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17 Transanal Robotic Surgery andFuture Directions
167
mastery of single-port laparoscopy. Robotic TAMIS, or robotic transanal surgery (RTAS) is a natural evolution of the approach and promises to address the technical challenges of reach, visual­ization, retraction, and ergonomics that has lim­ited endoluminal surgery.
Current Applications andOutcomes
Atallah etal. demonstrated the feasibility of robotic TAMIS using the da Vinci Si robotic platform in a cadaveric model in 2011 and reported the rst human case with resection of an early stage rectal cancer in 2012 [15, 16]. Subsequently several authors have reported on the feasibility and safety of robotic TAMIS. The advantage of robotic sur­gery comes with its magnied 3D view, wristed movements, tremor elimination, and excellent ergo­nomics, which allow for greater precision. Initially used for local excision of rectal neoplasms, robotic TAMIS was soon adopted for more complex proce­dures, with the rst report of RTAS-TME (i.e., robotic taTME) in 2013 by Atallah etal. [17]
Robotic TAMIS using the da Vinci multi-arm robotic platforms works through a transanal dis­posable access channel, for example, the GelPOINT path transanal access platform [18]. Such access channels are required to create a seal that maintains the insufation within rectum needed for adequate visualization. The da Vinci Si robotic system, while demonstrated to be fea­sible for local excision of distal rectal tumors, is limited by its multiple bulky arms and restricted eld of view which prevent effective treatment of more proximal lesions. Hompes etal. in a series of 16 patients, where both malignant and benign rectal lesions were locally excised, used a trans­anal glove port which permitted wider movement of instruments within the rectum and reduced arm collision externally [19]. The next- generation Xi system addressed this partially with decreased arm bulk, in turn, allowing easier transanal dock­ing and more proximal operative reach. The major disadvantage with this platform is the lack of 5-mm instrumentation, a signicant issue in the small working space of the anus and rectum (currently, only 8mm instrumentation is avail­able with the Xi platform).
Despite the limitations of these multi-arm robotic platforms, Atallah etal. have successfully performed taTME and repair of complex stulae via robotic TAMIS [20]. They reported on four patients who underwent RTAS-TME for invasive adenocarcinoma of the distal rectum. All speci­mens were found to be complete or near com­plete mesorectal excisions with negative distal and circumferential margins. Similarly, in a pro­spective pilot study by Gomez etal. using the da Vinci Si, RTAS-TME was performed in ve patients, and all TME specimens showed com­plete mesorectal excision with negative distal and circumferential margins [21]. Robotic TAMIS for these applications has only been reported in small series, and long-term oncologic outcomes have yet to be studied.
Transanal surgery is highly demanding due to the conned anatomic space in the pelvis, restricted exposure, and limited proximal reach. The conventional multi-trocar robotic platforms were originally designed for transab­dominal access [22]. The effector arms of these systems are not exible, limiting dexterity in the narrow pelvis, and the 8mm instruments add bulk and subtract from eld view in this conned space [22]. Furthermore, the sacral angulation in the pelvis and instrument torque prevents dissection beyond 7–8 cm from the anal verge. The current platforms have limita­tions with control of operative eld, endolumi­nal suturing, and surgeon ergonomics– making it challenging even for those with extensive experience [23]. Most importantly, while workable, the Si and Xi da Vinci platforms used transanally represent a potential risk to the external sphincter complex and present ergo­nomic obstacles which cannot be overcome. Due to these factors, it is not likely that robotic transanal approach will be widely adopted without platform innovation.
New Platforms inRobotic TAMIS
Despite the demonstrated benets of minimally invasive surgery (MIS), the eld of colorectal surgery has been slow to adopt MIS techniques, especially for transanal procedures. The high
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technical difculty of TEM and TAMIS is the primary barrier to wide adoption. The effective­ness of an operative technique is determined by the level of difculty relative to other approaches. Thus, broadly speaking, a specic operative approach is highly effective if the majority of surgeons can perform the operation with high completion rates and good/excellent clinical outcome. If an operation is so difcult that few surgeons can perform it with good out­come, it is effective in the hands of a select few but has limited effectiveness in the wide world of surgical practice. Thus any technology which reduces the technical difculty in the execution of an operation will automatically increase its effectiveness and ultimately benet patient care. This aim motivates ongoing innovation in robotic transanal surgery.
An ideal platform for robotic TAMIS addresses four challenges of robotic TAMIS: (1) optimal visualization, (2) ergonomic instrument control, (3) improved proximal access, and (4) ease of tissue extraction and manipulation. To address these goals, a multitude of systems have been and are under development. The Flex® Robotic System, STRAS (Single-Access Transluminal Robotic Assistant for Surgeons) robot, and the da Vinci Single-Port (SP) Surgical System are all emerging robotic platforms designed to meet the challenges of transanal surgery.

