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26 Management ofLow Rectal Cancer After Complete Clinical Response
complete clinical response after neoadjuvant therapy: results of a decision-analytic model. Dis Colon Rectum. 2015;58(2):159–71.
41. Habr-Gama A, Gama-Rodrigues J, Sao Juliao GP, Proscurshim I, Sabbagh C, Lynn PB, etal. Local recurrence after complete clinical response and watch and wait in rectal cancer after neoadjuvant chemoradiation: impact of salvage therapy on local disease control. Int JRadiat Oncol Biol Phys. 2014;88(4):822–8.
42. Habr-Gama A, Perez RO, Proscurshim I, Nunes Dos Santos RM, Kiss D, Gama-Rodrigues J, et al. Interval between surgery and neoadjuvant chemoradiation therapy for distal rectal cancer: does delayed surgery have an impact on outcome? Int JRadiat Oncol Biol Phys. 2008;71(4):1181–8.
43. Habr-Gama A, Sabbaga J, Gama-Rodrigues J, Sao Juliao GP, Proscurshim I, Bailao Aguilar P, et al. Watch and wait approach following extended neoadjuvant chemoradiation for dis­tal rectal cancer: are we getting closer to anal cancer management? Dis Colon Rectum. 2013;56(10):1109–17.
44. Perez RO. Complete clinical response in rectal cancer: a turning tide. Lancet Oncol. 2016;17(2):125–6.
45. Maas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, etal. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010;11(9):835–44.
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Optimizing Function forVery Low Rectal Tumors: Intersphincteric Resection
27
orAPR?
SrikanthParsi, JeanSalem, andJohnH.Marks

Introduction

Rectal cancer is a challenging entity posing technical problems of operating in the connes of the bony pelvis with proximity to the anal sphincter.
Traditionally rectal cancer was managed by abdominoperineal resection (APR) which was rst described by Miles in 1908 [1]. APR was the only surgical option until Dixon performed anterior resection for upper rectal carcinoma in 1948. It took a while for surgeons to adopt the technique of anterior resection as an alternative to APR as it was associated with signicant morbidity from anastomotic leak and mortality. In 1986, Heald described total mesorectal excision (TME) which dra­matically improved local recurrence rate for rectal carcinoma [2]. The introduction of surgical staples in 1980s allowed ultralow anterior resection for mid-rectal tumors.
However, for low rectal cancers, APR remained the only surgical option until the transanal abdominal transanal (TATA) proctectomy and transanal endoscopic microsurgery (TEM) options emerged in the 1980s [3]. These techniques evolved with the introduction of chemoradiation in the management of rectal carcinoma which revolutionized sphincter-preserving surgery (SPS) for low rectal tumors. As part of a long-standing rectal cancer management program, we were the rst to perform full-thickness local excision (FTLE) after preoperative radiation therapy in 1984 [4].
SPS in the lower pelvis has deterred surgeons because of the challenge of obtaining adequate distal and circumferential margins as well as the difculty in performing a low anastomosis. This is due to the connes of the bony pelvis as well as the tapering
S. Parsi • J. Salem • J.H. Marks (*) Marks Colorectal Surgical Associates, Lankenau Institute for Medical Research, Wynnewood, PA, USA
Division of Colorectal Surgery, Lankenau Medical Center, Wynnewood, PA 19096, USA e-mail: parsis@mlhs.org; salemj@mlhs.org; marksj@mlhs.org
© Springer International Publishing AG 2018 C.M. Schlachta, P. Sylla (eds.), Current Common Dilemmas in Colorectal Surgery,
https://doi.org/10.1007/978-3-319-70117-2_27
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of the mesorectum. Historically, resections in this area have been prone to local recur­rence (LR) and have posed signicant incontinence and poor quality of life.
To address these issues, Gerard Marks in 1984 described the transanal abdominal transanal proctectomy (TATA) with descending coloanal anastomosis for low rectal tumors following high-dose preoperative radiation [5]. The main advantage of TATA is avoidance of a permanent colostomy with preservation of the anal sphincter as this obviates the need for placement of a stapler from above. In the last few years, a modi­cation of TATA emerged in the form of taTME (bottom-up TATA) using single- port laparoscopy to extend the dissection from below. This has even been extended to natural orice transluminal endoscopic surgery (NOTES) where the entire procedure including splenic exure mobilization is performed transanally [6].
S. Parsi et al.
Treatment Strategies forLow Rectal Cancer
Management of low rectal cancer involves a multidisciplinary team and is based on TNM staging of the disease. As part of our multidisciplinary rectal cancer manage­ment program, we offer neoadjuvant chemoradiation therapy for all tumors in the distal third of the rectum and unfavorable cancers at all levels of the rectum (i.e., ≥T3 or N+). The hallmark to extending sphincter preservation and optimizing the benet of the downstaging effect of chemoradiation is that nal decisions regarding surgical treatment are made after completion of the neoadjuvant therapy. TEM can be offered for tumors <4cm in size, <40% of circumference, mobile, and which have regressed to within the rectal wall (≤T2).
For >T2 low rectal tumors, intersphincteric resection (ISR) should be considered along with APR. Sphincter-preserving surgery (SPS) is offered for all patients, except those whose cancer remains xed at or below the 3cm level.
Our standard practice is to wait 8–12weeks and reassess clinically to decide upon the nal surgical plan.

