Surg Endosc (2015) 29:119–126 DOI 10.1007/s00464-014-3659-7
and Other Interventional Techniques
The evolving practice of hybrid natural orifice transluminal endoscopic surgery (NOTES) for rectal cancer Chien-Chih Chen • Yi-Ling Lai • Jeng-Kae Jiang • Chun-Ho Chu • I-Ping Huang • Wei-Shone Chen • Andy Yi-Ming Cheng • Shung-Haur Yang
Received: 6 February 2014 / Accepted: 23 May 2014 / Published online: 2 July 2014 Ó Springer Science+Business Media New York 2014
Abstract Background Natural orifice transluminal endoscopic surgery (NOTES) has emerged as the area of focus in laparoscopic surgery. Hybrid NOTES (hNOTES) has some potential advantages for treating rectal cancer. Methods Between May 2013 and November 2013, a total of 20 patients (11 males) who received hNOTES at two institutes participating in the study were documented and reviewed. Surgical outcomes, including complications and pathological outcomes, were analyzed. Results The mean age of patients was 57.8 ± 10.1 years (range 34–78). Eleven patients received preoperative neoadjuvant chemoradiotherapy, with the mean distance between tumor and anal verge being 5.9 ± 1.7 cm (mean 2–8). The mean estimated intraoperative blood loss was 68 ± 106 ml (range 30–500), with one case converted to open procedure due to uncontrolled bleeding. Eight cases underwent simultaneous two-team approach. The mean operative time was 200.8 ± 47.7 min (range 110–285). Circular stapling was performed for 14 cases (70 %) as the anastomosis, and protective stoma performed for 17 cases
C.-C. Chen Y.-L. Lai C.-H. Chu I.-P. Huang Department of Surgery, Koo Foundation, Sun Yat-Sen Cancer Center, Taipei, Taiwan C.-C. Chen J.-K. Jiang C.-H. Chu W.-S. Chen S.-H. Yang College of Medicine, National Yang-Ming University, Taipei, Taiwan J.-K. Jiang W.-S. Chen S.-H. Yang (&) Division of Colorectal Surgery, Taipei Veterans General Hospital, No 201, Sec 2, Shih-Pai Rd, Taipei 11217, Taiwan e-mail: [email protected] A. Y.-M. Cheng Boston University School of Medicine, Boston, MA, USA
(85 %). The overall postoperative complication rate was 25 %. Two cases (10 %) develop pelvic abscess due to leakage, which were controlled by medical treatments. The distal and circumferential margins were all free of tumor cells, and the mean distal margin length was 2.4 ± 0.98 cm (range 0.5–4). Conclusions Hybrid NOTES for rectal cancer is safe and feasible. Rapid experience-building accelerates its evolution, as reflected here by the high stapling rate and the idea of a two-team approach. It has the potential to become an option of treating rectal cancers. Keywords Natural orifice transluminal endoscopic surgery (NOTES) Laparoscopic surgery Rectal cancer Transanal TME
Background Natural orifice transluminal endoscopic surgery (NOTES) has emerged as a focused area of laparoscopic surgery. Compared to transvaginal and transgastric approaches, hybrid NOTES (hNOTES) incorporating abdominal and transanal approaches is currently a more suitable route in the field of colorectal surgery [1, 2]. The transanal approach avoids damaging existing non-diseased organs by creating an enterostomy through the diseased organ and incorporating itself into the standard colorectal anastomosis [3]. Potential advantages of transanal approach of NOTES include facilitation of precise dissection in the low pelvic presacral, perirectal, and anterior rectal wall planes [3, 4], obtainment of a sufficient distal margin under direct visualization [5], and avoidance of multiple staples in dividing the rectal stump [3]. Apart from recent literature outlining hNOTES [2, 3, 6, 7], Leroy et al. and Zheng et al.
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have published case reports of pure transanal NOTES (taNOTES) without any abdominal wounds [8, 9]. Prospective randomized trials have already shown that laparoscopic rectal surgery improves short-term postoperative recovery without compromising the safety and completeness of resection compared to open rectal surgery [10, 11]. Laparoscopic rectal surgery is technically demanding, with a conversion rate of 17–29 % [10]. Nonetheless, whether performed via an open or conventional laparoscopic approach, total mesorectal excision (TME) presents difficulties in several conditions such as low-lying lesions, male gender, obesity, and preoperative neoadjuvant therapies. hNOTES might provide another option in navigating these conditions, as it has better visual monitoring and shorter working distance than in the abdominal approach of conventional laparoscopy [12]. In this series, we attempt to analyze our cases, with the first aim to evaluate the safety and feasibility of hNOTES in proctectomy of both low anterior and TME with coloanal anastomosis, and the second to present some new aspects of this rapidly evolving surgery.
Materials and methods Between May 2013 and November 2013, twenty patients with biopsy-proven rectal adenocarcinoma, precancerous lesions, or neuroendocrine tumor receiving hNOTES in Sun-Yat-Sen Cancer Center (led by CCC) or Taipei Veteran’s General Hospital (led by SHY) were documented and reviewed. Patients were cleared from laparoscopic surgery contraindications during preoperative evaluation and were fully informed of the risks and benefits of the hNOTES technique. Each patient provided informed consent, which was then documented into a database approved by each institution’s IRB. Each facility utilized its own surgical team, but had similar principles regarding the transanal approach. All patients underwent initial systemic evaluations before treatment, including physical exam, digital rectal exam, complete colonoscopy, chest X-ray, tumor marker documentation, abdominal ultrasound, and pelvic magnetic resonance imaging or chest and abdominal computed tomography scan. Patients of rectal adenocarcinoma with T3N0 or N (?) received preoperative concurrent chemoradiotherapy (CCRT) as neoadjuvant therapy, while those with pathologically confirmed premalignant lesions or neuroendocrine tumors proceeded directly to surgery. Patients requiring CCRT received one course of radiotherapy delivered by intensity modulated radiation therapy (IMRT) performed at 5,040 Gy in combination with oral form 5-FU upon initial administration of radiotherapy.
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Fig. 1 Operative setting of the equipments and personnels
Radiotherapy proceeded at 4,500 cGy in 25 fractions to the pelvis, followed by 540 cGy in 2 fractions directed at the primary tumor site. Once CCRT was completed, patients were re-evaluated with the same pre-treatment protocols before receiving radical surgery with curative intent 6–8 weeks after completion of CCRT.