Flex® Robotic System

The Flex® Robotic System together with the Flex® Colorectal (CR) Drive (MedRobotics, Corp. Raynham, MA, USA) is a semi-robotic apparatus specically indicated for transanal surgery. This single-port access platform with exible effector arms allows for instrument tri­angulation and purposeful steering of the instru­ment head along nonlinear circuitous pathways making it more suitable for NOTES, even for transluminal lesions proximal to the rectosig­moid junction (Fig.17.1a). The robotic console or Flex® cart, driven by the operating surgeon at the bedside, has a control knob that can be
manipulated to control the Flex® scope (Fig. 17.1b). The Flex® Base accommodates a disposable Flex® Scope CR drive, which is then docked transanally (Fig. 17.1c). The two main units of this system are operated by a single sur­geon, eliminating the need for a bedside assis­tant. Flexible, pistol-grip instruments are used to perform the surgery, through a bedrail-mounted apparatus, permitting triangulation (Fig.17.1d). This exible robotic system allows access to remote anatomic elds with an operative reach of 17 cm. In addition, smaller 3.5 mm instru­ments allow for minimal restriction of the eld of view [24].
Obias, Sylla, and Pigazzi presented their ini­tial experience of this system for transanal access in a preclinical setting during the proceedings of the American Society of Colon and Rectal Surgeons and Tripartite Meeting in Seattle, Washington, in 2017 [25]. Feasibility of this plat­form in performing targeted NOTES operations in a cadaveric model was reported by Atallah in 2018 [22].
Visualization with the Flex® Robotic System is improved compared to laparoscopic TAMIS in that it does not require an assistant and the operative eld of view can be set by the operat­ing surgeon. The primary advantage of the Flex® Robotic platform is that it allows trans­mission of the platform along circuitous path­ways for better access to more proximal lesions than would otherwise not be possible by con­ventional methods. Drawbacks of this platform are that the robotic camera and platform move­ments use separate modules and redening the operative eld of view is time consuming [22]. In addition, the exible arms are not robotically assisted, and thus this system is considered semi-robotic. This introduces the problem of tremor, and this can detract from the precision of an operation. The exible pistol-grip instru­ments also require a high level of laparoscopic technical skill, even more so than the straight instruments used in laparoscopic TAMIS.While this platform addresses some of the fundamental challenges of transanal surgery, it has signi­cant ergonomic shortcomings that are likely to limit its adoption.
17 Transanal Robotic Surgery andFuture Directions
169
Fig. 17.1 Flex® Robotic System. (a) Two 3.5-mm diam- eter exible effector arm interface. (b) Round control knob that serves as the master control for the Flex® Robotic Scope. (c). Flex® Robotic base accommodates
STRAS Robot (Single-Access Transluminal Robotic Assistant forSurgeons)
The STRAS is an ergonomic master–slave sys­tem, with an intuitive control interface allowing the surgeon to comfortably operate the system. Andras etal. reported the feasibility of this sys­tem in colonic endoscopic submucosal dissection in animal models in 2017 [26]. The slave unit consists of a carrier cart and a detachable exible endoscope, which is a 50cm exible device with two 4.2 mm working channels for instruments and one 2.8 mm working channel for conven­tional exible endoscopic instruments (Fig.17.2) [27]. The 50cm endoscope should allow access to lesions within the sigmoid colon. The motor­ized endoscope is initially inserted under endo-
the Flex® Robotic Colorectal Drive. (d). Simulation of a transanally docked Flex® Robot System with Colorectal Drive. (From Atallah [24])
Fig. 17.2 STRAS operating tip. Comprised of a 50cm exible device with two 4.2mm channels through which instruments are passed. The black arrow indicates the
2.8 mm working channel for conventional endoscopic tools, and the red arrow identies the two arms on the open side, which allow for the triangulation of robotic instruments. (From Légner etal. [27])
170
scopic visual control, and once it reaches the target, the endoluminal view is established as it is re-attached to the slave cart. Like the Flex® Robotic System, the STRAS robot requires sig­nicant time to redene the operative visual eld. The endoscope needs to be positioned into place manually, and the STRAS master console pro­vides limited control of the endoscope.
The robotic instruments consist of a proximal motor and a exible shaft with a bendable distal tip. The two opening arms at the tip of the endo­scope allow for endoluminal triangulation for
Fig. 17.3 The da Vinci SP system’s single 25-mm can­nula through which three 6 mm, multi-joined, wristed instruments and a 3D 0
the instruments. The master console provides continuous feedback regarding the actual posi­tion of the tools. With only two robotically con­trolled instruments, a notable limitation of this system is the lack of effective retraction. Additionally, this platform lacks suturing capa­bilities, thus limiting its use beyond partial thick­ness excisions.
As currently congured, both the Flex® Robotic System and the STRAS robot are opti­mized for partial thickness local excisions of the rectum. However, the current generation’s limita­tions hinder these platforms’ adoption to more complex operations such as taTME, stula repair,
Fig. 17.4 At-large view of the da Vinci SP platform’s set up intraoperatively
and pure NOTES proctocolectomy. Notwithstanding, these platforms improve ergo­nomics to a signicant degree compared to stan­dard, laparoscopic-based TAMIS.
(Fig.17.5) allows for manipulation of the opera­tive eld so that all quadrants of the rectum can be accessed without repositioning the patient. A holographic monitor of instrument position

