard mechanical anastomosis is then constructed. © WebSurg / IRCAD

SECTION 2 Current Clinical Applications and Techniques

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(a) (b)

Figure 13.4 Circular stapler viscerotomy closure. (a) A 2.0 Maxon ™ (Covidien, Mansﬁ eld, MA, USA) running suture is placed at the edges of the viscerotomy using TEO ™ (Karl Storz the anvil of the stapling device. (b) The EEA ™ hemorrhoid stapler is inserted through the TEO ™ device and the threads of the running suture are pulled downward to sit between the two parts of the stapler and then the latter is ﬁ red. © WebSurg / IRCAD

, Tuttlingen, Germany) and then tied using a pushing -knot to invaginate the mucosal edges of the rectal defect over

means of augmenting the effectiveness and appropriateness of minimally invasive endoscopic techniques for colon cancer.

We have further shown the feasibility of the MAGNAMOSIS™ magnetic ring anastomosis in both side -to-side and end-to-end colorectal anastomosis (unpublished data). The system has the ability to be delivered throughout the colon on an endoscope and precisely positioned using the PECAC technique. The system is currently under development, but showed reliable anastomosis with patency at 4 –7 days. A minimum force of 4 N is required for reliable anastomosis, thus thickness of the tissue and incorporating staple lines must be considered when using the device.

Chapter video clips

Video 13.1 Single-port sigmoidectomy on a survival porcine

model.

Video 13.2 Full NOTES sigmoidectomy by combined transgas-

tric and transrectal access.

Video 13.3 World premiere: single -port sigmoidectomy on a

human being.

Video 13.4 Percutaneous endoscopic colonic anvil control. Video 13.5 Laparo-endoscopic single -site (LESS) with natural

oriﬁ ce specimen extraction (NOSE) sigmoidectomy for diverticulitis.

Video 13.6 Novel technique to close transanal viscerotomy in

a full NOTES transgastric and transrectal partial colectomy.

Conclusion

Pure NOTES colonic resections are not yet a clinical reality. Hybrid NOTES has seen limited human use and will continue to grow with enabling techniques and technology.

In our opinion formed throughout a stepwise experimental approach, the best indication for NOTES in colorectal surgery is segmental colic resections for polyps not amenable to endoscopic mucosal resections or endoscopic submucosal dissection.

Accurate staging of the polyp would be mandatory for this indication and could be achieved by NOTES biopsy of the sentinel node.

The widespread adoption of colorectal NOTES will ultimately require techniques and technologies that are standardized to respect the core principles of colorectal surgery.

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CHAPTER 13 NOTES Applications in Colorectal Surgery

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NOTES Applied for Rectal Surgery

Patricia Sylla

Massachusetts General Hospital, Boston, MA, USA

Radical surgery for rectal cancer

The management of rectal cancer has evolved dramatically over the past 15 years. Improvements in surgical technique have led to the standardization of radical oncologic resections with signiﬁ cant impact on outcomes. Neoadjuvant therapy for locally advanced tumors not only decreases local recurrence rates following curative resection, but can also downstage tumors and increase the likelihood of sphincter preservation. While radical surgery for rectal cancer, including low anterior resection (LAR) and abdominoperineal resection (APR), offers the best long -term oncologic results for locally advanced tumors, it is associated with a 2 –8% mortality rate, 30% peri -operative complication rate [1], and a high incidence of functional disorders including urinary (5 –12%) [2] and sexual (10 –35%) [2,3] dysfunction, which are magniﬁ ed by the deleterious effects of pelvic irradiation. Given the cumulative morbidity of rectal cancer management, particularly in elderly patients, there has been signiﬁ cant interest in less -invasive surgical therapies.

Relative to open resections, laparoscopic colon surgery is associated with reduced length of hospital stay, faster recovery, and equivalent oncologic outcomes [4–7]. With respect to rectal cancer, multiple comparative studies have reported similar outcomes [8–10], and ongoing randomized controlled trials of laparoscopic versus open resection for rectal cancer will weigh in on long -term oncologic safety. Laparoscopic LAR, however, still requires sizeable abdominal incision for specimen extraction with comparable wound-related morbidity relative to traditional open resections, including wound infection rate, incisional pain, and hernia formation.