Surgical technique and postoperative care The hybrid abdominal and transanal approaches were adopted. Except for minor adaptations made in response to specific patient scenarios, we tried to standardize the procedure step-by-step as detailed below: 1.
2.
Abdominal approach started with a 12 mm trocar inserted through the umbilicus, and a 30-degree-angle rigid videoscope was utilized to visualize the peritoneal cavity. Once the cavity was deemed suitable for laparoscopic surgery, the 12 mm trocar was replaced with a single-incision platform (Gelpoint, Applied Medical, USA), and a 5 mm trocar was placed in the right lower abdominal quadrant. Extra trocars could be added if needed. Abdominal approach aimed to complete ligation of the inferior mesenteric artery and vein, mobilization and division of the sigmoid mesocolon, and division of Toldt’s line. Peritoneal reflection could be opened via abdominal or transanal approach, without rigid regulation.
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Fig. 2 A Made circular division in the posterior rectal wall to gain entrance into the perirectal space. B Opened the peritoneal reflection in the pelvis, transanally. C Closed the rectal stump with purse-string suture, and applied circular stapler
3.
4.
5.
6.
7.
Transanal approach could be started simultaneously with the abdominal approach in a two-team approach, or later after finishing abdominal approach in a oneteam approach (Fig. 1). The adequate distal resection margin was decided first. If it was at the anorectal junction, or further downward in the anal canal, a circular whole layer depth of rectum would be dissected as usual. Then, purse-string suture was done to close the stump. Upward dissection was then accomplished via a multiple port transanal device (GelPOINT Path, Applied Medical, USA) under CO2 insufflation to 9 mmHg. If adequate resection margin could be obtained while sparing 2–3 cm of lower rectum above the anorectal junction, transanal device would then be set up directly. This length of distal rectum was prepared for final circular staple anastomosis. In this way, circular purse-string to occlude the rectal lumen was done first under GelPOINT Path platform, and then the rectum was divided circularly to gain entrance into the perirectal space (Fig. 2A). The purse-string suture could be made by hand-sewing through the anoscope of GelPOINT or by laparoscopic instruments under CO2 insufflation. With access into the presacral avascular plane, the mesorectum was mobilized upward to the promontory region, and the anterior rectal wall was carefully separated from the vagina or prostate to ensure quality of circumferential margins. Dissecting as deeply as possible in the presacral avascular plane is suggested, as this plane is easy to recognize. The peritoneal reflection in the pelvis was reached (Fig. 2B), and the whole rectum was mobilized up to the recto-sigmoid junction, thereby joining the peritoneal cavity and completing the dissection. Due to lack of anatomical landmarks over bilateral sides, dissection along the anterior and posterior aspects first was suggested. Then, the lateral ligaments of both
8.
9.
10.
11.
sides were easier to distinguish from surrounding tissue, and therefore, the hemorrhoid vessels easier to divide. The lesion was subsequently removed either abdominally or transanally, depending on the specimen size and anorectum diameter. Length of the distal rectal stump determined whether a transanal hand-sewn coloanal anastomosis or circular stapler was used to re-establish continuity of the bowel. If the circular stapler was used, the pursestring suture that closed the distal rectal stump was performed transanally. This hand-sewn purse-string suture was performed through the anoscope, with or without CO2 insufflations, depending on the rectal stump length. Purse-string suture was carefully done to ensure full-thickness of rectum encompassed in full circumference. There were two ways of tying purse-strings and performing the circular stapling anastomosis: transanal or abdominal method. The transanal method included tying both purse-strings of the proximal and distal stump onto the shaft of the anvil, as reported by Lacy et al. [13]. The anvil and the spike were connected in the correct position under visualization from the anal side and an end-to-end anastomosis was performed. The other abdominal method differed in tying the purse-string of distal stump directly, without anvil shaft inside. Then, under guidance from abdominal visualization, the instrument spike tip pierced transanally the very tiny slit of the previously tied stump (Fig. 2C). Extending the spike tip to its full length was then helped by the grasper from the abdominal side, and the anastomosis was finished under abdominal guidance as done in conventional laparoscopy. The anastomosis completeness was checked via air inflation test. A 10 mm Jackson-Pratt drain was routinely placed in the pelvis through the right lower abdominal quadrant 5 mm trocar site.
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Table 1 Demographic and preoperative information
Table 2 Operative characteristics
Total number of patients
20
Estimated blood loss (ml)
Male:Female
11(55 %):9(45 %)
68 ± 106 (range 30–500)
Age (years)
57.8 ± 10.1 (range 34–78)
Number of laparoscopic trocarsa
2 ± 0.6 (range 2–4)
ASA grade (I/II/III)
5(25 %)/14 (70 %)/1(5 %)
Two-team approach
BMI (kg/m2)
24.7 ± 3.0 (range 20.7–30.9)
Histology (NECb/Adenocarcinoma/ Benign)
3(15 %)/16(80 %)/1(5 %)
Clinical TNM Stage (I/II/III) Tumor location (cm from anal verge)
4(20 %)/6(30 %)/7(35 %) 5.9 ± 1.7 (range, 2-8)
Two-team
157.5 ± 31.7 (range 110–215)
Neoadjuvant chemoradiation (Yes/No)
11(55 %)/9(45 %)
One-team
CEA Level (ng/ml; normal value B 5)
4.12 ± 3.89 (range 0.80–14.88)
229.6 ± 32.0 (range 190–285)
Previous abdominal surgery (Yes/No)
1(5 %)/19(95 %)
a
a b
ASA American Society of Anesthesiologists NEC Neuroendocrine Carcinoma
12.
Diverting enterostomy or not, either an ileostomy or transverse loop colostomy was decided individually by the operating surgeon.
All patients received postoperative intravenous or epidural pain control, and oral intake began immediately after surgery. Postoperative care and discharge criteria were as outlined by the enhanced recovery program detailed in our previous publication [14].
Statistical analysis Data were analyzed using an SPSS Package (Statistical Product and Service Solutions 16.0 for Macintosh, SPSS Inc., Chicago, IL, USA), and continuous data were expressed as mean ± standard error of the mean. Categorical variables were reported as counts and percentages.