Future Directions: da Vinci SP Surgical System

assists the surgeon to better understand intralu­minal instrument collisions; effectively, it serves
as a navigational aid to keep track of instrument The next-generation da Vinci robotic platform, which is pending FDA clearance for use in TAMIS procedures, is a single-arm, single-port system. The da Vinci SP system includes three 6mm, multi-jointed, wristed instruments and the rst da Vinci jointed 3D 0° HD camera.
position. This feature combines well with three-
arm control that assists in creating optimal instru-
mental retraction easily. The fully robotic wrist
with 6° of movement articulation allows for the
control that previous surgeons have become
accustomed to with the robot. Collectively, the three instruments and the cam­era head are transmitted through a single 25-mm cannula (Fig.17.3). This advanced platform with its unique “cobra camera” and exible end effec­tor arms allow for more proximal reach transa­nally (Fig.17.4). Signicant benets of this new technology are many. A rotating 360° platform
tarium of the transanal surgeon. Current limita-
tions include the absence of an RTAS suction
device, vessel sealer, and stapler. However, these
same challenges have been overcome with every
new generation of robot, so it can be reasonably
predicted the same will take place here. This
K. M. Izquierdo et al.
°
HD camera extend
RTAS approaches will expand the armamen-
17 Transanal Robotic Surgery andFuture Directions
171
Fig. 17.5 da Vinci SP Surgical System. (a) Three-arm control shown working in the rectum. (b) Local excision using three-dimensional retraction. (c) Transanal knot tying. (d) Full thickness transanal rectal closure
Fig. 17.6 The da Vinci SP Surgical System with Applied GelPOINT Path Transanal Access Platform
system has been studied in the preclinical setting by Marks et al. [23] The da Vinci SP Surgical System with Applied GelPOINT Path Transanal Access Platform (Fig.17.6) was used to perform transanal local excision in cadavers. Twelve sim­ulated lesions were excised with negative mar­gins and without fragmentation. In addition,
suture closure of the defect and endoluminal knot
tying were carried out with relative ease [23].
To date, the feasibility and safety of this ex­ible single-arm robot has been studied primarily for transoral applications. This system is yet to be validated in a clinical setting for transanal sur­gery in the United States; in Hong Kong, it is
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being used in early clinical trials for colorectal applications, including taTME. This exciting new technology in endoluminal access will likely expand its applications, stepping into the current era of NOTES.

