The American Journal of Surgery (2014) -, -–-

Transanal minimally invasive surgery for benign and malignant rectal neoplasia Elisabeth C. McLemore, M.D., F.A.C.S., F.A.S.C.R.S.a,*, Lynn A. Weston, M.D.b, Alisa M. Coker, M.D.a, Garth R. Jacobsen, M.D.a, Mark A. Talamini, M.D.a, Santiago Horgan, M.D.a, Sonia L. Ramamoorthy, M.D.a a

Department of Surgery, University of California, San Diego, CA, USA; bDepartment of Surgery, Scripps Health Systems, San Diego, CA, USA

KEYWORDS: Transanal minimally invasive surgery; Transanal endoscopic microsurgery; Rectal Mass; Endoscope; Rectal cancer; Rectal adenoma; Rectal carcinoid

Abstract BACKGROUND: Transanal minimally invasive surgery (TAMIS), an alternative technique to transanal endoscopic microsurgery, was developed in 2009. Herein, we describe our initial experience using TAMIS for benign and malignant rectal neoplasia. METHODS: This is an institutional review board approved, retrospective case series report. RESULTS: TAMIS was performed in 32 patients for rectal adenoma (13), adenocarcinoma (16), and carcinoid (3). There were 14 women, with mean age 62 6 15 years and body mass index 28 6 5 kg/m2. Lesion size ranged from .5 to 8.5 cm, distance from the dentate line 1 to 11 cm, and circumference of the lesion 10% to 100%. The mean operative time was 123 6 62 minutes. Mean hospital length of stay was 2.5 6 2 days. Complications included urinary tract infection (1), Clostridium difficile diarrhea (1), atrial fibrillation (1), rectal stenosis (1), and rectal bleeding (1). CONCLUSION: TAMIS using a disposable transanal access platform is a safe and effective method to remove rectal lesions in this case series. Published by Elsevier Inc.

Lynn A. Weston and Alisa M. Coker declare no conflicts of interest. Disclosures: Elisabeth C. McLemore, M.D., is a consultant and an instructor for industry-sponsored educational events for Applied Medical and Ethicon Endosurgery. Dr McLemore is a consultant for Covidien. Lynn A. Weston, M.D., has no financial ties to disclose. Alisa M. Coker, M.D., has no financial ties to disclose. Dr Coker is a minimally invasive surgery research resident under the mentorship of Drs Horgan, Talamini, Ramamoorthy, and McLemore. Garth R. Jacobsen, M.D., is a consultant and an instructor for industry-sponsored educational events for Ethicon Endosurgery. Mark A. Talamini, M.D., serves on the advisory board and is a consultant for Olympus. Dr Talamini is also a consultant and an instructor for industrysponsored educational events for Ethicon Endosurgery. Educational grants from Ethicon Endosurgery and Olympus provide additional funding to support research, education, and training conducted at the UC San Diego Center for the Future of Surgery. Santiago Horgan, M.D., serves on the advisory board and is a consultant for Olympus. Dr Horgan is also a consultant and an instructor for industrysponsored educational events for Ethicon Endosurgery. Educational grants from Ethicon Endosurgery and Olympus provide additional funding to support research, education, and training conducted at the UC San Diego Center for the Future of Surgery. Sonia L. Ramamoorthy, M.D., is a consultant and an instructor for industry-sponsored educational events for Applied Medical and Ethicon Endosurgery. * Corresponding author. Tel.: 11-858-822-6173; fax: 11-858-228-1759. E-mail address: [email protected] Manuscript received May 31, 2013; revised manuscript December 27, 2013

0002-9610/$ - see front matter Published by Elsevier Inc. http://dx.doi.org/10.1016/j.amjsurg.2014.01.006

The American Journal of Surgery, Vol -, No -, - 2014

2 Table 1

Transanal excision versus transanal endoscopic microsurgery3–6

Lesion characteristics and restrictions

Surgical equipment

Equipment capabilities

Transanal excision

Transanal endoscopic microsurgery

,8–10 cm from anal verge ,3–4 cm in size ,40% circumference Anal retractor/anoscope Standard open instruments

4–25 cm from anal verge Any size Any circumference Proctoscope Operating instruments Setereoscope Insufflators/suction device 4 ports of access Light source/camera Suction/insufflation