Yes
8 (40 %)
No
12 (60 %)
Operative time (min)
200.8 ± 47.7 (range 110–285)
Anastomosis method Hand-sewn coloanal
6 (30 %)
Circular stapler
14 (70 %)
Splenic flexure mobilization Yes No Diverting enterostomy None
4 (20 %) 16 (80 %) 3 (15 %)
T-loop colostomy
12 (60 %)
Loop Ileostomy
5 (25 %)
Complication Intraoperative complication: bleeding (conversion to open surgeryb) Postoperative complications
6 (30 %) 1 (5 %) 5 (25 %)
Pelvic abscess
2 (10 %)
Urinary retention after
3 (15 %)
Foley removal Hospital stay (days)c
8.85 ± 2.5 (range 6–16)
Readmission after discharged
1 (5 %)
a
15 cases used the single-incision platform as the transabdominal route
b
Reason for conversion: bleeding
c
Postoperative days Reason: fever, status post conservative treatment
d
Results Demographic and preoperative information of 20 patients (11 males) is summarized in Table 1. One patient was ASA grade III, and one other had previous abdominal surgery. Eleven patients (55 %) received preoperative neoadjuvant chemoradiotherapy. Table 2 summarizes operative details. The mean operative blood loss was acceptable. There was a case (5 %) of intraoperative complication. An uncontrolled bleeding during dissection of the presacral plane with an estimated blood loss of 500 ml required conversion to open surgery for adequate hemostasis. There was no bowel perforation during procedures. Two cases needed extra abdominal
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trocars. The mean operative time was 200.8 ± 47.7 min (range 110–285). Two-team approach was applied for eight cases, achieving significantly shorter operative time than that achieved in the one-team approach (P = 0.01). In terms of anastomosis, the hand-sewn method was used in only six cases, while circular stapling was used for the other 14 cases (70 %), all by single stapling method. Four cases needed splenic flexure mobilization to achieve tension-free anastomosis. The only three cases without protective stoma were performed during the later period of this series, and all received circular stapling without leakage in recovery.
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There were 5 cases (25 %) of postoperative complications, including 2 cases of pelvic abscess due to anastomosis leakage, and 3 cases of urinary retention. There was no wound infection. The two cases of pelvic abscess required a prolonged hospital stay (10 and 13 days), with the abscesses subsiding after antibiotic treatment without further radiological or surgical intervention. Three patients had urinary retention after Foley removal and needed recatheterization. The patient with longest duration of urinary catheter retention had a history of prominent prostatism, and the catheter could not be removed until 2 months later. The only one case needing readmission was due to fever three days after discharge. The fever subsided two days later, with no specific origin identified. Table 3 summarizes pathological results. Besides 17 cases of adenocarcinoma, there were 3 cases of neuroendocrine tumors: one carcinoma and two carcinoid with regional lymph node metastasis. Distal margin distance and number of harvested lymph nodes were acceptable; the one case of 0.5 cm margin was that of an adenoma with intramucosal adenocarcinoma (Tis). The distal and circumferential margins were free of tumor cells in all twenty cases; only one case had a circumferential margin distance less than 3 mm, accounting for 7 %. Of the 11 cases that
Table 3 Pathological characteristics Histology Adenocarcinoma
17 (85 %)
Neuroendocrine tumor
3 (15 %)
Differentiation Well
3 (15 %)
Moderately
16 (80 %)
Poorly
1 (5 %)
Maximum tumor diameter (cm)
1.80 ± 1.06 (range, 0.3–3.5)
Lymphovascular Invasion Yes
5 (25 %)
No
15 (75 %)
Distal margin distance (cm)
2.40 ± 0.98 (range, 0.5–4)
Number of retrieved lymph nodes
19.7 ± 6.4 (range, 10–35)
Circumferential margin distancea (mm)
15.2 ± 6.7 (range, 2–20)
\3
1 (7 %)
C3
14 (93 %)
TNM Stage (for adenocarcinoma and adenoma) I 6 (30 %)
a
IIa/IIb
5 (25 %)/1 (5 %)
IIIa/IIIb
3 (15 %)/1 (5 %)
Tis
1 (5 %)
Complete remission
2 (10 %)
Data pertinent to 15 patients
required preoperative CCRT, pathological complete remission was documented in two cases.
Discussion Our series revealed that hNOTES for rectal tumor excision is safe and feasible. Two points reflect the rapidly evolving techniques in this field here: the high percentage of circular stapler application, and the innovation of a two-team approach. One bleeding complication happened during the early period of this series. As surgical experience accumulated quickly, this complication did not happen again when we became familiar with the anatomy viewed via the transanal approach. Five cases (25 %) had postoperative complications. Two cases developing pelvic abscess received protective ileostomy in advance, thereby facilitating resolution under antibiotics without requiring additional radiologic or surgical intervention. Three patients developed urinary retention after Foley catheter removal and required recatheterization. Urinary retention in existing published studies accounted for 6–40 % of postoperative complications [2, 3, 7]. Theoretically, hNOTES has the advantage of preserving autonomic nerve function when compared to conventional laparoscopy. Under better visualization and shorter working distance, hNOTES would lead to less likely over-dissection of Denovillie’s fascia and preserve neurovascular bundles on either side of the prostate than conventional laparoscopy would. However, this issue remains to be further studied. Table 4 summarizes existing literature with case numbers greater than five focusing on hNOTES [2, 3, 5, 7]. The majority of published series begins the transanal approach at the dentate line, with most being intersphincteric resections and transanal hand-sewn anastomoses. In our study, 70 % of anastomoses were established via circular stapler. The significance of using a circular stapler in hNOTES lies in the ability to extend the indication to higher rectal lesions. We believe that secure stapling anastomosis can possibly decrease the rate of protective stoma use. However, length of the spike shaft of circular staplers needs to be elongated to befit the transanal approach. In our study, all cases achieved negative surgical margins, and only one case had a circumferential margin less than 3 mm, with margins less than 3 mm considered as an increase in the likelihood of local recurrence [15]. The mean number of retrieved lymph nodes was nineteen (range 10–35), comparable to other series. In terms of the transanal surgery platform used, we chose the Gelpoint Path, while some other series chose the transanal endoscopic operation (TEO) System (Karl Storz, Germany) [1, 7]. Neither of these devices is in fact specifically designed