Local excision of rectal cancer

Transanal excision of rectal cancer is an attractive alternative to radical rectal resection in the management of premalignant rectal polyps and early cancers. Endoscopic polypectomy, and mucosal and submucosal resections, can be curative for adenomas to T1 cancers arising in pedunculated and even small sessile polyps. Inadequate resection margins or T1 rectal cancers inﬁ ltrating into the superﬁ cial submucosa or deeper require additional intervention to ensure complete resection and to rule out deeper invasion. Local excision consists in partial or full -thickness transanal resection of rectal lesions through the rectal wall, which permits accurate T staging and wider resection margins, with low associated morbidity. Transanal excision, however, can only be used for low rectal tumors, and mesorectal lymph nodes cannot be sampled with this approach, which results in potential understaging of rectal tumors. With respect to oncologic outcomes of early rectal cancers treated with transanal excision, the majority of series on transanal excision for low -risk T1 lesions report a 10 –15% rate of local recurrence [11,12]. Rates as high as 30% have been reported in association with high -risk histologic T1 features [13], including poor differentiation, lymphovascular invasion, and tumor inﬁ ltration deeper than the middle layer of the submucosa. These high -risk features are thought to correlate with a higher incidence of lymph node positivity, which ranges from ≤5% in low -risk T1 cancers to as high as 15% in high -risk lesions [14].

Among local excision techniques, Transanal Endoscopic Microsurgery (TEM) combines standard transanal access and endoscopy. TEM was introduced in 1983 by Dr Gerhard

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.

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Buess to resect mid - and high -rectal lesions not amenable to endoscopic removal or standard transanal excision. The TEM platform consists in a 4 cm wide multiport rigid platform equipped with CO

insufﬂ ation and a built -in optical

viewing system that permits precise and complete endolumenal endoscopic resection of rectal lesions using adapted surgical instruments. Using TEM, partial or full -thickness excision of rectal lesions located 5 –15cm from the anal verge can be achieved with signiﬁ cantly better optics than standard transanal excision. By virtue of providing better visualization and more precise dissection of rectal lesions, TEM was shown to result in lower rates of tumor fragmentation, margin positivity, and recurrence than standard transanal excision [15,16]. TEM is also associated with low complication rates, ranging from 8% to 26% [17–19]. While TEM is a compelling alternative to radical resection in the management of rectal adenomas and carcinoid tumors, it suffers from the same limitations as standard transanal excision with respect to oncologic adequacy in the management of rectal cancer. In several non -comparative case series that include low - and high -risk T1 rectal cancers, the overall local recurrence rate following TEM resection of T1 lesions ranged from 4% to 13% [17,20–23] and was substantially higher for T2 lesions [17,22]. The only randomized controlled trial comparing oncologic outcomes following TEM versus low anterior resection in 50 low -risk T1 rectal cancers reported no signiﬁ cant difference in local recurrence (4.2%) or 5 -year survival (96%) [23]. Based on the current literature on the use of TEM for rectal cancer without the use of neoadjuvant treatment, TEM resection is considered acceptable for low risk T1 rectal cancer with a local recurrence rate of 10% or less, compared to 6% or less following radical surgery with TME [24]. Based on these data, there is little controversy that the standard of care for high -risk T1 rectal cancers and more advanced tumors is curative radical resection, especially given the fact that salvage surgery in the setting of local recurrence following local excision can only be achieved in approximately 50% of patients [25].