Anal retraction

There has been a significant evolution of the transanal excision technique over the past 30 years. In 1983, Gerhard Buess1,2 introduced a disruptive technique in colorectal surgerydtransanal endoscopic microsurgery (TEM). The initial results comparing TEM with the standard of care, transanal excision (TAE), revealed that TEM was associated with a superior quality of resection demonstrated by the higher rate of achieving negative margins (90% TEM vs 71% TAE) (Table 1).3–6 Longer term data revealed that TEM resection of rectal lesions also resulted in a lower local recurrence rate compared with the standard of care, TAE (5% TEM vs 27% TAE). TEM is one of the 1st colorectal surgical techniques with immediate operative outcomes that have surpassed the bar of noninferiority, thereby achieving superior results compared with the standard of care, TAE.7–10 The improved clinical outcomes with TEM resection are likely because of the significant improvement in visibility with TEM compared with TAE. The magnified view and stereoscopic optics allow for precise margin outline, dissection, and defect closure.4 The reported rate of conversion to open surgery is 1% and complication rates range from 4% to 28%.4711–13 In addition to improved clinical outcomes, the TEM technique allows for endoluminal removal of more proximal lesions and larger lesions when compared with TAE (Fig. 1). Despite the technical advantages and improved outcomes with TEM, TAE remains the most common

Figure 1

procedure for local resection of rectal tumors in the United States.4 The lag in adoption of TEM in the United States is likely secondary to the steep learning curve for TEM, confounded by its introduction at a time in surgery that preceded the surge of laparoscopy and minimally invasive surgical interest and skill set acquisition. In addition, the purchase of the TEM equipment requires a sizable capital investment, which can be a difficult hurdle to overcome when the projected case volume may be unknown. As we have gained experience and confidence with minimally invasive and single incision surgery, the learning curve for TEM has become less of an obstacle to adopting this technique. However, hurdles that have continued to limit the adoption of TEM include narrow working space within the long, rigid working proctoscopes, tumor location dependent patient positioning, capital investment for the TEM equipment, and operative equipment set up time. There are currently 2 platforms available to perform transanal endoscopic surgery using a rigid proctoscope (Table 2, Fig. 1; TEM: Richard Wolf Medical Instruments Corporation, Vernon Hills, IL; transanal endoscopic operation [TEO]: Karl Storz GmbH & Co, Tuttlingen, Germany). In 2009, Atallah et al14 nicely demonstrated an innovative use of an single incision laparoscopic surgery (SILS) port for transanal access to perform excision of rectal lesions as a feasible alternative to TEM. The new technique,

Evolution of transanal endoluminal surgical excision of rectal lesions.

No longer available in United States (single use) No Yes

Ethicon Endosurgery

$500.00 (single use) $800.00 (single use) $800.00 (single use) Covidien Applied Medical Applied Medical No No Yes Yes Yes Yes 4 5 15

SILS GelPOINT Path GelPOINT Path Long Channel SSL

8–10 8–10 15

$30,000 Karl Storz Endoskope Yes Yes 7.5, 15, and 20 TEO

7.5–15

$80,000 Richard Wolf Yes Yes

Transanal endoscopic microsurgery (TEM) Transanal endoscopic operation (TEO) Transanal minimally invasive surgery (TAMIS)

15 and 20

15–20

N/A N/A No Yes 8–10 3–5

Anoscope, rectal retractors TEM Transanal excision (TAE)

Platform length (cm) Platform

Proximal reach (cm)

TAMIS for rectal masses

Technique (acronym)

Table 2

Transanal access devices for endoluminal resection of rectal lesions

Transanal access

Intraluminal rectal cretraction

Company

Approximate cost (single use)

E.C. McLemore et al.