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Table 4 Summary of hybrid NOTES series reported Study
de Lacy et al. [3]
Rouanet et al. [7]
Velthuis et al. [5]
Sylla et al. [2]
Our study
Number of cases
20
30
5
5
20
Male/Female
11/9
30/0
3/2
3/2
11/9
Age (years)a
65 (44–77)
65 (43–82)
69 (63–79)
48 (36–63)
57 (34–78)
BMI (kg/m2)a
25.3 (19–33)
26.0 (21–32.4)
No data
25.7 (22–28)
20.7 (21–31)
Tumor Location (cm, AAVb)
6.5a (2–15)
0–5: 20 p’ts
6a (5–8)
5.7a (4–10)
5.9a (2–8)
5-10: 10 p’ts Preop CCRT (%) Transanal device
70 Gelpoint path ± lone star retractor
97 TEO
100 SILS port (Covidien, USA)
40 TEOc
55 Gelpoint Path
Transabdominal via single port
No data
No data
Yes (80 %)
No data
Yes (75 %)
a
d
a
d
Operative time (minutes)
235 (150–325)
304 (120–432)
175 (160–194)
275 (214–423)
201a (110–285)
Estimated blood loss (ml)a
45 (10–110)
No data
No data
166 (80–300)
68 (30–500)
Splenic flexure mobilization
No data
Yes (100 %)
No data
No data
Yes (20 %)
Protective enterostomy (%)
80
100
100
100
85
Anastomosis method (H/S)e Intra-op complications
65 %/35 % None
No data 17 %
40 %/60 % 20 %
100 %/0 % None
30 %/70 % 5% (bleeding)
Postop complications (%)
20
27
40
60
25
Hospital days (Postop)
6.5a
14d (9–25)
No data
5.2a (4–10)
15.9
13 (8–32)
12 (11–17)
33 (16–53)
19.7a (10–35)
Positive margins (%)
0
13
0
0
0
Circumferential margin distance (mm) a
a
2.6 (0.7–5) a
18 (5–30)
d
d
0.9 (0.3–4) d
7 (0–17)
d
No data No data
d
8.9a (6–16)
Retrieved lymph nodes Distal margin distance (cm)
a
a
3.6 (0.8–10) a
7 (2–11)
2.4a (0.5–4) 15.2a (2–20)
Indicates mean value (range)
b
AAV Above Anal Verge
c
TEO Transanal Endoscopic Operation (TEO) System
d
Indicates median value (range)
e
H/S Hand-Sewn/Circular Stapler
for taNOTES. While the TEO is capable of achieving a tighter seal, device set-up is more complicated, and the videoscope is fixed in a downward thirty-degree angle, which renders upward dissection difficult to perform without readjusting the entire machinery. In comparison, the Gelpoint Path is easier to set up and more distensible, correlating to fewer postoperative anal function effects. In addition, the operating surgeon can determine the port location at will, and a larger visual field achieved through existing laparoscopic equipment and videoscope facilitates easier dissection at various angles. However, the Gelpoint Path is limited by its shorter anoscope length, complicating treatment of lesions higher up in the bowel tract. This shortcoming should hopefully soon be resolved via modification of existing equipment or development of new versions. Transanal single stapling requires purse-string suturing of the distal rectal stump. If the dividing line of the distal
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rectal stump was above the anorectal junction, purse-string suture would be performed with transanal port retained—a technically demanding procedure. Sylla and Lacy et al. had suggested removing the transanal platform and performing the purse-string suture under direct vision using anal retractors, to avoid incomplete purse-string issues [2, 3, 13]. We pursued with the port in position due to ease, and our stapling donuts were complete without air leak in inflation tests in all cases. An innovation in our study was the utilization of a simultaneous two-team approach—a rarity in abdominal and pelvic surgical scenarios. Eight patients underwent the two-team approach, significantly shortening operative time by more than 1 h (229 vs. 157 min). In this way, hNOTES has a potential advantage over pure NOTES as operation time is regarded. Via the two-team approach, the transabdominal team not only finished upper part dissection, but could also help the transanal team in deciding the proper
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dissection line near opening the peritoneal reflection to avoid excessive lateral or anterior dissection. Furthermore, once the peritoneal reflection has been opened, machinery from both approaches can help each other in traction and effectively accelerate the operative procedure. However, the downsides to a two-team approach also warrant delineation. Apart from having to use two laparoscopic systems and two teams of personnel, the right-head-down Trendelenburg position that facilitates transabdominal approach increases the transanal team’s difficulty in pelvic cavity dissection. The deviated axis not only predisposes to excessive lateral dissection but also increases the difficulty of identifying nerve bundles during promontory dissection. Therefore, the transanal team surgeon should be a highly experienced laparoscopic surgeon. In addition, initial protocols setting the CO2 pressure at 9 mmHgb as suggested by Sylla et al. [1] for transanal approach sets up a pressure difference between the two sides that renders the visual field unstable before an anatomical connection was made in between. We gradually increased the pressure to 12 mmHg, and the condition was improved. It is our suggestion that if lower pressure was preferred for the transanal approach, the air inflation machinery should adopt a continuous infusion model instead of a pulsatile infusion type. Conventional laparoscopic surgery has always been bothered by a difficulty in determining the most appropriate distal resection location for achieving proper distal margins, especially in cases involving middle and lower rectal cancers or shrunken tumors post neoadjuvant CCRT. hNOTES provides a solution to this difficulty by a pursestring suture to close off the bowel tract and mark the distal resection location, thereby definitively achieving a sufficient distal margin. A further advantage, as outlined by Lacy et al., is the reduced need for multiple stapler firings in transecting the rectum, consequently decreasing anastomotic leakage rates [16] and allowing for an additional 1–1.5 cm in the distal resection margin [3] when a circular stapler is used to recreate bowel tract continuity. In our study, the mean distal resection margin achieved was 2.4 ± 0.98 cm, which meets the oncological principle requirement of a distal resection margin of greater than 2 cm in lower rectal surgery. Our study is only a preliminary report of hNOTES with pathological parameters meeting oncological criteria. So far, the study completed by Rouanet et al. [7] is the only one with short-term follow-up data, yielding a median follow-up time of 21 months (range 10–41) and a two-year overall survival and relapse-free survival rate of 80.5 and 88.9 %, respectively. However, one point to note is that the cases enrolled in Rouanet’s series were not only more difficult to operate on but also more difficult to achieve negative surgical margins.
