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18 TAMIS: Current Controversies andChallenges
177
Complete muscle paralysis, decompression of the pneumoperitoneum with a Veress needle, and higher insufation pressures can also help main­tain a stable pneumorectum in the face of perito­neal entry [8]. With increasing experience, the rate of conversion following peritoneal entry dur­ing TEM has steadily decreased to below 10% [16, 26, 27].
It is unclear whether TAMIS has an increased risk of peritoneal entry as compared to TEM.Two recent case-matched studies comparing TEM/ TEO and TAMIS did not nd any difference in the rate of peritoneal entry between the two methods [10, 28]. The larger of these studies compared 181 TAMIS resections to 247 matched TEM resections and found similar rates of perito­neal entry (3% versus 3%, p= 0.97) for lesions with a median tumor distance of 7.0cm from the anal verge in both groups [10]. However, other studies have indicated that TAMIS is associated with a higher risk of peritoneal entry. Molina etal. examined this issue in 78 transanal resec-
tions using both TEO/TEM and TAMIS plat­forms [29]. They found that peritoneal entry occurred in 22 cases (28%) and the use of a TAMIS platform was associated with a higher risk of peritoneal entry. Furthermore, of four cases where peritoneal entry occurred during TAMIS, all four required conversion to a rigid platform to adequately expose and suture the defect. Overall, the risk of peritoneal entry during TAMIS appears to increase with distance from the anal verge, as does the risk of conversion to an alternative transanal or transabdominal approach (Table18.1).
When it does occur, peritoneal entry during TAMIS has been identied as a particular chal­lenge [29]. In a training model comparing TEM and TAMIS, surgeons consistently found TEM to be superior for dissection, quality of vision, and suturing difculty and found that TAMIS was not effective for suture of the simulated rectal lesion [30]. However, others have argued that this exvivo study did not account for either the variety
Table 18.1 Summarization of recent, larger TAMIS series and rates of peritoneal entry, as well as the need for conver­sion to an alternative surgical approach
Median distance from anal verge
Series N Platform Albert etal. [8] 50 Gelpoint path 8.1 1 (2%) Not converted Lee etal. [3] 25 SILS 9 0 N/A McLemore etal.
[11] Hahnloser etal. [2] 75 SILS 6.4 3 (4%) 3/3 (100%) converted to
Schiphorst etal. [12]
Gill etal. [59] 65 Gelpoint path 7.5 0 N/A Sumrien etal. [60] 28 Gelpoint path,
Haugvik etal. [61] 51 Gelpoint path,
Verseveld etal. [35] 24 SSL 8 Quaresima etal.
[62] Keller etal. [32] 75 Gelpoint path,
Caycedo­Marulanda etal. [13]
Total 545 22 (4%) 11/22 (50%)
a
Distance from the dentate line
34 Gelpoint path 4 3 (9%) 3/3 (100%) converted to
37 SILS, SSL 7
SILS
SILS
31 Gelpoint path,
SILS
SILS
50 Gelpoint path 7 5 (10%) No conversions
(cm)
a
NR 1 (4%) Not converted
8 0 N/A
a
9.5 5 (16%) 1/5 (20%) converted to
10 3 (4%) 3/3 (100%) converted to
Rate of peritoneal entry
1 (3%) 1/1 (100%) converted to
0 N/A
Rate of conversion following peritoneal entry
laparoscopic
laparoscopic or open
laparoscopic
transanal excision (TAE)
laparoscopy
178
H. Carmichael and P. Sylla
of TAMIS platforms available or the use of auto­mated suturing and knot-forming devices [31]. Worryingly, multiple TAMIS series have reported conversion to laparoscopy or laparotomy for an inability to close a rectal defect, detailed in Table18.1 [2, 11, 12, 32]. In contrast to TEM, the overall rate of conversion following peritoneal entry in TAMIS appears to be as high as 50% across larger series. It is unclear if this difculty is primarily reective of the long learning curve required for managing complex rectal lesions via TAMIS.In a large series of 50 TAMIS cases by Caycedo-Marundo etal., there were ve cases of peritoneal entry, and all defects were closed transanally via TAMIS [13]. The authors noted that for this to be feasible, the surgeon must have considerable experience suturing using TAMIS.
Thus, a reasonable approach may be to recog­nize that there may be increased risk of peritoneal entry with TAMIS as compared to TEO and TEM and that when TAMIS is used for lesions in the upper rectum, particularly larger and more ante­rior lesions, the surgeon should have experience and comfort with closing the defect using the TAMIS platform [23, 26]. If the surgeon does not have extensive experience with TAMIS, it may be worthwhile to consider prone positioning, avail­ability and experience with TEM equipment if difculty is encountered in closing via TAMIS, or discussing the risk of conversion to an abdomi­nal approach with the patient prior to surgery.