3 TransAnal Minimally Invasive Surgery (TAMIS), has gained global interest and widespread adoption of the technique into clinical practice.15–30 New terminology such as soft, disposable transanal access platforms to generically describe the commercially available transanal access devices and rigid proctoscope platforms has emerged in an attempt to generically describe the commercially available transanal endoluminal surgery platforms. This has further increased the number of acronyms and confusion associated with the variety of surgical techniques and platforms available to perform transanal endoluminal surgical resection of rectal lesions (Table 2). Despite the advantages of TAMIS, there are limitations of TAMIS compared with TEM and TEO. Disposable transanal access platforms are just that, transanal access platforms. The longer channels associated with the TEM and TEO equipment facilitate intraluminal rectal retraction as well as transanal access for removal of rectal lesions. Rectal lesions located behind a rectal haustral valve may be more difficult to access and remove when using a TAMIS platform compared with a TEM platform. In addition, the laparoscope used in TAMIS requires a 1st assistant to hold and manipulate the laparoscope during the TAMIS procedure. Finally, the proximal reach of a disposable transanal access device varies considerably and is dependent on patient anatomy and mobility of the proximal rectal lesion (Table 2). A disposable longchannel device is now commercially available, but lacks the external fixation that is available with the TEM and TEO equipment (Table 2). Many surgeons who have been performing TEM for several years query, ‘‘Is TAMIS the same as TEM?’’ The answer remains undetermined at this time in the early phase of evaluation of TAMIS. Therefore, surgeons performing TAMIS are encouraged to evaluate and report their preliminary results with TAMIS including margin status, specimen fragmentation, and complications associated with the technique in a similar fashion to the preliminary phase of TEM evaluation. At this time, the evaluation of the TAMIS technique is in its infancy and the follow-up time period is too short to present meaningful long-term results such as local recurrence and survivorship. Currently, case reports and small case series are the only publications in the literature evaluating short-term outcomes of the TAMIS technique (Table 3). The purpose of this article is to evaluate the short-term outcomes of the TAMIS technique used to remove benign and malignant rectal neoplasia.

Methods This is an institutional review board approved, retrospective case series report. All transanal endoluminal surgical resections of rectal neoplasia using the TAMIS technique over a 2-year period (June 2011 to May 2013) were reviewed and included in this case series. Patient

4

Table 3

TAMIS case reports and series report publications

Author Year

N

Platform

Location from anal verge (cm)

Size (cm)

OR time (min)

Margin status

Atallah et al 201014

6

SILS

9.3 (6–13)

2.93 (.6–6)

86 (43–192)

1 Positive

Khoo 201017 Lorenz et al 201018

1 3

SILS SILS

10 6–8

6 Unknown

Unknown Unknown

Negative Negative

12

SILS (2 converted to TAE)

7 (3–20)

3.5 (2.5–5)

55 (40–80)

Negative

Lorenz et al 201220

13

5–8

Unknown

Unknown

Unknown

Barendse et al 201221

15

SILS Triport SSLA (2 converted to TEM)

6 (0–14)

3.6 (1–9)

57

Negative

Lim et al 201222

16

SILS

6.8 (4–10)

.8 (.6–1.5)

90.3 (33–160)

Negative

eTAMIS GelPOINT Path SSL (1 converted to LAR)

8 4 (1–6)

2.2 Unknown

101 52 (38–72)

Negative Negative

McLemore et al 201223 Seva-Periera et al 201324

1 5

T.G. Lee and S.J. Lee 201325

25

SILS

9 (6–17)

2.3 (.6–6)

45 (20–120)

Negative

Albert et al 201326

50

GelPOINT Path

8.1 (3–14)

2.8 (.7–6)

75

Positive (3)

Complications None

None None Bleeding (minor, n 5 1) None Bleeding (1)

None

None None

None

3 (6%) Bleeding (1) COPD exacerbation (1) Scrotal emphysema (1)

COPD 5 chronic obstructive pulmonary disease; CRT 5 cathode ray tube; GIST 5 gastrointestinal stromal tumor; LAR 5 low anterior resection; SILS 5 single incision laparoscopic surgery; s/p 5 status post; SSLA 5 single site laparoscopic assisted; TAE 5 transanal excision; TAMIS 5 transanal minimally invasive surgery; TEM 5 transanal endoscopic microsurgery; Tis 5 rectal carcinoma in situ.