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As surgical experience accumulated, both leading surgeons had the same impression and confidence that hNOTES has the potential to become an option for rectal tumor excision of difficult pelvic dissection. This confidence is reflected via the rapid speed of case collection in this series. The evolution of hNOTES into pure NOTES will require innovative techniques and technologies, particularly of those able to completely mobilize the splenic flexure. These developments, along with further standardization of the surgical procedure, will help mold the future of hNOTES. Currently, our experience reveals that performing the aforementioned surgical procedures through the single-incision platform is not difficult and does not differ significantly from performing them through conventional laparoscopic surgery.
Conclusion Hybrid NOTES for rectal cancer is safe and feasible. Rapid experience-building accelerates its evolution, as reflected here by high stapling rates and the idea of a two-team approach. It has the potential to become an option of treating rectal cancers. Further randomized studies are needed to compare functional and oncological results. Disclosures Drs. Chien-Chih Chen, Yi-Ling Lai, Jeng-Kae Jiang, Chun-Ho Chu, I-Ping Huang, Wei-Shone Chen, Shung-Haur Yang, and Andy Yi-Ming Cheng have no conflicts of interest or financial ties to disclose.
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and Other Interventional Techniques
The evolving practice of hybrid natural orifice transluminal endoscopic surgery (NOTES) for rectal cancer Chien-Chih Chen • Yi-Ling Lai • Jeng-Kae Jiang • Chun-Ho Chu • I-Ping Huang • Wei-Shone Chen • Andy Yi-Ming Cheng • Shung-Haur Yang
Received: 6 February 2014 / Accepted: 23 May 2014 / Published online: 2 July 2014 Ó Springer Science+Business Media New York 2014
Abstract Background Natural orifice transluminal endoscopic surgery (NOTES) has emerged as the area of focus in laparoscopic surgery. Hybrid NOTES (hNOTES) has some potential advantages for treating rectal cancer. Methods Between May 2013 and November 2013, a total of 20 patients (11 males) who received hNOTES at two institutes participating in the study were documented and reviewed. Surgical outcomes, including complications and pathological outcomes, were analyzed. Results The mean age of patients was 57.8 ± 10.1 years (range 34–78). Eleven patients received preoperative neoadjuvant chemoradiotherapy, with the mean distance between tumor and anal verge being 5.9 ± 1.7 cm (mean 2–8). The mean estimated intraoperative blood loss was 68 ± 106 ml (range 30–500), with one case converted to open procedure due to uncontrolled bleeding. Eight cases underwent simultaneous two-team approach. The mean operative time was 200.8 ± 47.7 min (range 110–285). Circular stapling was performed for 14 cases (70 %) as the anastomosis, and protective stoma performed for 17 cases
C.-C. Chen Y.-L. Lai C.-H. Chu I.-P. Huang Department of Surgery, Koo Foundation, Sun Yat-Sen Cancer Center, Taipei, Taiwan C.-C. Chen J.-K. Jiang C.-H. Chu W.-S. Chen S.-H. Yang College of Medicine, National Yang-Ming University, Taipei, Taiwan J.-K. Jiang W.-S. Chen S.-H. Yang (&) Division of Colorectal Surgery, Taipei Veterans General Hospital, No 201, Sec 2, Shih-Pai Rd, Taipei 11217, Taiwan e-mail: [email protected] A. Y.-M. Cheng Boston University School of Medicine, Boston, MA, USA
(85 %). The overall postoperative complication rate was 25 %. Two cases (10 %) develop pelvic abscess due to leakage, which were controlled by medical treatments. The distal and circumferential margins were all free of tumor cells, and the mean distal margin length was 2.4 ± 0.98 cm (range 0.5–4). Conclusions Hybrid NOTES for rectal cancer is safe and feasible. Rapid experience-building accelerates its evolution, as reflected here by the high stapling rate and the idea of a two-team approach. It has the potential to become an option of treating rectal cancers. Keywords Natural orifice transluminal endoscopic surgery (NOTES) Laparoscopic surgery Rectal cancer Transanal TME
Background Natural orifice transluminal endoscopic surgery (NOTES) has emerged as a focused area of laparoscopic surgery. Compared to transvaginal and transgastric approaches, hybrid NOTES (hNOTES) incorporating abdominal and transanal approaches is currently a more suitable route in the field of colorectal surgery [1, 2]. The transanal approach avoids damaging existing non-diseased organs by creating an enterostomy through the diseased organ and incorporating itself into the standard colorectal anastomosis [3]. Potential advantages of transanal approach of NOTES include facilitation of precise dissection in the low pelvic presacral, perirectal, and anterior rectal wall planes [3, 4], obtainment of a sufficient distal margin under direct visualization [5], and avoidance of multiple staples in dividing the rectal stump [3]. Apart from recent literature outlining hNOTES [2, 3, 6, 7], Leroy et al. and Zheng et al.
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have published case reports of pure transanal NOTES (taNOTES) without any abdominal wounds [8, 9]. Prospective randomized trials have already shown that laparoscopic rectal surgery improves short-term postoperative recovery without compromising the safety and completeness of resection compared to open rectal surgery [10, 11]. Laparoscopic rectal surgery is technically demanding, with a conversion rate of 17–29 % [10]. Nonetheless, whether performed via an open or conventional laparoscopic approach, total mesorectal excision (TME) presents difficulties in several conditions such as low-lying lesions, male gender, obesity, and preoperative neoadjuvant therapies. hNOTES might provide another option in navigating these conditions, as it has better visual monitoring and shorter working distance than in the abdominal approach of conventional laparoscopy [12]. In this series, we attempt to analyze our cases, with the first aim to evaluate the safety and feasibility of hNOTES in proctectomy of both low anterior and TME with coloanal anastomosis, and the second to present some new aspects of this rapidly evolving surgery.
Materials and methods Between May 2013 and November 2013, twenty patients with biopsy-proven rectal adenocarcinoma, precancerous lesions, or neuroendocrine tumor receiving hNOTES in Sun-Yat-Sen Cancer Center (led by CCC) or Taipei Veteran’s General Hospital (led by SHY) were documented and reviewed. Patients were cleared from laparoscopic surgery contraindications during preoperative evaluation and were fully informed of the risks and benefits of the hNOTES technique. Each patient provided informed consent, which was then documented into a database approved by each institution’s IRB. Each facility utilized its own surgical team, but had similar principles regarding the transanal approach. All patients underwent initial systemic evaluations before treatment, including physical exam, digital rectal exam, complete colonoscopy, chest X-ray, tumor marker documentation, abdominal ultrasound, and pelvic magnetic resonance imaging or chest and abdominal computed tomography scan. Patients of rectal adenocarcinoma with T3N0 or N (?) received preoperative concurrent chemoradiotherapy (CCRT) as neoadjuvant therapy, while those with pathologically confirmed premalignant lesions or neuroendocrine tumors proceeded directly to surgery. Patients requiring CCRT received one course of radiotherapy delivered by intensity modulated radiation therapy (IMRT) performed at 5,040 Gy in combination with oral form 5-FU upon initial administration of radiotherapy.
