Transanal Total Mesorectal Excision: The Work Is Progressing Well Andre D’Hoore, M.D.1 • Albert M. Wolthuis, M.D.1 • Dana R. Sands, M.D.2 Steven Wexner, M.D., Ph.D. (Hon.), F.A.C.S., F.R.C.S., F.R.S.C.(Edinb.)2 1 Department of Abdominal Surgery, University Hospital, Leuven, Belgium 2 Department of Colorectal Surgery, Digestive Disease Center, Cleveland Clinic Florida, Weston, Florida


he development of laparoscopic surgery has changed the practice of colorectal surgery. In view of different significant short- and long-term benefits and equivalence or, in some instances, superiority of oncologic efficacy, a minimally invasive approach is now the standard of care for colorectal cancer surgery. However, owing to a steep learning curve, implementation has been a long process. Specifically, laparoscopic total mesorectal excision (TME) has specific technical hurdles, which in some cases have resulted in significant conversion rates.1,2 Conversion has been linked to increased postoperative morbidity and worse oncologic outcome.1,2 Previous unsubstantiated claims have indicated that robotic surgery could overcome these theoretical difficulties. However, at the recent annual meeting of the American Society of Colon and Rectal Surgeons in Boston, MA, in June 2015, Alessio Pigazzi presented the results of the multicenter multinational randomized controlled Robotic versus Laparoscopic Resection for Rectal cancer (ROLARR) trial that included 471 patients. He reported that the ROLARR trial failed to demonstrate any statistically significant advantage conferred by the robotic approach. (unpublished data). Another option to overcome some of the potential challenges of ultralow laparoscopic distal rectal mobilization is to mobilize this part from below, the so-called transanal TME (taTME). Earlier editorials by the senior author have cautioned interested surgeons to devote appropriate time and attention to master the technique to help improve results.3,4 This article explores the Financial Disclosures: Dr Wexner has received consulting fees and royalty payments from Karl Storz Endoscopy America, and royalty payments from Covidien. Correspondence: Steven D. Wexner, M.D., Ph.D. (Hon.), F.A.C.S., F.R.C.S., F.R.S.C.(Edinb.), Chairman, Department of Colorectal Surgery, Digestive Disease Center, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL 33331. E-mail: [email protected] Dis Colon Rectum 2016; 59: 247–250 DOI: 10.1097/DCR.0000000000000508 © The ASCRS 2015 Diseases of the Colon & Rectum Volume 59: 3 (2016)

value of taTME in view of the current literature and the personal experience of each of the authors.

LAPAROSCOPIC TME Various technical difficulties are inherent to laparoscopic TME including the need for good visualization by atraumatic retraction during distal rectal mobilization. Inadvertent breaches into the mesorectal fascia during such transabdominal retraction are associated with a subsequently increased risk of local oncologic failure. The bony boundaries of the pelvis, especially in the right anterolateral dissection plane, limit the possibility of the laparoscopic instruments to obtain optimal angulation of the tip of the instruments to secure a technically complete dissection. Distal rectal transection using laparoscopic stapling devices may potentially be technically difficult; in these instances, a transanal dissection, specimen delivery, and anastomosis may be undertaken.5,6 With the use of augmented reality reconstruction, it has been demonstrated that a stapler inclination of at least 65° is required.7 As a consequence of the suboptimal angle, different stapling firings are often required to transect the distal rectum. The need for more than 2 firings has been linked to an increased risk of anastomotic leakage.8 These technical difficulties are even more evident in male and obese patients and have demonstrated increased morbidity and conversion to laparotomy rates.9 Moreover, they have hampered the implementation of a laparoscopic approach to TME. In the PROCARE rectal cancer registry, the increase from 22% to 38% in the use of laparoscopy was noted over a 5-year period, while an overall 17% conversion rate to laparotomy was noted.10 Two main “work around” methods have been used to try to reduce or obviate some of these challenges: hand-assisted surgery and robotic surgery.11 Hand-assisted surgery results in a larger than laparoscopic incision but potentially reduces operative times Robotic surgery requires the placement of at least two additional trocars and significantly longer operative times 247

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For Debate

resulting in significantly higher cost. Thus, neither of these methods has been universally a­ ccepted as a panacea.