Oncologic Outcomes After Peritoneal Entry During TAMIS

Risk of peritoneal entry is similar or even increased with TAMIS as compared to TEM, as previously mentioned [28, 33]. Thus, peritoneal seeding is also a concern in TAMIS. However, the literature on long-term oncologic impacts of peritoneal entry during TEM for rectal cancer is sparse, and there is no published literature related specically to the concern of tumor seeding in the abdominal cavity with TAMIS.With regard to TEM, Morino etal. followed 13 patients where peritoneal perforation occurred during TEM per­formed for rectal adenocarcinoma [26]. Although
there were cases of local recurrence and lung metastases, no cases of liver or peritoneal metas­tases occurred with a median follow-up of 48 months. Similarly, Mege et al. followed 13 patients where peritoneal perforation occurred after TEM for adenocarcinoma, with no cases of local recurrence or distant metastasis after a median follow-up of 11.5 months [23]. Again, even with regard to TEM, long-term oncologic outcomes after peritoneal perforation are sparse.

Fecal Incontinence

There is an ongoing debate with regard to whether functional outcomes differ between TAMIS and TEM, particularly with regard to fecal inconti­nence. TAMIS has been hypothesized to be less likely to result in damage to the anal sphincter given the relative exibility of the disposable transanal ports as compared to the rigid TEM design [34]. Alternatively, outcomes could theo­retically be worse given the more extreme move­ments and stretch exerted on the sphincter in TAMIS. Although the literature on functional outcomes after TEM, both short and long term, is robust, there are few studies that have explored functional outcomes after TAMIS.
Short-term functional outcomes after TAMIS have been explored in two small prospective studies [12, 35]. Schiphorst etal. examined out­comes in 37 patients using the fecal incontinence severity index (FISI) and found that 88% of patients with abnormal baseline function experi­enced improvement in FISI scores, while 5% of patients overall experienced postoperative impaired continence [12]. Similarly, Verseveld etal. examined functional outcomes in 24 patients after TAMIS and found that 79% of patients with abnormal baseline FISI experienced improve­ment in continence after TAMIS, while 21% of patients overall experienced postoperative impaired continence [35]. These studies had a median follow-up of 11 and 6 months, respec­tively. These short-term results appear to be comparable to TEM, which has been shown to have rates of postoperative impaired continence ranging from 0% to 21% [3639].
18 TAMIS: Current Controversies andChallenges
179
However, a recent study by Clermonts et al. was the rst to examine long-term functional outcomes of TAMIS, with 42 patients and median follow-up of 36months [40]. The authors found that FISI score 1 year after TAMIS was similar to preoperative FISI (5.4 vs. 8.3,
p = 0.501), although worse at 3 years (10.1, p=0.01). In this study, 80% of patients with an
abnormal FISI prior to TAMIS exhibited improved FISI at 3 years; however, 63% of patients with normal continence at baseline experienced worsened incontinence at 3 years. This far exceeds the number of patients found to have impaired continence in studies with long­term follow-up after TEM [4143]. However, the authors noted that most of the functional impair­ment that developed after TAMIS was minor and perhaps with minimal impact on quality-of-life (QOL) measures. Indeed, a recent follow-up demonstrated that the worsened FISI scores did not affect broader QOL measures for these patients [44]. Given the current lack of head-to­head comparisons of TEM and TAMIS, it is unclear if one approach is superior in regard to functional outcomes.
Sleeve Resections forCircumferential Lesions
There are currently no published reports of the use of TAMIS for circumferential or “sleeve” resections. Arezzo etal. reported the use of TEO for resection of 17 circumferential rectal adeno­mas encompassing greater than three-quarters of the rectal wall circumference [45]. Lesions were at a median of 4 cm from the anal verge, with lesions’ longitudinal extent of 7cm. Sleeve resec­tion was performed, with circumferential full­thickness dissection of the distal margin, followed by tunneling through perirectal fat to the proxi­mal margin, and then circumferential incision of the rectal wall at the proximal margin. The anas­tomosis was performed transanally using a full­thickness running suture with 3–0 Maxon secured with silver clips (Richard Wolf, Knittlingen, Germany). All patients had negative margins. Two patients were upstaged to T2 rectal cancer