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Fig. 1 Operative setting of the equipments and personnels
Radiotherapy proceeded at 4,500 cGy in 25 fractions to the pelvis, followed by 540 cGy in 2 fractions directed at the primary tumor site. Once CCRT was completed, patients were re-evaluated with the same pre-treatment protocols before receiving radical surgery with curative intent 6–8 weeks after completion of CCRT.
Surgical technique and postoperative care The hybrid abdominal and transanal approaches were adopted. Except for minor adaptations made in response to specific patient scenarios, we tried to standardize the procedure step-by-step as detailed below: 1.
2.
Abdominal approach started with a 12 mm trocar inserted through the umbilicus, and a 30-degree-angle rigid videoscope was utilized to visualize the peritoneal cavity. Once the cavity was deemed suitable for laparoscopic surgery, the 12 mm trocar was replaced with a single-incision platform (Gelpoint, Applied Medical, USA), and a 5 mm trocar was placed in the right lower abdominal quadrant. Extra trocars could be added if needed. Abdominal approach aimed to complete ligation of the inferior mesenteric artery and vein, mobilization and division of the sigmoid mesocolon, and division of Toldt’s line. Peritoneal reflection could be opened via abdominal or transanal approach, without rigid regulation.
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Fig. 2 A Made circular division in the posterior rectal wall to gain entrance into the perirectal space. B Opened the peritoneal reflection in the pelvis, transanally. C Closed the rectal stump with purse-string suture, and applied circular stapler
3.
4.
5.
6.
7.
Transanal approach could be started simultaneously with the abdominal approach in a two-team approach, or later after finishing abdominal approach in a oneteam approach (Fig. 1). The adequate distal resection margin was decided first. If it was at the anorectal junction, or further downward in the anal canal, a circular whole layer depth of rectum would be dissected as usual. Then, purse-string suture was done to close the stump. Upward dissection was then accomplished via a multiple port transanal device (GelPOINT Path, Applied Medical, USA) under CO2 insufflation to 9 mmHg. If adequate resection margin could be obtained while sparing 2–3 cm of lower rectum above the anorectal junction, transanal device would then be set up directly. This length of distal rectum was prepared for final circular staple anastomosis. In this way, circular purse-string to occlude the rectal lumen was done first under GelPOINT Path platform, and then the rectum was divided circularly to gain entrance into the perirectal space (Fig. 2A). The purse-string suture could be made by hand-sewing through the anoscope of GelPOINT or by laparoscopic instruments under CO2 insufflation. With access into the presacral avascular plane, the mesorectum was mobilized upward to the promontory region, and the anterior rectal wall was carefully separated from the vagina or prostate to ensure quality of circumferential margins. Dissecting as deeply as possible in the presacral avascular plane is suggested, as this plane is easy to recognize. The peritoneal reflection in the pelvis was reached (Fig. 2B), and the whole rectum was mobilized up to the recto-sigmoid junction, thereby joining the peritoneal cavity and completing the dissection. Due to lack of anatomical landmarks over bilateral sides, dissection along the anterior and posterior aspects first was suggested. Then, the lateral ligaments of both
8.
9.
10.
11.
sides were easier to distinguish from surrounding tissue, and therefore, the hemorrhoid vessels easier to divide. The lesion was subsequently removed either abdominally or transanally, depending on the specimen size and anorectum diameter. Length of the distal rectal stump determined whether a transanal hand-sewn coloanal anastomosis or circular stapler was used to re-establish continuity of the bowel. If the circular stapler was used, the pursestring suture that closed the distal rectal stump was performed transanally. This hand-sewn purse-string suture was performed through the anoscope, with or without CO2 insufflations, depending on the rectal stump length. Purse-string suture was carefully done to ensure full-thickness of rectum encompassed in full circumference. There were two ways of tying purse-strings and performing the circular stapling anastomosis: transanal or abdominal method. The transanal method included tying both purse-strings of the proximal and distal stump onto the shaft of the anvil, as reported by Lacy et al. [13]. The anvil and the spike were connected in the correct position under visualization from the anal side and an end-to-end anastomosis was performed. The other abdominal method differed in tying the purse-string of distal stump directly, without anvil shaft inside. Then, under guidance from abdominal visualization, the instrument spike tip pierced transanally the very tiny slit of the previously tied stump (Fig. 2C). Extending the spike tip to its full length was then helped by the grasper from the abdominal side, and the anastomosis was finished under abdominal guidance as done in conventional laparoscopy. The anastomosis completeness was checked via air inflation test. A 10 mm Jackson-Pratt drain was routinely placed in the pelvis through the right lower abdominal quadrant 5 mm trocar site.
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Table 1 Demographic and preoperative information
Table 2 Operative characteristics
Total number of patients
20
Estimated blood loss (ml)
Male:Female
11(55 %):9(45 %)
68 ± 106 (range 30–500)
Age (years)
57.8 ± 10.1 (range 34–78)
Number of laparoscopic trocarsa
2 ± 0.6 (range 2–4)
ASA grade (I/II/III)
5(25 %)/14 (70 %)/1(5 %)
Two-team approach
BMI (kg/m2)
24.7 ± 3.0 (range 20.7–30.9)
Histology (NECb/Adenocarcinoma/ Benign)
3(15 %)/16(80 %)/1(5 %)
Clinical TNM Stage (I/II/III) Tumor location (cm from anal verge)
4(20 %)/6(30 %)/7(35 %) 5.9 ± 1.7 (range, 2-8)
Two-team
157.5 ± 31.7 (range 110–215)
Neoadjuvant chemoradiation (Yes/No)
11(55 %)/9(45 %)
One-team
CEA Level (ng/ml; normal value B 5)
4.12 ± 3.89 (range 0.80–14.88)
229.6 ± 32.0 (range 190–285)
Previous abdominal surgery (Yes/No)
1(5 %)/19(95 %)
a
a b
ASA American Society of Anesthesiologists NEC Neuroendocrine Carcinoma
12.