APR Vs Sphincter-Preserving Surgery

Neoadjuvant chemoradiotherapy has led to an increase in the rate of SPS by down­staging the tumor and, coupled with improved surgical technique, a decrease in the locoregional recurrence [7].
In choosing the right procedure in surgical treatment of low rectal carcinoma, one has to take into account several important factors. Patient baseline sphincter function is of course important as are tumor size and involvement of sphincter com­plex, response to neoadjuvant chemoradiation, level of surgeon’s experience in intersphincteric surgery, and lastly patient preference after discussing pros and cons of each procedure. However, it must be emphasized that nal decisions regarding sphincter preservation should be held until the 8–12-week interval to maximize the benet of chemoradiation.
27 Optimizing Function forVery Low Rectal Tumors: Intersphincteric Resection…
Despite this, APR rates in the literature remain as high as 32–67% [8]. We advo­cate that all cancers of the distal 3cm of the rectum that are not xed 8–12weeks after neoadjuvant chemoradiotherapy are managed either by taTME, laparoscopic TATA, ultralow LAR, or TEM.
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Preoperative Planning

Preoperative work-up includes complete blood count, metabolic prole, coagulation prole, liver function test, and baseline carcinoembryonic antigen (CEA). Digital rectal examination (DRE) along with exible sigmoidoscopy and biopsy is per­formed in the ofce during the initial visit. Colonoscopy to rule-out synchronous lesions is performed if not done recently. Tumors are evaluated for extent of invasion by computed tomography (CT), magnetic resonance imaging (MRI), or endorectal ultrasound.
Metastatic disease is evaluated with a CT of the abdomen, pelvis, and chest. Positron-emission tomography CT is not routinely performed unless CT or MRI is equivocal for metastasis.
Patients who undergo neoadjuvant chemoradiation are initially evaluated by DRE and exible endoscopy. Size, xity, position, degree of ulceration, shape, clin­ical T stage, and level in the rectum relative to the anorectal ring are noted originally and at 8–10 weeks post-radiation therapy. At 8–12 weeks after completion of chemoradiation, nal assessment is performed to determine whether ISR or APR is indicated [9]. All patients with adequate sphincter function, except those cancers that remained xed on examination after completion of their neoadjuvant chemora­diation, undergo sphincter-preserving surgery. The TATA is utilized for patients whose cancer resides in the distal 3cm of the rectum.
Every patient undergoing an APR is seen by an ostomy specialist for ostomy teaching. A very high level of preoperative education and expectation from either surgery are discussed in detail prior to surgery.

