As we’ve done since 2010, Steven D. Wexner, MD, PhD, and I collaborated on the annual Dueling Debates in Colorectal Surgery. With special thanks to Dr. Wexner for lending his time, expertise and opinions, I present current debates in colorectal surgery, including stoma reinforcement with mesh, neoadjuvant chemoradiation for rectal cancer, robotic taTME, and whether watch and wait after complete response of rectal cancer to chemoradiotherapy is the standard of care.

Read on, take a side, access On the Spot online, and share your view with a comment. Feel free to send me any ideas for column topics at colleen@cmhadvisors.com. Happy reading!

—Colleen Hutchinson

Colleen Hutchinson is a medical communications consultant at CMH Media, based in Philadelphia. She can be reached at colleen@cmhadvisors.com.

Framing the Debates

I am grateful to Colleen Hutchinson for again allowing me to enlist the support of my colleagues for this excellent edition of Dueling Debates in Colorectal Surgery. This year I have selected five current controversial topics, and in some instances, more than two dueling debaters. I endeavored to select a wide range of dilemmas and enlist an equally diverse group of debaters.

The section begins with Mr. Neil Smart from the United Kingdom arguing for use of prophylactic mesh during the creation of stomas, at least in appropriately selected cases. Dr. David Beck, formerly of the Ochsner Clinic and more recently at Vanderbilt University, tends to disagree, and offers perhaps a more highly selective approach. Although these two individuals do not have diametrically opposed views, Mr. Smart appears more liberal in the use of mesh than Dr. Beck.

The second topic pits Dr. Julie Ann Van Koughnett from Ontario against Dr. Nancy You from MD Anderson Cancer Center. While Julie Ann believes the data are not yet fully mature to convince her that all chemotherapy should be given in advance of surgery, Dr. You offers compelling data as to why she is a strong proponent of “all up-front” chemotherapy.

The third topic positions Dr. John Marks from Lankenau Medical Center against Dr. Matthew Albert from Adventist Health System and Dr. Patricia Sylla from Mount Sinai Medical Center. Perhaps the fact that Dr. Marks is pro-robotic and both Drs. Albert and Sylla disagree with the superiority of the robotic approach to transanal total mesorectal excision (taTME) attests to the fact that more work is required, both manually when performing taTME as well as when debating the subject. On a more serious note, these three surgeons have a vast experience in taTME and offer their own unique perspective.

In the fourth subject, Dr. Marylise Boutros from McGill University notes that wait and watch is “almost” a standard of care, whereas Dr. Craig Messick from MD Anderson Cancer Center believes that although the wait-and-watch approach is an “option,” it is not yet a standard of care.

Lastly, addressing a more global topic, Dr. Antonio Lacy from Barcelona, Spain, offers his passionate view about video-based education, whereas both Dr. Deborah Keller from Columbia University and Dr. Tracy Hull from the Cleveland Clinic in Ohio share their perspectives on why video-based education, although a part of education, does not substitute for other learning methods.

I wish to thank all of the participants in this year’s Dueling Debates in Colorectal Surgery for their time, expertise and succinct cogent comments supporting their views. I am confident that the readers of General Surgery News will find this article very enjoyable to read as well as thought-provoking.

—Steven D. Wexner, MD, PhD (Hon)

1. Stomas should be reinforced routinely with mesh.

Agree: Agree—with caveats!Parastomal hernias (PSH) are very common and frequently cause significant symptoms associated with reduced quality of life. As there is no gold standard technique or mesh for the repair of PSH, the focus has been on prevention. No stoma creation technique has been reliably proven to reduce PSH development until prophylactic mesh was first investigated more than 30 years ago. Over the past 20 years, prophylactic mesh placement at the time of index stoma formation has been studied extensively in over 10 randomized controlled trials and more than 12 meta-analyses. The relative risk reduction of approximately 60% in PSH formation with retrorectus macroporous permanent synthetic mesh is cost-effective and has a good safety profile.