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den Boezem et al 201119

Pathology Adenoma (3) Carcinoid (1) Tis rectal cancer (1) T1 rectal cancer (1) Adenoma Adenoma (1) T1 rectal cancer (2) Adenoma (9) T1 rectal cancer (1) T2 rectal cancer (2) Adenoma T1 rectal cancer Adenoma (7) Fibrosis (1) T1 rectal cancer (1) T2 rectal cancer (3) Carcinoid (1) T1 rectal cancer (3) T2/3 s/p CRT (8) Carcinoid (1) Mucocele (1) Tis (Haggit 0) Adenoma (3) Tis rectal cancer (2) T2 rectal cancer (1, LAR) Adenoma (7) T1 rectal cancer (9) Carcinoid (9) GIST (1) Hyperplastic (2) Adenoma (23) Tis rectal cancer (1) T1 rectal cancer (16) T2 rectal cancer (3) T3 rectal cancer (3) Carcinoid (2)

E.C. McLemore et al.

TAMIS for rectal masses

demographics, perioperative data, pathology, interval surveillance, and follow-up variables were recorded. The rectal neoplasia was discovered during screening or diagnostic lower endoscopy in all cases. Before TAMIS, all patients with lesions R3 cm or high grade dysplasia undergo preoperative clinical staging for rectal cancer as the lesion is assumed to be a malignancy until proven otherwise. Clinical staging includes endoscopic biopsy, complete colonoscopy (if not already performed), endoscopic ultrasound, computed tomography of the chest, abdomen, pelvis, and carcinoembryonic antigen. A rigid proctoscopy is also performed to confirm lesion location, size, and distance from the anal verge. All patients undergo a standard polyethylene glycol bowel preparation the day before surgery. Under general endotracheal anesthesia, the patient is placed in either the lithotomy or prone split-leg position. The prone split-leg position is our preferred position for low-lying anterior lesions. The TAMIS technique is performed using either the GelPOINT Path, GelPOINT Path Long Channel (Applied Medical, Rancho Santa Margarita, CA), or SILS port (Covidien, Mansfield, MA) for transanal access (Table 2). Visualization is achieved using either a bariatric length 30 or 40 5-mm laparoscope (Stryker, Kalamazoo, MI; Fig. 2). As pioneers in minimally invasive surgery and NOTES,31 we have become comfortable with employing the endoscope for visualization during TAMIS and frequently used a single-channel standard colonoscope for visualization instead of a standard laparoscope (Colonoscope CF-140L; Olympus America, Inc, Center Valley, PA; Fig. 1).23 Either three 10-mm ports or two 10-mm ports and the endoscope are passed directly through the gel matrix in a triangular orientation. The gel matrix cap is then secured to the soft, disposable, anal retractor (Fig. 2). A pneumo-rectum is established with warm carbon dioxide at the lowest pressure necessary to achieve adequate visualization (range 5 to 25 mm Hg). In the majority of cases,

5 the GelPOINT Path disposable, transanal access platform is sufficient for transanal access and removal of lesions up to 8 to 10 cm from the anal verge. If the lesion is not adequately visualized because of the proximal location of the lesion and/ or visual obstruction secondary to rectal transverse folds (Houston valves), the GelPOINT Path Long Channel is used instead and the disposable platform is placed into the anal canal with the introducer in place to approximately 4-cm distance from the anal verge. The introducer is removed. The gel matrix cap is then secured to the disposable, long-channel platform. A pneumo-rectum is re-established with warm carbon dioxide at the lowest pressure necessary for adequate visualization. The long channel is then advanced under direct vision and navigation around the transverse rectal folds up to the level of the tumor location. The GelPOINT Path Long Channel can reach lesions up to 15 cm from the anal verge. A SILS port is used in patients with narrow or fibrotic anal canals that do not allow for placement of the GelPOINT Path transanal access device. After the lesion is identified, a 1-cm circumferential margin is marked using standard electrocautery. Either a full thickness or a submucosal excision is then performed with the use of an ultrasonic energy device. The specimen is removed, oriented, and sutured to a needle board for pathologic examination. The disposable transanal access device is then replaced and the intraluminal pressure is reduced slightly (reduced by 2 to 5 mm Hg) to facilitate closure of the resulting defect. The defect is closed with the use of a suture and knot tying assist devices. The pneumorectum is decompressed, the disposable transanal access platform is removed, and the patient is extubated and transferred to the postoperative recovery area. The patient is allowed to eat a regular diet immediately postoperatively and monitored for 24 hours in a hospital setting before being discharged to home. Laparoscopic assistance and visualization as an adjunct to TAMIS was performed in 3 higher risk cases for intraperitoneal entry with full-thickness excision. Standard

Figure 2 TAMIS using laparoscopic and endoscopic visualization. Visualization is achieved using either a bariatric length 30 or 40 5-mm laparoscope (A) or a single-channel standard colonoscope (B).