and underwent radical resection, with no recur­rence at 42 and 24 months follow-up, respec­tively. One patient who was upstaged to a T3 lesion and did not undergo resection due to comorbidities developed a local recurrence at 18months. One patient with high-grade dyspla­sia on nal pathology had a local recurrence that was salvaged with transanal excision, with no recurrence at 30 months. No other patients had local recurrence on follow-up.
The authors reported no incidence of fecal incontinence or sexual dysfunction. However, stenosis at the level of the anastomosis occurred in four patients. These patients were all treated with endoscopic balloon dilation. One patient developed a urinary stula after dilation that was managed conservatively. Similarly, Mege et al. documented 6 cases of rectal stenosis managed with endoscopic or surgical dilatation in a series of 194 patients undergoing resection with TEM, all of which occurred in large, circumferential adenomas (>50% of the rectal lumen) [23].
Although there are no published reports of the use of TAMIS for resection of circumferen­tial adenomas, it is reasonable to believe that this could be a feasible and effective option given the prior experience with the use of TEM for this purpose, provided the surgeon has expe­rience with suturing via a TAMIS platform. Furthermore, TAMIS platforms have been used for transanal total mesorectal excision (taTME), which required full-thickness and circumferen­tial rectal dissection, indicating the technical feasibility of performing the anastomosis trans­anally [46, 47]. The concerns about the high rate of stenosis observed in the previously described study of TEM for circumferential adenomas, however, would also be germane to the applica­tion of TAMIS for these lesions. The use of TEM or TAMIS to accomplish full-thickness excision of these lesions, as compared to par­tial-thickness excisions using endoscopic sub­mucosal dissection (ESD) or endoscopic mucosal resection (EMR), has the advantage of avoiding the need for further surgery if lesions are upstaged to early and low-risk rectal cancer, as is frequently the case for these bulkier lesions [48, 49].
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Partial- Versus Full-Thickness Resections andRisk ofStenosis
Overall, the risk of rectal stenosis with either TEM or TAMIS appears low, but it is much more common in patients undergoing TEM for circum­ferential lesions, with rates as high as 78% reported in the literature [50]. Some have argued that TAMIS should not be used for circumferen­tial adenomas because of this high risk of rectal stenosis [18]. Management of rectal stenosis after TAMIS or TEM is similar to stenosis seen after low anterior resection. Most cases described in the literature have been treated endoscopically with balloon dilatation or stenting, or as a proce­dure under general anesthesia using Hegar dila­tors. The stenosis usually improves with one to two treatment sessions [50].
It is unclear if partial-thickness resection in cases of larger, circumferential lesions is associ­ated with lower rates of stenosis when compared to full-thickness resection. Given concerns for higher rates of upstaging in such large adenomas, full-thickness resection may be preferable. For esophageal and gastric lesions involving more than three-quarters of the luminal circumference, endoscopic submucosal dissection (ESD) is asso­ciated with higher rates of stenosis as compared to endoscopic mucosal resection (EMR). However, these ndings may not be true for colorectal lesions, perhaps because the presence of stool in the rectum provides a dilating pressure as the scar heals. Ohara et al. found that only about 20% of ESD resections for these circum­ferential colorectal lesions developed stenosis at 1 month [51]. However, others have found that while asymptomatic stenosis may occur, symp­tomatic stenosis requiring intervention was rare, and the role of prophylactic endoscopic dilatation is unclear [52]. It is also unclear what role endo­luminal injection of steroids might play in pre­venting stenosis for colorectal lesions, although this has been used after ESD for esophageal and gastric lesions to prevent stenosis [53, 54].
Currently, there is no published evidence com­paring stenosis rates after full-thickness resection using TAMIS to those seen after partial-thickness resection using ESD or EMR.Although there is a
theoretical benet to full-thickness resection of large adenomas over partial-thickness resection given higher rates of occult malignancy in these lesions, it is unclear if this benet is outweighed by the risk of stenosis.