TATA Procedure

This operation is offered to patients with non-xed cancers in the distal 3cm of the rectum. Patients are positioned in extreme lithotomy position with Yellons® Stirrups (Allen Medical Systems, Acton, MA) for adequate perianal exposure (Fig.27.1). It is therefore essential that patients are secured rmly to the operating table. Preoperative antibiotic is given along with alvimopan for faster gastrointesti­nal recovery in the postoperative period. The abdomen and anus are prepped with povidone-iodine and drapes secured to the anus with 2-0 nylon suture. We use lighted suction device that is very helpful during the procedure (VitalVue™, Medtronic Minimally Invasive Therapies, New Haven, CT).
To start, the perineum is injected with lidocaine and epinephrine for hemostasis and to facilitate dissection.
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Fig. 27.1 Patient positioning and operating room setup
S. Parsi et al.
Allis-Adair clamps are used to evert the anal canal and to identify the dentate line (Fig.27.2). The hallmark of the TATA is starting the operation transanally by per­forming a full-thickness circumferential incision at or just above the dentate line, followed by an intersphincteric dissection (Fig.27.3). The dissection is carried out in the intersphincteric plane between the puborectalis and the internal sphincter circumferentially (Fig.27.4). The TATA is classically performed by making an inci­sion at the dentate line, therefore excising the upper half of the internal sphincter, while preserving the external sphincter, puborectalis, and levator ani. When the tumor invades the upper anal canal, at times a complete resection of the internal sphincter is carried out, but the functional outcome is likely impaired in this situa­tion. The rectum is mobilized transanally to the level of the cervix in female subjects and the seminal vesicles in male subjects. This allows for a known distal margin while sparing the external sphincter and the distal half of the internal sphincter muscles. The rectum is then oversewn in a watertight fashion followed by place­ment of a transanal access platform (GelPOINT Path, Applied Medical, Rancho Santa Margarita, CA) and a exible-tip Olympus videoscope (Fig.27.5). Driving the camera is a signicant challenge because of the infrequent use of exible-tip cameras and the constant need to avoid collision with the surgeon instruments in a narrow working space. We continue the dissection with the help of a LigaSure™ (Medtronic Minimally Invasive Therapies, New Haven, CT) bipolar energy device, transanally as proximal as possible, including opening the peritoneal cavity, mobi­lization of the left colon and the splenic exure, and ligation of the inferior mesen­teric artery and vein, when possible.
27 Optimizing Function forVery Low Rectal Tumors: Intersphincteric Resection…
Fig. 27.2 Allis-Adair clamps are used to evert the anal canal and identify the dentate line. Dissection is started by doing a full-thickness circumferential incision at the dentate line
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Fig. 27.3 Intersphincteric dissection carried circumferentially
The abdominal dissection is completed by open, laparoscopic, or robotic tech­niques. In our early experience, the abdominal portion was completed in an open fashion. Over the last decade, we began using minimally invasive transanal and transabdominal platforms for the completion of the dissection. The abdominal por­tion is completed laparoscopically either with a single-port or multiport technique. The rectum and sigmoid colon are then delivered transanally and transected at the sigmoid-colic junction (Fig.27.6). A hand-sewn coloanal anastomosis is performed
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Fig. 27.4 Intersphincteric dissection landmarks: dissection carried out in the intersphincteric plane between the puborectalis and the internal sphincter. The upper portion of the internal sphinc­ter is resected en bloc with the rectal specimen
S. Parsi et al.
Fig. 27.5 Placement of a transanal access platform
transanally with 0 Vicryl sutures (Ethicon. Cincinnati, OH). Different options of anastomosis exist: straight coloanal, colonic J-pouch-anal, side-to-end anastomosis. A temporary diverting stoma is made to protect the coloanal anastomosis. In case of SILS abdominal approach, we use the same site for the diverting ileostomy in the right lower abdomen [10].
27 Optimizing Function forVery Low Rectal Tumors: Intersphincteric Resection…
Fig. 27.6 Delivery of the specimen transanally
307

Complications

Early complications pertaining to TATA include anastomotic dehiscence/leak (5–48%), pelvic abscess (0–9%), intra-abdominal bleeding (0–3.8%), small bowel obstruction (0–16%), and internal hernia [11, 12]. Delayed complications include anastomotic stricture (2% to 16%) and neorectal prolapse (0.8–3.7%) [12].

Postoperative Management

Postoperatively, intravenous doxycycline is provided while the patient is hospital­ized; this is continued orally for 10days after discharge for all patients. Our postop­erative pain regime includes IV ketorolac and intramuscular meperidine. Very rarely, patients need patient-controlled analgesia (PCA). A clear liquid diet is initi­ated immediately postoperatively. Patients are assessed at follow-up at 2weeks after surgery, every 3months for the rst 2years, every 4 months for the next 2years, every 6months for the fth year, and yearly thereafter.
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S. Parsi et al.
Clinical and digital examinations are performed at each postoperative visit. Flexible sigmoidoscopy is performed at 6-month intervals for the rst 2years. Full colonoscopy is performed at 1year followed by every 3years. CEA is measured at each visit, and CT of the abdomen and pelvis is performed at 6months, 1year, and then annually. PET scan is performed selectively if recurrence is suspected.