The caveat is that the data overwhelmingly pertain to permanent end colostomies formed during elective cancer surgery only. Evidence for stomas created for inflammatory bowel disease and functional and diverticular patients is lacking, and ileostomies are almost wholly absent from the literature. There is disparity in the guidelines from several professional societies (the European Hernia Society, the Association of Coloproctology of Great Britain, Cochrane) regarding the advocacy of prophylactic mesh, and this reflects methodological limitations of the randomized controlled trials performed thus far. The evidence may be considered as showing benefit for prophylactic mesh on the balance of probability rather than beyond reasonable doubt.

Disagree: Mesh reinforcement is considered to reduce the incidence of PSH. The reported incidence has been variable, and not all PSH need to be treated. While reinforcement can reduce the incidence of PSH, it does not eliminate it. There is also a significant cost associated with reinforcement, and there is no consensus on the best technique of reinforcement or what is the best material for reinforcement. In the absence of good convincing data, I would favor a selective approach, only reinforcing patients with significantly higher risk for PSH (large stomas, thin abdominal wall, younger age, with active lifestyles, etc.).

2. Chemoradiation for rectal cancer should be neoadjuvant.

Disagree: I like a challenge, but this is certainly a tough statement with which to disagree! When considering neoadjuvant chemoradiation for rectal cancer, there are numerous tumor and patient factors to consider. While neoadjuvant chemoradiation provides a recurrence benefit, one must be thoughtful and consider the consequences with the patient and multidisciplinary cancer team before embarking upon it. For those with midstage disease, higher rectal tumors and clear circumferential resection margins, chemoradiation may be avoided altogether. As demonstrated by the MERCURY study group [Ann Surg 2016;263(4):751-760] and the recent QuickSilver trial [JMIR Res Protoc 2015;4(2):e41. doi:10.2196/resprot.4151], the value of neoadjuvant chemoradiation should be weighed against the low recurrence and positive circumferential resection margin rates in favorable tumors and avoided in some patients. In addition, preoperative short-course radiation without chemotherapy is a suitable alternative when downstaging is not required, when margins are not threatened, and when patients prefer it. Forgoing long-course chemoradiation is not insignificant; it leads to a shorter overall treatment course and fewer radiation-related side effects. We wisely fear the consequences of adjuvant radiation, namely, anastomotic stricture and poor function. However, with reliable expert radiologists (or ultrasonographers), the surgeon should trust the preoperative staging and consider taking the patient straight to surgery, rather than relying on chemoradiation to optimize oncologic outcomes, where clinically appropriate.

Agree: The optimal timing of chemoradiation for rectal cancer should maximize oncologic benefit while minimizing toxicity for the greatest number of patients. Chemoradiation is given for patients with rectal cancer to enhance the local control offered by optimal surgery alone. The magnitude of this benefit depends on the risk for local failure with surgery. We estimate that this risk is increased in tumors that are of a higher clinical stage (i.e., cT and cN), show threatened circumferential resection margin (i.e., encroachment of malignant tumor and/or nodes near the mesorectal fascia), and lie closer to the anal verge (i.e., many structures in close proximity). Thus, we give chemoradiation to these high-risk tumors. However, chemoradiation carries side effects: pain, diarrhea, acute proctitis and poor healing in the short term, and bowel dysfunction, sexual and urinary dysfunction, fistula, stricture, osteoporosis, and others in the long term. Because the German Rectal Cancer Trial established that the toxicity rates of preoperative (neoadjuvant) chemoradiation are significantly lower than those of postoperative chemoradiation, I think it should be given neoadjuvantly when oncologic benefit has been estimated.

Where would such a policy of neoadjuvant chemoradiation fall short? Despite the best clinical staging tools, clinical staging (i.e., our estimation of the above risk factors, including clinical T and clinical N staging) remains imperfect, when compared with the gold standard of pathologic staging. This means that there will be a subset of patients whose clinical stage and risk for local failure are overestimated. If chemoradiation is always given neoadjuvantly, these are the patients who will bear the toxicity of treatment without having much benefit (i.e., if their risk could have been known to be zero with total accuracy, they could have been safely spared of any toxicity).