The American Journal of Surgery, Vol -, No -, - 2014

6 Table 4 Age/Sex

Rectal adenoma and low-grade carcinoid tumor characteristics Tumor* location (cm)

Rectal adenoma 53/F 3 54/M 5 34/M 1 50/Fx 10 53/Fx,k

11

Tumor position

Tumor diameter (cm)

Preoperative diagnosis

Final tumor pathology

Anterior Posterior Anterior Anterior

7.5 3.9 4 2.2

Adenoma uT1N0 Adenoma† Adenoma

Negative Negative Negative Negative

Posterior

3

Adenoma

6.8

Adenoma

Sessile adenoma with HGD Villous adenoma NRD‡ Tis rectal ca Haggitt Level 030 Tubulovillous adenoma with HGD Tubulovillous adenoma

8.5

Adenoma

Negative

3.5 1.9 4

Adenoma Adenoma Adenoma

2.9 3.6 4.3

Adenoma Adenoma Adenoma

Tubulovillous adenoma with extensive HGD Tubulovillous adenoma Tubular adenoma{ Tubulovillous adenoma with extensive HGD Tubulovillous adenoma Villous adenoma Villous adenoma

58/Fx

6

51/Fx,k

3

Posterior Left lateral Circumferential

56/Mx 51/Fx 81/Mx

6 10 3

Left posterior Left anterior Left posterior

71/Mx 7 Left lateral 87/Mx 1 Posterior 70/Mx,k 3 Left anterior Rectal low-grade carcinoid neuroendocrine tumor 71/M 3 Right lateral

.5

Carcinoid tumor

40/M

4

Anterior

.6

Carcinoid tumor

42/M

7

Anterior

.7

Carcinoid tumor#

Carcinoid tumor Grade 1, pT1a Carcinoid tumor Grade 2, pT1a NRD

Margin

Negative Negative

Negative Negative Negative Negative Negative Negative Negative Negative Negative

Tumor diameter is the maximal measured ex vivo lesion size and is measured by a pathologist. x # { k F 5 female; HGD 5 high-grade dysplasia; M 5 male; NRD 5 no residual disease; pT 5 pathologic tumor thickness ‘‘T’’ status; TAMIS 5 transanal minimally invasive surgery; Tis 5 rectal carcinoma in situ. *Proximal distance in centimeter from dentate line. † Local excision at outside institution referred for local re-excision. ‡ No residual disease. x Denotes eTAMIS (endoscopic visualization instead of laparoscopic visualization). k Denotes TAMIS assisted with laparoscopic visualization. { Endoscopic mucosal resection with positive margins. # Submucosal dissection and excision (not full-thickness excision). , , ,

laparoscopic ports and instrumentation were used. In these cases, a pneumoperitoneum is established 1st using left subcostal Veress needle insufflation with warm carbon dioxide. A 5-mm laparoscopic port is placed in the supraumbilical position under direct visualization. One to 2 additional abdominal 5-mm ports are placed for retraction or suction and irrigation as needed for TAMIS defect closure air leak test. The disposable transanal access platform is then deployed and the endoscopic surgical resection is performed as described above.

Results TAMIS was performed in 32 patients for rectal adenoma (n 5 13), adenocarcinoma (n 5 16), and carcinoid neuroendocrine tumor (n 5 3). There were 14 female and 18 male patients (Tables 4 and 5). The mean age was 62 6 15 years and mean body mass index 28 6 5 kg/m2. The modal

American Society of Anesthesiologists physical status classification preoperative assessment score was 3 6 1 (range 1 to 4). The mean rectal lesion size was 3 6 2 cm (median 4 cm, range .5 to 8.5 cm), distance from the dentate line ranged from 1 to 11 cm (mean 4 6 3 cm), and the endoluminal circumference of the lesion ranged from 10% to 100% (mean 28% 620%). The mean operative time was 123 6 62 minutes (median 115 minutes, range 55 to 362 minutes). Twenty-one cases were performed with endoscopic visualization.23 The other 11 cases were performed with a bariatric length 30 or 40 5-mm laparoscope. Three higher risk cases for peritoneal entry or postoperative leak were performed with transabdominal laparoscopic visualization to perform a leak test after TAMIS endoluminal defect closure. The majority of TAMIS cases (n 5 29) were performed using a full-thickness excision technique. Two cases with rectal adenomas were performed with submucosal dissection to minimize risk of peritoneal entry (lesion locations anterior and proximal to 10 cm).