Results

Between 1984 and 2015, we have performed 373 TATA procedures. The mean tumor level from the anorectal ring was 1.7cm. About 97.7% of patients received neoadjuvant radiation with a mean dose of 5405 cGy. Seventy-seven percent of patients received concurrent chemotherapy with infusional 5FU or capecitabine. Mean time from completion of neoadjuvant therapy was 11weeks.
The TME was initiated transanally in all cases with the abdominal portion com­pleted in an open fashion in 48% (n = 180) and laparoscopic approach in 52% (n=193) of cases. Of patients who underwent laparoscopic surgery, the abdominal portion was carried out by multiport access in 147 patients, SILS in 34 patients, and robotic access in 13 patients. In 38 patients, the transanal TME dissection was con­tinued further using a single-port platform into the peritoneal cavity as in the taTME fashion. A hand-sewn coloanal anastomosis was performed via a colonic J-pouch, side-to-end , or straight coloanal anastomosis depending on the length of the remain­ing colon. A temporary diverting loop stoma was made in all patients. Overall mean blood loss was 550mL and incidence of transfusion was 12.6%. Mean length of stay was 6.2days.
In regard to complications, there was one perioperative mortality due to myocar­dial infarction (0.3%).
The overall morbidity rate was 25.7%. Early morbidity was 13.4% with 4 anas­tomotic dehiscences, 3 pelvic abscesses, and 3 small bowel obstructions. Reoperation was performed in two patients, one for internal hernia and the other for intra­abdominal bleeding. Delayed morbidity rate was 12.3% with 10 pelvic abscesses, 10 anastomotic strictures, and 10 patients with neorectal prolapse.
Overall 25.3% had complete pathological response. Tumor’s nal pathological stages were as follows: 9.6% were ypT1, 33.1% ypT2, 31.7% ypT3, and 0.34% ypT4. About 4.8% had positive circumferential resection margin of <1mm.
Mean follow-up was 65.7 months. The overall 5-year survival was 90% (KM5YAS) and was better in patients who underwent a laparoscopic abdominal completion of transanally initiated TME rather than open abdominal approach (93 vs 87%, p=0.03). Overall local recurrence rate was 7.4%. LR was also less in lapa­roscopic group when compared to open group (4.3 vs 10.85%, p=0.02).
Distance metastasis was observed in 19.5%. Only four patients required salvage APR.
27 Optimizing Function forVery Low Rectal Tumors: Intersphincteric Resection…
309

Functional Outcomes: ISR Vs APR

Surgical resection represents the mainstay treatment of rectal cancer. However, for patients with very low rectal cancer, this usually entails removing the anal sphincter and committing the patient to a permanent colostomy. Although APR offers the chance of cure, it is correlated with a worse quality of life (QoL) and an increased prevalence of depression because of the permanent colostomy [12].
Around one-quarter of stoma patients experience clinically signicant psycho­logical symptoms postoperatively. The most common symptoms are those of an anxiety disorder and major depressive episode. Twenty-nine percent of the patients improve psychologically after surgery, 23% deteriorate, and 48% of patients experi­ence no change in psychological symptoms [13].
Studies suggest that patients with a stoma have also a poorer QoL than those without a stoma, and although many patients accept a colostomy without issue, many patients consider life with a permanent colostomy to be unacceptable [14, 15]. Stoma patients seem to report similar concerns. These can be broadly categorized into concerns about changed body image and attractiveness, noise, odor, and leak­age. To tackle these psychological and QoL issues, we were the rst to describe the TATA proctosigmoidectomy, a sphincter-preserving surgery designed to simultane­ously cure the rectal cancer and avoid a permanent colostomy [16]. Although this approach has been well described, for a variety of reasons, its adoption in the surgi­cal community has been limited. A major concern voiced has been, ironically, con­cerns over the QoL of patients in terms of continence and functional status. Indeed, a common refrain from many surgeons reluctant to the approach of expanded sphincter preservation has been either “The patient would be better off with a colos­tomy” or “Why give the patient a perineal colostomy?”.
To address these concerns, we have recently published our data on QoL after TATA [17]. It is one of the largest studies in the literature with 90 patients included, and it adds signicantly to the understanding of QoL of patients in the United States after ISR and TATA.Patients were surveyed using the FIQLS, EORTC QLQ-C30, CR38, and the Marks Metric for Effect of Continence on QoL.We concluded that patient’s QoL was not signicantly different after surgery. However, in subgroup analysis, we found that patients with more proximal tumors had better lifestyle and physical and emotional scores and that older patients performed better on multiple levels; this is perhaps related to the fact that older patients coped better and had more realistic expectations than younger ones [8]. When we compared our results with those published in the literature for APR using standardized questionnaires, patients who underwent TATA scored better in all of the functional scales, including general QoL, physical, role, emotional, cognitive, and social [17].
Konanz etal. compared the QoL of patients after low anterior resection, ISR, and APR using the EORTC QLQ-C30, CR38, and the Wexner score [18]. They found that global QoL was comparable between the groups. However, physical and sexual functions were signicantly better after ISR compared with APR, but diarrhea and constipation were higher after ISR [18].