PRECLINICAL STUDIES In 2007, Whiteford et al12 described the feasibility of a natural orifice transluminal endoscopic surgery (NOTES) radical sigmoidectomy using the rigid transanal endoscopic microsurgery (TEM) platform (referred to as a “proto-NOTES” platform) in human cadavers. In a recent comparative study in cadavers, the same authors concluded the need for adapted instrumentation, because colonic mobilization using the conventional rigid TEM instrumentation was insufficient.13 In 2008, Sylla et al14 explored the feasibility for NOTES transanal rectosigmoid resection with and without transgastric endoscopic assistance in a porcine model. Although the transgastric approach significantly prolonged the procedure, it allowed more extensive mobilization of the left colon. These preliminary studies clearly indicate the need for a hybrid transanal procedure to allow proximal vascular control and splenic flexure mobilization. These efforts resulted in the first hybrid NOTES transanal rectal cancer resection using laparoscopic-assisted TEM.15 Moreover, Zhang et al16 and subsequently Leroy et al17 described pure transanal NOTES TME as a promising step to NOTES colorectal surgery.

TRANSANAL TME The concept of taTME is not new; working with Gerald Marks, Bannon et al18 first described the open transanal abdominal transanal approach over 30 years ago. taTME is the next incremental evolution in the minimally invasive approach to TME surgery, merging 3 different recent concepts: laparoscopic transanal abdominal transanal resection5,19; TEM, first pioneered by Buess and colleagues20,21; and natural orifice specimen extraction (NOSE).22 Since the advent of rigid-platform TEM, other methods have been popularized including transanal endoscopic operating and transanal minimally invasive surgery (TAMIS).23,24 TAMIS relies on a flexible rather than a rigid platform. All these methods can be referred to generically as transanal endoscopic surgery (TES), and each platform has its respective proponents.25,26 Performing an extraluminal dissection (after having closed the rectal tube) allows for transanal dissection of the external mesorectal fascia – a hybrid laparoscopic approach. The bottom-up dissection can be extended in a cephalad direction to the level of the sacral promontory (posterior) and to the fold of Douglas (anterior). The extent of transanal dissection to have a “rendezvous” with the laparoscopic dissection can be variable and should be tailored (Fig. 1).27 Depending of the level of closure of the rectal tube, a stapled or handsewn anastomosis can be performed. After full colonic mobilization, a transanal extraction of the specimen can be

FIGURE 1.  Posterior dissection: the mesorectum is lifted. The pursestring closing the rectal tube is visible. The presacral space has been opened, and the coccyx shines through. The lateral sacral nerve plexus is indicated by a black arrow.

performed (NOSE). Different transanal ports are currently in use or are being developed and offer an ergonomic platform to perform the dissection. Furthermore, the incorporation of a valveless high-flow trocar system to supply constant flow of carbon dioxide results in a stable pneumopelvis, avoiding “flapping” of the specimen and loss of visualization.28

ADVANTAGES OF TATME A transanal approach avoids the most cumbersome phase of a laparoscopic approach to the distal mesorectum. Transanal access using an adapted transanal port provides an ergonomic platform to facilitate dissection of the retroperitoneal part of the rectum. This goal can be achieved without any traction on the specimen. Furthermore, and even more importantly, the surgeon has more visual control of the distal resection margin, potentially resulting in a reduction of positive distal resection margins. In the first case-controlled study, Fernandez-Hevia et al29 reported a significant longer distal resection margin in the taTME group. Several more recent studies have confirmed this finding.30,31 Depending on the level of the tumor according to the Rullier classification of distal rectal cancer, different levels of transection and anastomosis are needed. Either a sleeve mucosal and/or a partial intersphincteric resection can be performed.32 The technique is equally appropriate to perform a sleeve mucosal and/or partial intersphincteric resection. A distal pursestring will close the distal stump and allow a single stapled anastomosis (independent of the chosen mode of reconstruction: side-to end, end-to-end, or colonic pouch). Whether this method could result in a significantly decreased leak rate, and consequently in the need for a temporary ileostomy, is of major interest. In addition to the benefit noted in the distal resection margin, recent studies have also shown a statistically significant improvement in the quality of the mesorectal dissection when combining the taTME with a laparoscopic colon mobilization.33 Finally, provided a complete left colonic mobilization has been performed, the