Age/Sex

Rectal invasive adenocarcinoma tumor characteristics Tumor* location (cm)

Tumor diameter (cm)

Preoperative diagnosis

Final tumor pathology

Margin

2.4 4

uT3N0† uT1N0

NRD‡ Rectal cancer pT2N0 moderate differentiation, low grade, negative LVI/MSI, 0/3 LN negativex NRD‡ Rectal cancer pT1Nx moderate differentiation, low grade, negative LVI/MSIx Rectal cancer pT2Nx moderate differentiation, low grade, negative LVI/MSIx 1.4-cm focus of invasive rectal cancer pT1N0, well differentiated, low grade, negative LVI/MSI NRD‡ NRD‡ Rectal cancer pT1N0 moderate differentiation, low grade, negative LVI/MSIx Tubulovillous adenoma with extensive highgrade dysplasia, no residual rectal cancer NRD‡ Rectal cancer pT2Nx well differentiated, low grade, negative LVI/MSI Rectal cancer pT2Nx radiation effect, deep margin positive NRD‡, 4 LN negative

Negative Negative

54/M 69/M

1 2

Anterior Anterior

60/F 83/M

6 3

Right lateral Posterior

93/F

2

Posterior

3

uT2N0

59/F{

4

Anterior

5

uT1N0

78/F{ 50/F{ 50/M{

5 2 11

Anterior Posterior Anterior

1.6 1.2 4.1

Rectal cancer# uT0N0 after EMR Rectal cancer# uT0N0 after EMR uT1N0

57/M{

2

Posterior

5

61/F{ 83/M{

5 3

Left anterior Posterior

2.3 .9

Focus of invasive adenocarcinoma (.5 and .2 cm) after EMR Rectal cancerk,#uT0N0 after EMR Adenoma uT2N0

91/M

1

Anterior

4

57/M{

7

Left posterior

3.7

50/M{

3

Right anterior

3.5

77/ F{

3

Posterior

3

.5 .9

uT1N0k Adenoma uT0N0

uT2N0 no plane between rectum and prostate Rectal cancerk,# uT0N0 after EMR uT1N0 Rectal cancerk,# uT0N0 after EMR

Rectal cancer pT1Nx moderate differentiation, low grade, negative LVI/MSIx NRD‡

Negative Negative Negative Negative

TAMIS for rectal masses

Tumor position

E.C. McLemore et al.

Table 5

Negative Negative Negative Negative Negative Negative Positive Negative Negative Negative

Tumor diameter is the maximal measured ex vivo lesion size and is measured by a pathologist. EMR 5 Endoscopic mucosal resection; F 5 female; LN 5 lymph nodes; LVI 5 lymphovascular invasion; M 5 male; NRD 5 no residual disease; pTxNx 5 pathologic tumor thickness ‘‘T’’ and lymph node ‘‘N’’ status; TAMIS 5 transanal minimally invasive surgery; TES 5 transanal endoscopic surgery; uTxNx 5 preoperative endoscopic ultrasound clinical staging. *Distance in centimeter from dentate line. † Patient declined standard resection, palliative TES local excision after combined modality therapy. ‡ No residual disease. x Patient declined standard resection, palliative TES local excision only, declined postoperative combined modality therapy. k Endoscopic mucosal resection with positive margins. { Denotes eTAMIS (endoscopic visualization instead of laparoscopic visualization). # Endoscopic mucosal resection with findings of T1-invasive adenocarcinoma.