Let’s consider the alternative: We could do surgery first and get accurate pathologic staging in all, and give chemoradiation postoperatively only to those patients with high pathologic T and N stage and with close surgical margins. This would mean that the patients with high-risk tumors would bear the significantly higher level of treatment-associated toxicities associated with postoperative chemoradiation. There is also the risk that postoperative complications may preclude some patients from receiving postoperative therapy. The bottom line: Because clinical staging is correct more than 50% of the time, and because the toxicity of postoperative chemoradiation is nearly double of that given preoperatively, I favor neoadjuvant chemoradiation as a whole. For an individual patient in a specific practice setting, however, there would be room for individual assessment, balancing the accuracy of clinical staging, the estimated risk for local relapse, the ability for the patient to tolerate the toxicities of chemoradiation, and the anticipated risk for operative morbidity that may prohibit postoperative treatment.

3. Robotic taTME is superior to manual taTME.

Agree: I agree that robotic taTME allows superior visualization, retraction and mobilization compared with manual taTME. To me, taTME is an operation reserved for cancers of the distal third of the rectum. The operation starts as a TATA [transanal abdominal transanal procedure] with the intersphincteric dissection carried up to the mid-prostate or vagina, and the rectum is then oversewn. At this point, we have traditionally placed a Gelpoint Path [Applied Medical] with a flexible-tip laparoscope and two additional ports in order to facilitate dissection. While workable, this is a challenging arrangement for both the surgeon and assistant. Constant instrument collisions and positioning two people to work instruments between the legs represent significant drawbacks to the approach. The daVinci single-port robot [Intuitive Surgical], meanwhile, allows beautiful 3D visualization, excellent retraction with three arms, and the ability to comfortably operate in a difficult region for both the surgeon and assistant. The cautery and bipolar devices are more than effective for hemostasis in this region. The vision, the ability to move the platform easily under your direction, and the extended retraction of the three arms with flexible retractable articulations make this an ideal tool and approach for taTME. All previous iterations of robotic taTME were impossibly limited by the conflicts of arms, which are entirely avoided in the single-port robot. It’s clear that this will be the standard way in the future.

Disagree: Shortly after the development of TAMIS [transanal minimally invasive surgery] and improved transanal access ports, we quickly turned our interest to robotic integration in an honest attempt to overcome the challenges of ergonomics and suturing in the rectum. Although the newer daVinci Si system [Intuitive Surgical] is more versatile, it still exposes all of the limitations and challenges of the large robotic footprint, requiring a PhD in docking, and somewhat fixed rigid robotic arms, requiring frequent manipulation. Robotic TAMIS in studies demonstrates longer operating times and increased cost without any additional patient benefit.

On the other hand, there is minimal experience worldwide with robotic taTME, other than case reports. However, with the development of the daVinci single-port robot, this becomes debatable. Although not FDA approved for colorectal surgery, early experimental use is extremely promising. The single-port robot will indisputably improve the visualization, retraction, exposure, instrumentation and access to the abdomen to facilitate a complete taTME. However, as with all robotic debates, we must consider cost and value. Do I want one? Yes! Will we ever be able to scientifically demonstrate improved outcomes significant enough to justify the cost? Impossible!

Disagree: As reflected in several recently published international expert consensus statements, taTME is a technically arduous procedure that should be performed by well-trained transanal surgeons at high-volume rectal cancer centers of expertise (Surg Endosc 2018;32[3]:1091-1103; Surg Endosc 2017;31[7]:2711-2719). The taTME learning curve has been estimated at around 40 to 51 cases (Tech Coloproctol 2018;22[4]:279-287; Surg Endosc 2018 Jul 11. doi: 10.1007/s00464-018-6360-4), which translates into a two-year or longer learning curve for most rectal cancer surgeons performing an average of 20 to 25 taTME cases per year.

While robotic technologies may facilitate taTME dissection by enhancing visualization, intraluminal navigation and articulation of instruments within the confined perirectal space, the learning curve will not be shortened, but will actually lengthen due to the prerequisite rigorous training on new robotic platforms.