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Diseases of the Colon & Rectum Volume 59: 3 (2016)

specimen can be retrieved through the anal canal (NOSE), thereby avoiding the need for any additional suprapubic or other abdominal incisions. Short- and long-term benefits linked to NOSE have been reported.34,35 Combining a laparoscopic approach with a transanal approach has the potential to eliminate the need for conversion to laparotomy. This advantage was clearly demonstrated in the series by Rouanet et al,36 who implemented this technique in obese and male patients. Therefore, the TaTME could potentially relegate robotic TME to an unjustifiably costly alternative. In addition to the ROLARR trial having definitively proven that the robotic approach fails to confer any statistically significant benefit, Park et al presented a series of 334 patients who underwent robotic surgery for rectal cancer.37 They quite appropriately concluded that the robotic approach is “currently too expensive with no short term advantages”. The initial capital required for the robotic system is between $1.75 and $2.25 million with a costly annual service contract. This cost, coupled with the disposable instruments, can add more than $3000 to each procedure.36 A meta-analysis of the 2 techniques yielded equivalence with respect to distal transection margin, mesorectal completeness, and complications.38 A common reason for conversion is the inability to gain proper traction deep within the narrow pelvis. taTME obviates the need for this portion of the dissection with the abdominal approach. taTME brings the surgeon directly to the distal pelvis, offering superior visualization and direct dissection without the need for extreme angulation of laparoscopic instrumentation. Extrapolating from the findings of Lacy et al30 and Velthuis et al,33 including improved quality of the mesorectal dissection and distal margin when combining laparoscopy and a taTME compared with standard laparoscopy, may lead surgeons to question the utility of a costly robotic dissection for TME.39 taTME combined with a laparoscopic approach may add little cost if a rigid reusable port is used. Even if the disposable TAMIS port is used, the shorter operative times enabled by a synchronous combined approach may still help realize cost savings. All the coauthors of this document routinely and regularly practice taTME with the synchronous approach.

REQUIRED SKILLS AND LEARNING CURVE Different skillsets are required to safely implement taTME. Because the procedure is a hybrid laparoscopic approach, advanced laparoscopic skills and experience with laparoscopic colonic and rectal resections are required. Furthermore, the surgeon should be trained in coloanal anastomosis and have experience with sleeve resections. Finally, basic skills for and experience with TES are necessary to allow a safe transanal approach. Different skills laboratories have been offered for surgeons to acquire confidence with the TES. There are pitfalls that are linked to transanal resection and are inher-

ent to other anatomic landmarks. Recently, 2 publications specifically ­highlighted the anatomic peculiarities of this approach.40,41 An off-course anterior dissection puts the bulbar urethra at risk. Indeed, in the pilot series of Rouanet et al,35 2 urethral lesions occurred in a series of 30 patients. A too lateral dissection easily directs the surgeon lateral to the pelvic nerve plexus and can lead not only to autonomic nerve damage (sacral nerve plexus), but also to major vascular (internal iliac vein) and ureteral injuries. Therefore, it is of paramount importance to distinguish the plane between the mesorectal fascia and the presacral fascia posteriorly, and Denonvilliers fascia and the prostate capsula or dorsal vaginal wall anteriorly. The lateral dissection margins are more subtle and should respect the pelvic nerve plexus. From our own combined experience, a dissection beginning at the anorectal junction (just above the level of the puborectal muscle) is more straightforward than a sleeve resection.

CONCLUSION Minimally invasive taTME combines laparoscopic techniques with NOSE and TES. It has the potential to overcome the inherent limitations of a purely laparoscopic TME. Direct visual control of the distal resection margin is a major asset to improve oncologic outcome in mid and distal rectal cancer. The learning curve should be limited to teams of surgeons who have mastered laparoscopic surgery and TES. Although taTME seems most appropriate for obese males and/or patients with distal rectal carcinoma, it may have significant value in more proximal rectal cancers, in asthenic patients, and even in patients with benign disease. The hopefully soon to be launched American Society of Colon and Rectal Surgeons Research Foundation Transanal TME registry should help clarify some of these questions. REFERENCES 1. van der Pas MH, Haglind E, Cuesta MA, et al; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013;14:210–218. 2. Guillou PJ, Quirke P, Thorpe H, et al; MRC CLASICC trial group. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet. 2005;365:1718–1726. 3. Wexner SD, Berho M. Transanal total mesorectal excision of rectal carcinoma: evidence to learn and adopt the technique. Ann Surg. 2015;261:234–236. 4. Wexner SD, Berho M. Transanal TAMIS total mesorectal excision (TME)–a work in progress. Tech Coloproctol. 2014;18:423–425. 5. Person B, Vivas DA, Wexner SD. Totally laparoscopic low anterior resection with transperineal handsewn colonic J-pouch anal anastomosis for low rectal cancer. Surg Endosc. 2006;20:700–702. 6. Wexner SD, Edden Y. NOTES/NOSE/NOSCAR/LATAS: what does it all mean? Tech Coloproctol. 2009;13:1–3.

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Transanal Total Mesorectal Excision: The Work is Progressing Well.

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