Several clinical trials are currently under way to evaluate whether oncologic outcomes following local excision of high-risk T1, T2, and even T3 rectal cancers can be improved with the use of chemoradiation (CRT), in order to avoid the morbidity of radical resections. This is based on the observation that pre -operative CRT results in downstaging in 40 – 60% [26] or complete pathologic regression in 20 –30% [27] of locally advanced rectal tumors. A recent randomized controlled trial comparing outcomes following TEM versus laparoscopic LAR with total mesorectal excision (TME) for low T2 rectal cancers treated with neoadjuvant therapy reported similarly low ( ≤6%) local recurrence rates in both groups [28]. Based on these promising results, the American College of Surgeons Oncology Group (ACOSOG) phase II trial Z6041, GRECCAR II, and several other ongoing European trials are evaluating outcomes following local excision

using TEM of pre -operatively staged T2N0 rectal cancer treated with pre -operative CRT. Obvious concerns with this approach include the risk of over -treating node -negative T1 rectal cancers and under -treating node -positive T1 and T2 rectal cancers, with the incidence of local recurrence potentially delayed by more than 5 years as a result of neoadjuvant treatment. These limitations are in large part related to the fact that lymph node sampling cannot be achieved by currently available local therapies, and that pre -operative lymph node staging by endorectal ultrasound and pelvic MRI only has an accuracy of 60 –80% [29].

Beyond laparoscopy: NOTES

Since the report of the ﬁ rst human transgastric endoscopic appendectomy in 2004, natural oriﬁ ce translumenal endoscopic surgery (NOTES), or surgery performed using endoscopes inserted through natural oriﬁ ces rather than abdominal incisions, has been held as the next step in the evolution of minimally invasive surgery. Given the right tools, a wide range of surgical procedures could theoretically be performed endoscopically without the need for abdominal incisions [30]. Proposed advantages include the avoidance of wound -related complications, including incisional pain, infection, and herniation. Among potential NOTES access sites, transvaginal access has become the favored route with the international experience now counting thousands of pure and hybrid laparoscopic -assisted transvaginal NOTES cholecystectomy, nephrectomy, and sleeve gastrectomy [30–33]. Transvaginal endoscopic access and closure have the advantage of being relatively safe and easily reproducible with low risk of adjacent organ injury and of inadequate closure. Wide application of this approach is limited by the fact that it has not been widely endorsed by the surgical community, and that it has been met with varying degrees of enthusiasm by the public based on differences in cultural acceptance of transvaginal access [34,35].

Despite the fact that the transrectal NOTES endoscopic approach to the abdominal cavity shares the same ergonomic advantage as transvaginal access in terms of visualization of abdominal organs in line with the endoscope, until recently, transrectal NOTES was the least popular access route to the peritoneal cavity as reﬂ ected by the relative paucity of published experimental data and clinical reports relative to transgastric and transvaginal NOTES. This was due to the reluctance to create a colotomy and risk fecal contamination for procedures that would normally be associated with minimal risk of infectious complications. Preliminary feasibility studies and survival series on transcolonic and transrectal NOTES peritoneoscopy ( N = 35) [36–41], cholecystectomy ( N = 5) [42], ventral hernia repair ( N = 3) [43], rectosigmoid resection ( N = 10) [44], combined trans- gastric and transrectal/transcolonic access ( N = 15) [44,45],

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CHAPTER 14 NOTES Applied for Rectal Surgery

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hybrid transcolonic small bowel resection ( N = 4) [46], and combined transcolonic and transvaginal distal pancreatectomy ( N = 2) [47] in swine have cumulatively demonstrated the safety of this approach, with peritonitis and death occurring in only 1/74 survival animals (1.35%) due to incomplete closure of an anterior colotomy in a single animal [42]. These reports highlighted the importance of a stable endoscopic multitasking platform, such as TEM [41,44] and ISSA [36], to allow reliable transanal peritoneal entry into the peritoneal cavity, adequate endoscopic visualization, effective manipulation of abdominal structures, and safe closure of the site of entry.