7

8

The American Journal of Surgery, Vol -, No -, - 2014

The majority of cases were performed in the lithotomy position (n 5 25). The procedure was performed in the prone position in cases where the lesion was a low-lying anterior lesion. All cases with one exception were performed using the GelPOINT Path or GelPOINT Path Long Channel (Applied Medical Table 2). In this case, the lower rectum and anal canal were fibrotic and mildly stenotic secondary to soft tissue damage from external beam radiation therapy for prostate cancer and we were unable to deploy the GelPOINT Path transanal access platform. In this case, the patient had a T2 anterior rectal cancer and TAMIS was offered as a palliative surgical option as the patient was advanced in age and declined radical surgical management. The SILS port (Covidien; Table 2)14 was placed instead with inability to achieve full-thickness resection without potential injury to the underlying prostatic urethra. The TAMIS procedure was aborted and standard TAE technique was attempted, which was unsuccessful because of poor visualization in this case leaving residual disease behind. The margins were knowingly positive in this case and this case was the only case with positive margins in this series. The final pathology was adenoma in 10 cases, rectal carcinoma in situ in 1 case (Tis, Haggitt32 Level 0), T1-invasive adenocarcinoma of the rectum in 6 cases, T2-invasive adenocarcinoma of the rectum in 4 cases, low-grade carcinoid tumor in 2 cases, and no residual disease was found in 9 cases (Tables 4 and 5). In one case, the preoperative clinical staging revealed a T1 rectal lesion on endoscopic ultrasound (uT1N0) with adenoma and high-grade dysplasia findings from the endoscopic biopsy; however, the final pathology did not reveal any invasive adenocarcinoma (Table 4). Conversely, in one case, the preoperative clinical staging revealed no evidence of mucosal invasion on endoscopic ultrasound (uT0N0) and adenoma findings from the endoscopic biopsy; however, the final pathology did reveal a T1invasive adenocarcinoma of the rectum (Table 5). In all 6 cases of T1-invasive adenocarcinoma of the rectum, the neoplasms were well to moderately differentiated (low grade), without evidence of lymphovascular invasion or microsatellite instability, and the lesion size was 4 cm or less. In all 4 cases of T2-invasive adenocarcinoma of the rectum, radical salvage proctectomy with total mesorectal excision was recommended as the standard of care. However, in all 4 cases, despite being well informed regarding the risks of inoperability if local recurrence or metastatic disease develops in the future, the patients have elected to decline further therapy including adjuvant chemotherapy or chemoradiation therapy secondary to personal preference and/or associated severe medical comorbidities. The mean hospital length of stay was 2.5 6 2 days (median 2, range 1 to 10 days). Fifteen patients were discharged home within 24 hours (47%). The overall morbidity rate was 25% (n 5 8). There were no mortalities. Complications included urinary tract infection

(UTI, n 5 1, adenoma), Clostridium difficile diarrhea (n 5 1, adenoma), atrial fibrillation and extraperitoneal dehiscence (n 5 1, invasive adenocarcinoma), rectal stenosis (n 5 1, circumferential adenoma), transient fecal incontinence (n 5 3; 1 adenoma, 2 invasive adenocarcinoma), and hospital readmission for rectal bleeding (n 5 1, adenoma). The UTI occurred in a patient with urinary retention requiring foley catheter replacement. The C. difficile diarrhea was detected during the follow-up period in a patient with persistent diarrhea and was successfully managed with oral antibiotic therapy as an outpatient. The extraperitoneal dehiscence was successfully managed with bowel rest, total parenteral nutrition, intravenous antibiotics, and close clinical monitoring with resolution of the atrial fibrillation within 24 hours in an elderly patient. After 1 week, rectal contrast cross-sectional imaging was performed confirming contained area of dehiscence without tracking of fluid collections or abscess formation. The patient’s oral intake was then resumed and he was discharged home within 3 days (total hospital length of stay 10 days). Rectal stenosis occurred in 1 patient with a large, circumferential adenoma and was discovered at the time of endoscopic surveillance and initially managed with endoscopic dilation. The stenosis recurred after several endoscopic dilations and steroid injections and the patient underwent TAMIS resection of the rectal stricture. Transient fecal incontinence occurred in 1 patient who developed C. difficile diarrhea and 2 elder patients. The incontinence resolved after resolution of C. difficile diarrhea in the 1st patient (2 weeks, adenoma) and approximately 4 weeks in the other 2 cases (invasive adenocarcinoma). Hospital readmission for rectal bleeding was performed in one case for observational purposes as the patient developed a vasovagal response after defecation, the emergency response system was activated, and a significant volume of blood was noted with the bowel movement. The patient’s hemoglobin did not drop lower than 10 g/dL and the patient did not require any blood transfusions or interventions. Urinary retention requiring foley catheter replacement occurred in 6 patients (19%) and was a contributing factor to prolonged hospital length of stay representing 40% of cases with hospital length of stay greater than 24 hours (6 of 17 cases). Urinary retention can be an early sign of pelvic sepsis and is managed conservatively with prolonged observation and further clinical investigation when warranted at this time. The resection margins were grossly and microscopically negative in 100% of cases performed with curative intent. The case in which the TAMIS could not be completed secondary to soft tissue fibrosis and stenosis in the setting of radiation therapy for prostate cancer, thereby leaving residual disease behind, was the only case with positive margins in this series. There has been no evidence of local recurrence detected thus far in this series with short-term endoscopic surveillance and follow-up ranging from 3 to 23 months.