Economics

There are no formal cost analyses comparing TAMIS to TEM, although it is broadly accepted that TAMIS is less expensive. The upfront cost of the TEM platform is approximately $80,000, while the cost per disposable transanal port is approximately $500 to $800 [11]. Other authors have noted that the cost of the insufation tubing to TEM is equivalent to the cost per disposable port [20]. A matched analysis comparing TEM and TAMIS found that TAMIS had signicantly lower median operative time (70 min versus 108min, p<0.001) as well as lower median hos­pital length of stay (0 days versus 1 day, p<0.001) [10]. So while it appears that TAMIS is likely cost-effective relative to TEM, there are no published studies showing this.

Unusual Applications

Typical indications for transanal endoscopic sur­gery have been for removal of rectal adenomas not amenable to standard endoscopic resection, treatment of early rectal cancer, and scar excision following neoadjuvant therapy [55]. However, TEM has been used for a variety of rectal lesions including neuroendocrine tumors, gastrointesti­nal stromal tumors (GIST), presacral tumors, benign stricture, rectourethral stula, endorectal condylomas, rectal prolapse, pelvic abscess, and management of traumatic or iatrogenic rectal perforation [55]. TEM has also been used in the management of even more rare rectal lesions such as isolated rectal ulceration, rectal endome­triosis, ganglioneuroma, and melanoma [56].
Considering TAMIS specically, published applications have been more limited, but the use of TAMIS has been reported in the management of neuroendocrine tumors [8, 11, 57] as well as
18 TAMIS: Current Controversies andChallenges
181
GIST excision and pelvic abscess drainage [57]. TAMIS has also been used to correct stenosis occurring after low anterior resection as well as pouch-related issues after proctocolectomy for inammatory bowel disease [58]. Finally, tech­nology developed for use in TAMIS has now been used for transanal total mesorectal excision (taTME), which will be the topic of the remain­der of this book.

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Part II
Transanal Total Mesorectal
Excision (taTME)

Indications for Malignant Neoplasia of the Rectum

Reagan L. Robertson and Carl J. Brown
19
The surgical management of rectal cancer contin­ues to present surgeons with many challenges. Total mesorectal excision (TME) is the standard of care in rectal cancer surgery, with the goal of negative circumferential and distal resection mar­gins (CRM and DRM) and clearance of the asso­ciated lymph nodes. High-quality TME is associated with lower locoregional recurrence rates and improved patient outcomes [1]. Innovations in rectal cancer surgery have led to the introduction of laparoscopic and robotic tech­niques of TME dissection. Regardless of opera­tive approach, the traditional “top-down” TME retains several signicant challenges. Operating in the conned space of the pelvis is technically challenging due to several tumor- and patient­related factors, particularly for low lesions. High rates of conversion, positive margins, and subop­timal TME quality remain ongoing issues. Additionally, as transanal minimally invasive approaches to rectal neoplasms are increasingly used, radical resection following local excision is more common, which poses new technical chal­lenges related to perirectal inammation and brosis.
The “bottom-up” approach of taTME has
several advantages in overcoming the chal-
R. L. Robertson · C. J. Brown(*) St. Paul’s Hospital, Department of Colorectal Surgery, Vancouver, BC, Canada
lenges of abdominal TME.The novel transanal vantage point, in theory, could facilitate better margins and higher rates of success with mini­mally invasive procedures in patients with rec­tal cancer. Currently, long-term outcomes of the procedure are not known, and there are no stan­dardized methods for patient selection. The procedure should not be applied to all patients, and careful consideration of the potential risks and benets to the individual patient is required. This chapter reviews the various indications for taTME in malignant disease of the rectum and its proposed advantages for certain patient populations.