Future Directions: Pure NOTES Colorectal Surgery

The concept of NOTES has gained popularity since the first transgastric appendectomy per­formed by Rao and Reddy in 2004. In con­cept, however, Dr. Buess’ TEM in 1983 was the first NOTES procedure. Now, nearly 40years later, technology has advanced to a point where this concept can be revisited by surgeons.
Avoiding altogether an abdominal incision and its associated risks, such as surgical site infections and incisional hernias, as well as pro­viding perfect cosmesis, RTAS represents a para­digm shift in MIS.The nal step on the path of transanal NOTES colorectal surgery would be to perform a rectal resection via a transanal endo­scopic approach without requiring access through the abdominal wall.
Cumulatively, the published data from case series on taTME demonstrate technical feasibility and preliminary oncologic safety in carefully selected patients. The quoted benets of a transanal endoscopic approach for very low rectal cancers in particular include the ability to expand the upper limit of intersphincteric resection under much improved visualization and exposure and the facili­tation of a complete rectal and mesorectal dissec­tion. This is especially helpful in male patients with narrow pelvises in whom a laparoscopic approach poses substantial technical difculty, with a high risk of conversion, as well as a high rate of poor quality, incomplete mesorectal excision.
The natural extension of the taTME movement has been to perform the entirety of the operation transanally; however, the general applicability outside of a few centers remains limited.
With the existing robotic platforms, which were originally designed for transabdominal sur­geries, proper working angles (and the inability to obtain them) represent an important limitation. Interesting developments in robotic surgery, as described above, promise to increase the ability to perform larger portions or even entire colorec­tal operations transanally. This has been demon­strated in cadavers by Marks, Ng, and Mak with transanal dissection and transection of the infe­rior mesenteric artery using the da Vinci SP Surgical System (Fig.17.7).
However, taTME in its current form using the available transanal platforms has several limita­tions. Lesions located in the upper rectum are more difcult to reach. The anastomosis in taTME for lesions at this level is more difcult due to inadequate visual exposure and requires endoscopic placement of the purse-string suture rather than by hand. Another major limiting fac­tor of pure NOTES is its extreme technical demand, including the preference for having two complete surgical teams to perform the operation (at most centers).
With the newly FDA-approved Single-Port da Vinci robot, the performance of transanal NOTES and its democratization in the surgical commu­nity will undoubtedly be facilitated.

Conclusions

An ideal platform for robotic TAMIS would have single-port access and exible camera and effector arms capable of triangulation for optimal visualization and ergonomics. Additionally, the system would be able to adapt and navigate itself along the circuitous path­ways of the distal gastrointestinal tract, reach­ing beyond the anal verge with the curve of the sacrum. The da Vinci SP, Flex® Robotic System, and STRAS robot realize some of these specications and will serve as high-util­ity platforms in the continued evolution of robotic TAMIS.
17 Transanal Robotic Surgery andFuture Directions
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Fig. 17.7 RTAS Transection of IMA. (a) After entry into the peritoneum, the arms of the da Vinci SP Surgical System retract the small bowel out of the pelvis. (b)