E.C. McLemore et al.

TAMIS for rectal masses

Comments TAMIS using a disposable transanal access device is a safe and effective method to perform local resection of rectal neoplasia. Salvage radical proctectomy with total mesorectal excision is recommended when final pathology reveals RT2 rectal cancer, N1-2, or T1 lesions with highrisk features (size greater than 4 cm, poor differentiation, lymphovascular invasion).33,34 We have successfully achieved a 100% negative margin rate in patients who underwent TAMIS for curative intent. The overall postoperative complication rate was 25% (n 5 8) including UTI, C. difficile diarrhea, rectal bleeding, rectal suture line dehiscence, and rectal stenosis. One TAMIS case resulted in a positive margin in this series in a patient with rectal fibrosis and stenosis secondary to radiation therapy for prostate cancer that subsequently developed a T2 rectal cancer. This patient declined standard radical surgical management of the rectal cancer and TAMIS was offered as a palliative option in this case. We have observed that the pneumatic carbon dioxide insufflation dissects into the surrounding extra-peritoneal pelvic and retroperitoneum soft tissue in cases in which full-thickness resection (whole or in part) is performed. The rate of urinary retention has been observed to occur more frequently in patients who underwent full-thickness resection as did a subjective patient report of pelvic pressure or discomfort after surgery. However, it is difficult to quantify the degree of extraluminal carbon dioxide tissue dissection, therefore precise cause and effect correlation remain unknown at this time. Our current clinical practice is to use foley catheters if urinary retention develops and the addition of oral low-dose metronidazole (250 mg po bid) which seems to have an anti-inflammatory effect and reduces the subjective sensation of pelvic pressure and discomfort. If no clinical improvement occurs with this strategy, the patients are further evaluated with crosssectional imaging with rectal contrast to evaluate for suture line dehiscence, which is managed with bowel rest, parenteral nutrition, and intravenous antibiotics until the pelvic sepsis resolves in stable patients. A flexible sigmoidoscopy is performed 3 months after TAMIS resection to evaluate for stenosis and any evidence of early local recurrence in all cases. The 2012 American Gastroenterology Association screening guidelines for colonoscopy after polypectomy35 are used to guide recommended endoscopic surveillance after the initial flexible sigmoidoscopy for patients with adenomas. All patients with invasive adenocarcinoma of the rectum managed with TAMIS local excision are recommended to enter into a close clinical monitoring surveillance program. In addition to the National Comprehensive Cancer Network36 guidelines, our recommendation is endoscopic and crosssectional imaging with magnetic resonance imaging 3 months after TAMIS, then every 6 months for 2 years, then annually for 3 years to coincide with the survivorship

9 screening program 5-year timeline. There is currently no data available to support this recommendation and we await the results of larger case series and 5-year surveillance program findings and subsequent guidelines. TEM and TEO resection are associated with improved outcomes compared with TAE of rectal lesions. However, TEM and TEO equipment require an initial capital investment and the tumor location dictates patient positioning. An alternative technique, TAMIS, led to the development of a variety of disposable transanal access platforms and has revolutionized global interest in transanal endoluminal surgery. TAMIS resection using a disposable transanal access platform is a safe and effective method to remove rectal neoplasia in this case series. The duration of surveillance and follow-up is short in this case series and longer term follow-up and surveillance will be necessary to determine the longer term local recurrence rate and survivorship.

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Transanal minimally invasive surgery for benign and malignant rectal neoplasia.

Transanal minimally invasive surgery (TAMIS), an alternative technique to transanal endoscopic microsurgery, was developed in 2009. Herein, we describ...
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