Diverting enterostomy or not, either an ileostomy or transverse loop colostomy was decided individually by the operating surgeon.
All patients received postoperative intravenous or epidural pain control, and oral intake began immediately after surgery. Postoperative care and discharge criteria were as outlined by the enhanced recovery program detailed in our previous publication [14].
Statistical analysis Data were analyzed using an SPSS Package (Statistical Product and Service Solutions 16.0 for Macintosh, SPSS Inc., Chicago, IL, USA), and continuous data were expressed as mean ± standard error of the mean. Categorical variables were reported as counts and percentages.
Yes
8 (40 %)
No
12 (60 %)
Operative time (min)
200.8 ± 47.7 (range 110–285)
Anastomosis method Hand-sewn coloanal
6 (30 %)
Circular stapler
14 (70 %)
Splenic flexure mobilization Yes No Diverting enterostomy None
4 (20 %) 16 (80 %) 3 (15 %)
T-loop colostomy
12 (60 %)
Loop Ileostomy
5 (25 %)
Complication Intraoperative complication: bleeding (conversion to open surgeryb) Postoperative complications
6 (30 %) 1 (5 %) 5 (25 %)
Pelvic abscess
2 (10 %)
Urinary retention after
3 (15 %)
Foley removal Hospital stay (days)c
8.85 ± 2.5 (range 6–16)
Readmission after discharged
1 (5 %)
a
15 cases used the single-incision platform as the transabdominal route
b
Reason for conversion: bleeding
c
Postoperative days Reason: fever, status post conservative treatment
d
Results Demographic and preoperative information of 20 patients (11 males) is summarized in Table 1. One patient was ASA grade III, and one other had previous abdominal surgery. Eleven patients (55 %) received preoperative neoadjuvant chemoradiotherapy. Table 2 summarizes operative details. The mean operative blood loss was acceptable. There was a case (5 %) of intraoperative complication. An uncontrolled bleeding during dissection of the presacral plane with an estimated blood loss of 500 ml required conversion to open surgery for adequate hemostasis. There was no bowel perforation during procedures. Two cases needed extra abdominal
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trocars. The mean operative time was 200.8 ± 47.7 min (range 110–285). Two-team approach was applied for eight cases, achieving significantly shorter operative time than that achieved in the one-team approach (P = 0.01). In terms of anastomosis, the hand-sewn method was used in only six cases, while circular stapling was used for the other 14 cases (70 %), all by single stapling method. Four cases needed splenic flexure mobilization to achieve tension-free anastomosis. The only three cases without protective stoma were performed during the later period of this series, and all received circular stapling without leakage in recovery.
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There were 5 cases (25 %) of postoperative complications, including 2 cases of pelvic abscess due to anastomosis leakage, and 3 cases of urinary retention. There was no wound infection. The two cases of pelvic abscess required a prolonged hospital stay (10 and 13 days), with the abscesses subsiding after antibiotic treatment without further radiological or surgical intervention. Three patients had urinary retention after Foley removal and needed recatheterization. The patient with longest duration of urinary catheter retention had a history of prominent prostatism, and the catheter could not be removed until 2 months later. The only one case needing readmission was due to fever three days after discharge. The fever subsided two days later, with no specific origin identified. Table 3 summarizes pathological results. Besides 17 cases of adenocarcinoma, there were 3 cases of neuroendocrine tumors: one carcinoma and two carcinoid with regional lymph node metastasis. Distal margin distance and number of harvested lymph nodes were acceptable; the one case of 0.5 cm margin was that of an adenoma with intramucosal adenocarcinoma (Tis). The distal and circumferential margins were free of tumor cells in all twenty cases; only one case had a circumferential margin distance less than 3 mm, accounting for 7 %. Of the 11 cases that
Table 3 Pathological characteristics Histology Adenocarcinoma
17 (85 %)
Neuroendocrine tumor
3 (15 %)
Differentiation Well
3 (15 %)
Moderately
16 (80 %)
Poorly
1 (5 %)
Maximum tumor diameter (cm)
1.80 ± 1.06 (range, 0.3–3.5)
Lymphovascular Invasion Yes
5 (25 %)
No
15 (75 %)
Distal margin distance (cm)
2.40 ± 0.98 (range, 0.5–4)
Number of retrieved lymph nodes
19.7 ± 6.4 (range, 10–35)
Circumferential margin distancea (mm)
15.2 ± 6.7 (range, 2–20)
\3
1 (7 %)
C3
14 (93 %)
TNM Stage (for adenocarcinoma and adenoma) I 6 (30 %)
a
IIa/IIb
5 (25 %)/1 (5 %)
IIIa/IIIb
3 (15 %)/1 (5 %)
Tis
1 (5 %)
Complete remission
2 (10 %)
Data pertinent to 15 patients
required preoperative CCRT, pathological complete remission was documented in two cases.