References

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2. Marks G, Bannon J, Marks J. Transanal-abdominal transanal radical proctosigmoidectomy with colo­anal anastomosis for distal rectal cancer. In: Baker R, Fisher J, Nyhus L, editors. Mastery of surgery. 3rd ed. Boston: Little, Brown and Company Inc; 1996. p.1524–34.
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Transanal inferior mesenteric artery dissection.(c) Transanal inferior mesenteric artery is clipped. (d) Transanal inferior mesenteric artery is transected
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9. Atallah S, Albert M, Larach S.Transanal minimally invasive surgery: a giant leap forward. Surg Endosc. 2010;24:2200.
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11. Lacy AM, Adelsdorfer C, Delgado S, Sylla P, Rattner DW. Minilaparoscopy-assisted transrectal low ante­rior resection (LAR): a preliminary study. Surg Endosc. 2013;27(1):339–46.
12. Leroy J, Barry BD, Melani A, Mutter D, Marescaux J. No-scar transanal total mesorectal excision – the last step to pure NOTES for colorectal surgery. JAMA Surg. 2013;148(3):226–30.
13. Chouillard E, Chahine E, Khoury G, Vinson-Bonnet B, Gumbs A, Azoulay D, Abdalla E. Notes total mesorectal excision (TME) for patients with rectal neoplasia: a preliminary experience. Surg Endosc. 2014;28(11):3150–7.
14. Marks JH, Lopez-Acevado N, Krishnan B, Johnson MN, Montenegro GA, Marks GJ.True NOTES TME resection with splenic exure release, high ligation of IMA, and side-to-end hand-sewn coloanal anastomo­sis. Surg Endosc. 2016;30:4626–31.
15. Atallah SB, Albert MR, deBeche-Adams TH, Larach SW. Robotic TransAnal minimally invasive surgery in a cadaveric model. Tech Coloproctol. 2011;15:461–4.
16. Atallah S, Parra-Davila E, deBeche-Adams T, Albert M, Larach S. Excision of a rectal neoplasm using robotic transanal surgery (RTS): a description of the technique. Tech Coloproctol. 2012;16:389–92.
17. Atallah S, Nassif G, Polavarapu H, et al. Robotic­assisted transanal surgery for total mesorectal exci­sion (RATS-TME): a description of a novel surgical approach with video demonstration. Tech Coloproctol. 2013;17:441–7.
18. Gomez Ruiz M, Martin Parra I, Calleja Iglesias A, Stein H, Sprinkle S, Manuel Palazuelos C, Alonso Martin J, Cagigas Fernandez C, Castillo Diego J, Gomez Fleitas M. Preclinical cadaveric study of transanal robotic proctectomy with total mesorectal
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19. Hompes R, Rauh SM, Hagen ME, Mortensen NJ. Preclinical cadaveric study of transanal endo­scopic da Vinci® surgery. Br J Surg. 2012;99:1144–8.
20. Atallah S, Martin-Perez B, Parra-Davila E, et al. Robotic transanal surgery for local excision of rectal neoplasia, transanal total mesorectal excision, and repair of complex stulae: clinical experience with the rst 18 cases at a single institution. Tech Coloproctol. 2015;19:401.
21. Gómez Ruiz M, Parra I, Palazuelos C, Martin J, Fernandez C, Diego J, Fleitas M. Robotic-assisted laparoscopic transanal total mesorectal excision for rectal cancer: a prospective pilot study. Dis Colon Rectum. 2015;58:145–53.
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TAMIS: Current Controversies andChallenges
HeatherCarmichael andPatriciaSylla
18