Besides short-term results demonstrating the oncologic adequacy of taTME, the most important benefit of taTME has been the exceedingly low reported rates of conversion to open surgery (0%-6%), well below that of laparoscopic or robotic TME, even for low rectal tumors and by surgeons early along their learning curve (Ann Surg 2019;269[4]:700-711). It is highly unlikely that the robotic approach will further lower conversion rates or improve perioperative or oncologic outcomes. However, robotic technologies will undoubtedly increase procedural time and per-case costs.

Finally, it would be unrealistic to expect that the robotic approach will enable adoption of taTME. Safe implementation of taTME is tightly linked to expertise in minimally invasive TME, transanal endoscopic surgery and adherence to the recommended structured taTME training pathway. Proctorship of the initial cases is also strongly advocated to enable early feedback and prevent early and late complications. As a matter of fact, the most challenging obstacle to safe implementation of taTME worldwide has been the variable adherence to the recommended structured training pathway, unavailability of proctors or reluctance to seek proctorship. Unless new-generation robotic endoluminal platforms are equipped with built-in telementoring features that enable direct feedback, or enhanced localization capabilities such as image guidance to facilitate intraoperative identification of anatomic landmarks, it remains highly unlikely that robotic taTME will improve clinical outcomes, shorten the learning curve, reduce costs, or enable adoption of this complex procedure.

4. Watch and wait after complete response of rectal cancer to chemoradiotherapy is a standard of care.

Agree: It’s almost there. Watch and wait after complete clinical response (cCR) of rectal cancer to neoadjuvant chemoradiation is a very promising strategy that allows patients to avoid the morbidity of surgery. While rectal cancer surgery has advanced tremendously, it’s still not without consequences: bowel dysfunction (>70%), sexual/urinary dysfunction (>50%), and need for temporary/permanent stoma (>75%). After standard neoadjuvant chemoradiation, 12% to 25% of patients will have cCR—no clinically apparent tumor. Evidence from many observational studies with long-term follow-up of watch-and-wait surveillance programs shows that approximately 20% of these patients will have local regrowth, with salvage surgery possible in 95% (remaining 5%: one-third declined surgery, one-third were unfit for surgery, and one-third had distant metastases). Furthermore, overall survival (92% three-year survival) and rates of distant metastases (5%) are equivalent in patients who are watched (with/without salvage surgery) and those with pathologic complete response after total mesorectal excision.

However, there are some aspects of this strategy that require refinement. Selection criteria, more accurate indicators of cCR, standardization of surveillance and optimal chemoradiation protocols to improve rates of complete response with an acceptable toxicity profile are all areas under exciting development. I strongly believe that watch and wait will soon take its place within a new standard of individualized rectal cancer care.

Disagree: Despite the gain in worldwide interest and support, its employment as a standard of care management strategy should be approached with caution. Whereas limited prospective and many retrospective studies support its use, its consideration on a clinical trial and off-protocol use should be clearly documented as such with proper risk discussion. The fact is, there are insufficient data demonstrating “no harm” to watch and wait. Renehan et al published their OnCoRe project results from a propensity score matched cohort in the Lancet Oncology in 2016 [17(2):174-183]. Their data included 98 patients and revealed a three-year actuarial regrowth rate of 38% for watch and wait, and no differences in three-year non-regrowth disease-free survival between watch-and-wait and resection patients, but 12% of patients were unable to be surgically salvaged—alarming. These and other data are encouraging, but too variable. Given that we can’t reliably predict pathologic complete response from cCR and the cost of being wrong is too high compared with the benefit of radical surgery, incorporating watch and wait as a standard of care should be considered premature. Data that drive our effort for clinical excellence should be unified, from unbiased randomized trials, and revolve around a shared decision with patients. Option? Yes. Standard of care? Not yet.

5. Video-based education to learn a new procedure is adequate for a practicing surgeon.

Agree: Although it is difficult to think that online education could end with traditional training systems, especially in the surgical field where procedural skills are so essential, the technological innovations, the demand on results and the restriction in surgical training hours have given value to complementary training methods. Education from surgical videos provides an excellent opportunity for training in procedures, allowing the practicing surgeon to visualize the steps indefinitely, and even memorize them. This is very important when it comes to learning a technique because before innovating, one must have performed an intervention hundreds of times. Besides, the videos allow analyzing technical mistakes and serve as a personal follow-up to improve surgical education. Video-based education does not replace clinical training but offers a realistic and efficient tool for the lifelong process of learning surgical skills.