Operative Approach for TME

Abdominal TME
The gold standard for rectal cancer resection is high-quality TME, as described by Heald [1]. Conventionally, TME has been performed via an open abdominal approach in the “top-down” fash­ion. Laparoscopic and robotic TME have recently become more widely adopted in recent years. Whatever the approach, low pelvic dissection presents many well-described technical chal­lenges. The bony pelvis creates a rigid and narrow operative eld, and visualization is often subopti­mal. The use of long instruments leads to problems with conict and angulation. Delineation of the
© Springer Nature Switzerland AG 2019 S. Atallah (ed.), Transanal Minimally Invasive Surgery (TAMIS) and Transanal Total Mesorectal Excision (taTME), https://doi.org/10.1007/978-3-030-11572-2_19
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distal margin and rectal transection with stapling devices can be difcult and imprecise. These dif­culties become further exaggerated in the nar­row male pelvis or in obese patients with a bulky mesorectum [2, 3]. In laparoscopic surgery, the traction required to obtain adequate visualization may lead to mesorectal tearing and defects. Multiple laparoscopic stapler rings may also be required for distal transection, which may lead to more anastomotic complications [36]. These challenges may have negative effects on patients’ pathologic and oncologic outcomes. Correct plane of dissection is critical when performing TME. Wrong plane dissection can lead to poor quality TME (incomplete mesorectal envelope), which is associated with worse long-term onco­logic outcomes [1, 7]. Alternatively, dissecting outside the mesorectal plane can lead to injury to other critical structures such as the pelvic nerves, presacral and side-wall vasculature, or urogyne­cologic structures. Such injuries can have impor­tant deleterious effects on patient function and quality of life.
Laparoscopic TME (lapTME) has some short­term advantages over open TME, including shorter length of stay and return of bowel func­tion, less postoperative pain, and lower rates of wound infection [8]. Multiple studies have also shown that lapTME appears to be a safe alterna­tive to open TME for rectal cancer in terms of morbidity and oncologic outcomes [9, 10]. Regardless, lapTME continues to pose some sig­nicant challenges. A need for conversion to an open procedure has been reported in 10–34% of patients, particularly for males, the morbidly obese, and those with a narrow pelvis [9, 11, 12]. In the COLOR II trial, 16% of patients were con­verted to open; a narrow pelvis (22%), obesity (10%), and issues with visualization and tumor bulk were also cited as common reasons [9]. Robotic TME hoped to address some of the issues seen with lapTME, but conversion rates remain high in certain patients with predictors of dif­cult TME, such as obesity [13]. Converted proce­dures are known to have worse oncologic outcomes than both their open and laparoscopic counterparts [2]. These results raise concern regarding the use of lapTME, especially in these
patient populations. In addition, two recent stud­ies, the ALaCaRT and ACOSOG Z6051, failed to show non-inferiority of lapTME over open TME for rectal cancer when assessing margin status and TME quality [14, 15]. Traction injuries to the mesorectum sustained while attempting to gain exposure in the deep pelvis and difculty with accurate denition of the distal resection margin from above are thought to have contributed to the results. Abdominal TME has reported rates of positive CRM of 1.2–18.1% and incomplete or near-complete TME in 11–13% and 25–28% of patients, respectively [16]. These ndings high­light the ongoing challenges with performing TME dissection and the need for alternate opera­tive strategies that may improve outcomes.
Transanal TME
including lapTME, open and endoscopic trans­anal dissection, and natural orice surgery. It has become apparent that the “bottom-up” dissection addresses some of the problems inherent to abdominal TME.Precise delineation of the distal margin is easily accomplished with the transanal operating scope and placement of a distal purse string (Fig.19.1). Accurate denition of a clear
Fig. 19.1 Demonstration of delineation of the distal mar­gin with the purse-string suture during taTME.The rectal tumor is visible in the proximal rectal lumen with a clear distal margin between the lesion and the proximal purse­string suture