With regard to the risk of fecal contamination during transrectal and transcolonic NOTES procedures, over two decades of published clinical results using TEM for rectal lesions and cancer have demonstrated that inadvertent entry into the peritoneal cavity during full -thickness excision of high-rectal lesions located above the peritoneal reﬂ ection is not associated with increase in infectious complications, precluded adequate closure of the defect can be achieved [48,49]. A recent report by Leroy et al. of 16 patients in whom peritoneal cultures were collected at the time of laparoscopic sigmoid colectomy with transanal specimen extraction for sigmoid diverticulitis, reported no infectious complications, although peritoneal cultures were positive for polybacterial growth in all 16 patients [50]. These data suggest that the risks of infectious complications with transrectal NOTES are likely to be similar to that of standard colorectal resections, depending on the degree of fecal contamination and the adequacy of the colotomy closure.

Transanal colorectal surgery

Preliminary experience with transrectal NOTES highlighted the fact that among all potential applications, transrectal and transcolonic access may be ideally suited for colorectal resection. The most compelling argument is that creation of a proctotomy is a routine step in colorectal procedures, rather than an iatrogenic event during other types of procedures such as a NOTES transrectal cholecystectomy. In addition, the proctotomy created is ultimately incorporated into a handsewn or stapled colorectal anastomosis, which reduces the infectious risks of a NOTES approach to that of a standard colorectal resection. Second, the concept of transanal colorectal resections is not entirely novel or provocative. Transanal rectosigmoid resection and transanal intersphincteric resection (ISR) are well -described procedures used in the management of rectal prolapse and of low rectal cancer, respectively. Perineal proctosigmoidectomy is a standard approach to treat full -thickness rectal prolapse, and an attractive and substantially less morbid alternative to abdominal procedures in elderly patients with extensive comorbidities [51]. For low rectal cancers located within the anal canal

(1–4 cm from the anal verge) that would traditionally require APR, sphincter -preserving transanal ISR in combination with TME is associated with good long -term oncologic outcomes. ISR involves open or laparoscopic rectal dissection with TME followed by transanal dissection of the internal sphincter (either in part or completely) in continuity with the rectum, off the external sphincter, which is preserved. The specimen is then exteriorized through the anus, transected, and standard colonic pouch -anal-handsewn or stapled anastomosis is performed with a diverting stoma. This approach increases the chance of achieving a negative distal resection margin with preservation of continence and good long -term oncologic [52–55] as well as functional [56,57] outcomes.

NOTES builds on the concept of transanal rectal dissection and goes one step further by proposing to perform complete rectal, mesorectal, and rectosigmoid dissection entirely transanally using an endoscopic platform. Proof of concept for this approach was presented in 2007, when Whiteford et al. described a pure NOTES technique for transanal rectosigmoidectomy in three human cadavers [58] using the TEM platform. This was the ﬁ rst report of a radical sigmoid colectomy with en bloc lymphadenectomy achieved entirely transanally using standard laparoscopic and TEM instrumentation. Quoted advantages of this approach included the excellent visualization provided by the TEM system, the ability to achieve tissue retraction and manipulation using TEM instrumentation, and to replicate all essential steps of an oncologic rectal dissection using this approach. Technical limitations included difﬁ culties overcoming the acute angle at the sacral promontory with the rigid metal TEM platform and to reach deeper into the pelvis with standard TEM instrumentation, which in turn limited the extent of sigmoid colon that could be mobilized with this approach [58].

NOTES transanal rectosigmoid resection: animal studies

The feasibility and safety of NOTES transanal colorectal resection was evaluated in an animal model. In a ﬁ rst pilot study conducted in nine swine cadavers and non -survival animals, transanal endoscopic resection of the rectosigmoid could be performed using standard TEM and laparoscopic instrumentation. The procedures were performed without bowel injury or other complications, and a steep learning curve was observed [59]. The same procedure was performed by other groups, demonstrating the feasibility and reproducibility of this approach [60]. Technical difﬁ culties encountered with this approach included the inability to advance the TEM platform above the sacral promontory, hence limiting exposure and reach of the sigmoid and more proximal colon [59]. These limitations highlight the fact that swine is a suboptimal animal model for this procedure in

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