Disagree: Video-based education is a valuable and important part of the pre-learning phase of learning, but is not sufficient on its own for the practicing surgeon to implement a new procedure safely into practice. A wet and dry lab, and proctoring along the learning curve, is also important for the best patient outcomes.

Disagree: The nuances of a new procedure require feedback from someone more experienced. Watching a video can give an overview and a sense of what to do, but for most surgeons, it will not provide adequate instruction to safely perform a new procedure. If video-based education were enough, we would need neither surgical residencies nor fellowships. The learner could simply watch a video and be adequately prepared to start doing surgery.

GUT REACTION
	Most critical new advance in my area of medicine	FDA approval process for medical devices and drugs	Most challenging issue my counterparts and I face today	My mentor	Best part of my job	Tool or device in my clinical arsenal I can’t live without	The robot in colorectal surgery is …
Mr. Neil J. Smart	Genomics	Inadequate	Brexit	Mark Mercer-Jones and Ian Daniels	Patients	The multidisciplinary team	Expensive, but possibly the future
Matthew R. Albert, MD	Induction chemotherapy for rectal cancer	Challenging, and becoming more stringent	Burnout, electronic health records	Steve Schwaitzberg, Randy Bailey	Operating; satisfied patients	Transanal port/Gelpoint Path (Applied Medical)	Polarizing
Tracy Hull, MD	Organized teamwork for patient care	Needs to be rethought	Unnecessary paperwork plus electronic health records	Crucial for my professional development	The feeling after completing a very difficult operation	Bovie (Bovie Medical)	Still evolving
Patricia Sylla, MD	Total neoadjuvant therapy for rectal cancer	Overreliance on randomized controlled trials obstructs access to important technologies	Training the next generation in novel techniques/technologies	Steve Wexner, MD	When a patient has a chance at avoiding a permanent stoma	Colonoscope	Another surgical tool in the surgeon’s armamentarium
Deborah S. Keller, MD	Image-guided surgery	Can slow progress without adding safety benefits	Dealing with electronic health records; draining and cumbersome	Is a constant inspiration and drives me forward	Having patients come back into clinic after surgery happy	My laparoscope and laparoscopic instruments	A valuable MIS tool
Julie Ann Van Koughnett, MD	Advanced MIS tools	Challenging	Managing surgical resources	Steven Wexner and others at Cleveland Clinic Florida and Western	Seeing trainees flourish	My headlight	The future
Marylise Boutros, MD	Technical: transanal endoscopic surgery; Science: microbiome	Necessary. Critical. Arduous.	Healthy and happy work–life balance	Dr. Wexner—forever grateful to him, as are many, many others!	The people! Daily interaction with patients, residents, students, mentors and colleagues	The laparoscope!	Not quite there yet, but future is exciting
David E. Beck, MD	Perioperative case (care paths)	Very slow and expensive	Increased documentary requirements	Almost all have died	Interacting with patients	EnSeal (Ethicon Endo-Surgery)	Slow and not cost-effective
John H. Marks, MD	Single-port robot	Important, but needs to occur more quickly and responsively	Continued innovation in times of cookbook protocols	Cristiano Huscher, Joel Leroy and, of course, Gerald Marks	Seeing happy patients postoperatively	LigaSure (Medtronic)	An excellent tool whose potential needs development
Nancy You, MD	Risk-tailored treatment approaches	Better for drugs than devices	Biased information on social media	Heidi Nelson, MD	Serving my patients through a time when they feel scared and vulnerable	Computer	Is a great tool
Craig A. Messick, MD	Watch and wait for rectal cancer, checkpoint inhibitors	Agree, for patients’ safety	Alarmingly high rates of younger colorectal cancers	George Chang and my other seven MD Anderson partners	Talented colleagues, amazing patients, hating cancer, prevention focus!	Flexible sigmoidoscopy	Selectively useful tool in the surgical toolbox