Introduction

Transanal minimally invasive surgery (TAMIS) is increasingly being used as an alternative to transanal endoscopic microsurgery (TEM) for transanal excision of both rectal adenomas and early rectal cancer. There are multiple ongoing controversies about the benets of and limita­tions of TEM and TAMIS. Given the relatively recent and limited experience with TAMIS as compared to TEM, published data on this plat­form is more limited, with no prospective series that compare the two platforms (and their respec­tive techniques) directly. What is known about the current controversies regarding TAMIS will be summarized in this chapter.
Local Recurrence andtheUse ofTAMIS forEarly Rectal Cancer
Arguably the most signicant ongoing contro­versy about both TEM and TAMIS is the appro­priateness of their use inlocal excision of early
H. Carmichael Department of Surgery, University of Colorado, Aurora, CO, USA e-mail: heather.carmichael@ucdenver.edu
P. Sylla (*) Division of Colon and Rectal Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA e-mail: patricia.sylla@mountsinai.org
rectal cancer. This debate is not specic to TAMIS, and much of the available evidence has been extrapolated from experience with TEM.Relative to the large body of literature on TEM, or even to published data on the transanal endoscopic operation (TEO), few studies have reported specically on TAMIS. Furthermore, there have been no prospective clinical trials comparing TEM and TAMIS and few studies reporting long-term follow-up for oncologic out­comes after TAMIS.
One review published by Martin-Perez etal. reviewed 390 TAMIS procedures encompass­ing 33 published retrospective case series as well as 3 abstracts [1]. Of these, over half of TAMIS procedures were performed for rectal adenocarcinoma, with adenoma representing the second most common indication. Margins were positive in 4.4% of cases overall, speci­men fragmentation occurred in 4.1%, and over­all morbidity was 7.4%. Larger TAMIS series have generally found similar short-term onco­logic results, supporting the conclusion that TAMIS is likely a safe alternative to TEM for carefully selected, T1 rectal cancer [19]. A matched analysis comparing 419 patients who underwent TEM and 228 patients who under­went TAMIS for both benign and malignant disease found no differences in the rates of pos­itive margins or lesion fragmentation, again suggesting similar results for the two operative platforms [10].
© 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_18
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In terms of local recurrence, in a retrospective series of 50 patients undergoing TAMIS excision for rectal cancer, Albert etal. reported one case of local recurrence in a patient with a pT1 tumor (6.3% of all pT1 lesions reported) with a mean follow-up of 20 months [8]. Lee et al. and McLemore etal. reported a series of 25 and 34 patients undergoing TAMIS with no cases of local recurrence but with only short-term follow­ up (9.8months or 3–23weeks, respectively) [3,
11]. Schiphorst et al. in a series of 37 patients
found one case of local recurrence for a pT1 lesion (25% of pT1 lesions) with 11months mean follow-up [12]. In a recent series of 50 patients by Caycedo-Marulanda et al., there were two cases of local recurrence (6%) after TAMIS for early rectal cancer, with a median follow-up of 21months [13]. More recently, Lee etal. reported outcomes of 200 TAMIS cases for local excision of rectal neoplasia from the center that estab­lished TAMIS as a technique (Orlando, FL, USA). The authors reported a 7% overall margin positivity and 5% rate of specimen fragmenta­tion. Of 110 malignant lesions excised using the TAMIS technique, 6% recurred locally, and 2% presented with distant organ failure (follow-up was 14.4months) [14]. Overall, these results sug­gest that local recurrence after TAMIS for early rectal cancer is similar to TEM; however, large series with long-term oncologic outcomes are lacking.
Technical Limitations withtheTAMIS Platform: Low andHigh Rectal Lesions
TAMIS, given the shorter length of the dispos­able platform, is generally limited to the rst 8–10cm from the anal verge. Beyond this point it becomes difcult to provide adequate retrac­tion to visualize upper rectal lesions, particularly those located behind and beyond the rectal valves [15].
TEM and TEO, on the other hand, have rigid rectoscopes as long as 15–20 cm in length [16,
17]. While these platforms may be limited by a
narrow rectosigmoid junction or other anatomical
constraints, TEM and TEO generally allow the surgeon to stent past the rectal valves to access high rectal tumors [18]. This underscores a fun­damental difference between the two platforms; as with TEM and TEO, the access channel (shaft) itself is advanced to the target lesion, whereas, with the TAMIS technique, the access channel remains in the same position, and, instead, only the laparoscopic instruments are navigated to the target lesion.
TAMIS, on the other hand, is limited in access to very low rectal tumors because the TAMIS transanal port occupies the rst several centime­ters of the anal canal [19]. The TEM platform, by virtue of being secured to the operative room table, can be withdrawn to the level of the anal verge itself, allowing access to very low rectal tumors [18]. A hybrid approach can be used with TAMIS for these low lesions, dissecting the distal margin using a conventional transanal approach with retractors, followed by insertion of the TAMIS port for the proximal dissection [20].
Peritoneal Entry inTAMIS Versus TEM
Peritoneal entry during transanal endoscopic sur­gery is not uncommon and is not usually consid­ered a complication, so long as the surgeon can adequately repair the defect without conversion to a transabdominal procedure. For TEM, the rate of peritoneal entry in the reported literature var­ies widely from 0% to 32.3% [2123]. More recent series with over 300 patients have demon­strated lower rates of 5–10.7% [24, 25]. However, expanding indications for TEM and TAMIS including the increasing use for resection of more proximal, anterior, and circumferential tumors have the potential to make peritoneal perforation a more common occurrence over time [23, 26].
The loss of pneumorectum that occurs follow­ing peritoneal entry can impede visualization and retraction, presenting a signicant technical chal­lenge for the surgeon. Prone positioning of the patient with a high anterior lesion can help to min­imize the impact of CO nal cavity should peritoneal entry occur [26].
leakage into the abdomi-
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