Discussion Our series revealed that hNOTES for rectal tumor excision is safe and feasible. Two points reflect the rapidly evolving techniques in this field here: the high percentage of circular stapler application, and the innovation of a two-team approach. One bleeding complication happened during the early period of this series. As surgical experience accumulated quickly, this complication did not happen again when we became familiar with the anatomy viewed via the transanal approach. Five cases (25 %) had postoperative complications. Two cases developing pelvic abscess received protective ileostomy in advance, thereby facilitating resolution under antibiotics without requiring additional radiologic or surgical intervention. Three patients developed urinary retention after Foley catheter removal and required recatheterization. Urinary retention in existing published studies accounted for 6–40 % of postoperative complications [2, 3, 7]. Theoretically, hNOTES has the advantage of preserving autonomic nerve function when compared to conventional laparoscopy. Under better visualization and shorter working distance, hNOTES would lead to less likely over-dissection of Denovillie’s fascia and preserve neurovascular bundles on either side of the prostate than conventional laparoscopy would. However, this issue remains to be further studied. Table 4 summarizes existing literature with case numbers greater than five focusing on hNOTES [2, 3, 5, 7]. The majority of published series begins the transanal approach at the dentate line, with most being intersphincteric resections and transanal hand-sewn anastomoses. In our study, 70 % of anastomoses were established via circular stapler. The significance of using a circular stapler in hNOTES lies in the ability to extend the indication to higher rectal lesions. We believe that secure stapling anastomosis can possibly decrease the rate of protective stoma use. However, length of the spike shaft of circular staplers needs to be elongated to befit the transanal approach. In our study, all cases achieved negative surgical margins, and only one case had a circumferential margin less than 3 mm, with margins less than 3 mm considered as an increase in the likelihood of local recurrence [15]. The mean number of retrieved lymph nodes was nineteen (range 10–35), comparable to other series. In terms of the transanal surgery platform used, we chose the Gelpoint Path, while some other series chose the transanal endoscopic operation (TEO) System (Karl Storz, Germany) [1, 7]. Neither of these devices is in fact specifically designed
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Table 4 Summary of hybrid NOTES series reported Study
de Lacy et al. [3]
Rouanet et al. [7]
Velthuis et al. [5]
Sylla et al. [2]
Our study
Number of cases
20
30
5
5
20
Male/Female
11/9
30/0
3/2
3/2
11/9
Age (years)a
65 (44–77)
65 (43–82)
69 (63–79)
48 (36–63)
57 (34–78)
BMI (kg/m2)a
25.3 (19–33)
26.0 (21–32.4)
No data
25.7 (22–28)
20.7 (21–31)
Tumor Location (cm, AAVb)
6.5a (2–15)
0–5: 20 p’ts
6a (5–8)
5.7a (4–10)
5.9a (2–8)
5-10: 10 p’ts Preop CCRT (%) Transanal device
70 Gelpoint path ± lone star retractor
97 TEO
100 SILS port (Covidien, USA)
40 TEOc
55 Gelpoint Path
Transabdominal via single port
No data
No data
Yes (80 %)
No data
Yes (75 %)
a
d
a
d
Operative time (minutes)
235 (150–325)
304 (120–432)
175 (160–194)
275 (214–423)
201a (110–285)
Estimated blood loss (ml)a
45 (10–110)
No data
No data
166 (80–300)
68 (30–500)
Splenic flexure mobilization
No data
Yes (100 %)
No data
No data
Yes (20 %)
Protective enterostomy (%)
80
100
100
100
85
Anastomosis method (H/S)e Intra-op complications
65 %/35 % None
No data 17 %
40 %/60 % 20 %
100 %/0 % None
30 %/70 % 5% (bleeding)
Postop complications (%)
20
27
40
60
25
Hospital days (Postop)
6.5a
14d (9–25)
No data
5.2a (4–10)
15.9
13 (8–32)
12 (11–17)
33 (16–53)
19.7a (10–35)
Positive margins (%)
0
13
0
0
0
Circumferential margin distance (mm) a
a
2.6 (0.7–5) a
18 (5–30)
d
d
0.9 (0.3–4) d
7 (0–17)
d
No data No data
d
8.9a (6–16)
Retrieved lymph nodes Distal margin distance (cm)
a
a
3.6 (0.8–10) a
7 (2–11)
2.4a (0.5–4) 15.2a (2–20)
Indicates mean value (range)
b
AAV Above Anal Verge
c
TEO Transanal Endoscopic Operation (TEO) System
d
Indicates median value (range)
e
H/S Hand-Sewn/Circular Stapler
for taNOTES. While the TEO is capable of achieving a tighter seal, device set-up is more complicated, and the videoscope is fixed in a downward thirty-degree angle, which renders upward dissection difficult to perform without readjusting the entire machinery. In comparison, the Gelpoint Path is easier to set up and more distensible, correlating to fewer postoperative anal function effects. In addition, the operating surgeon can determine the port location at will, and a larger visual field achieved through existing laparoscopic equipment and videoscope facilitates easier dissection at various angles. However, the Gelpoint Path is limited by its shorter anoscope length, complicating treatment of lesions higher up in the bowel tract. This shortcoming should hopefully soon be resolved via modification of existing equipment or development of new versions. Transanal single stapling requires purse-string suturing of the distal rectal stump. If the dividing line of the distal
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rectal stump was above the anorectal junction, purse-string suture would be performed with transanal port retained—a technically demanding procedure. Sylla and Lacy et al. had suggested removing the transanal platform and performing the purse-string suture under direct vision using anal retractors, to avoid incomplete purse-string issues [2, 3, 13]. We pursued with the port in position due to ease, and our stapling donuts were complete without air leak in inflation tests in all cases. An innovation in our study was the utilization of a simultaneous two-team approach—a rarity in abdominal and pelvic surgical scenarios. Eight patients underwent the two-team approach, significantly shortening operative time by more than 1 h (229 vs. 157 min). In this way, hNOTES has a potential advantage over pure NOTES as operation time is regarded. Via the two-team approach, the transabdominal team not only finished upper part dissection, but could also help the transanal team in deciding the proper
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dissection line near opening the peritoneal reflection to avoid excessive lateral or anterior dissection. Furthermore, once the peritoneal reflection has been opened, machinery from both approaches can help each other in traction and effectively accelerate the operative procedure. However, the downsides to a two-team approach also warrant delineation. Apart from having to use two laparoscopic systems and two teams of personnel, the right-head-down Trendelenburg position that facilitates transabdominal approach increases the transanal team’s difficulty in pelvic cavity dissection. The deviated axis not only predisposes to excessive lateral dissection but also increases the difficulty of identifying nerve bundles during promontory dissection. Therefore, the transanal team surgeon should be a highly experienced laparoscopic surgeon. In addition, initial protocols setting the CO2 pressure at 9 mmHgb as suggested by Sylla et al. [1] for transanal approach sets up a pressure difference between the two sides that renders the visual field unstable before an anatomical connection was made in between. We gradually increased the pressure to 12 mmHg, and the condition was improved. It is our suggestion that if lower pressure was preferred for the transanal approach, the air inflation machinery should adopt a continuous infusion model instead of a pulsatile infusion type. Conventional laparoscopic surgery has always been bothered by a difficulty in determining the most appropriate distal resection location for achieving proper distal margins, especially in cases involving middle and lower rectal cancers or shrunken tumors post neoadjuvant CCRT. hNOTES provides a solution to this difficulty by a pursestring suture to close off the bowel tract and mark the distal resection location, thereby definitively achieving a sufficient distal margin. A further advantage, as outlined by Lacy et al., is the reduced need for multiple stapler firings in transecting the rectum, consequently decreasing anastomotic leakage rates [16] and allowing for an additional 1–1.5 cm in the distal resection margin [3] when a circular stapler is used to recreate bowel tract continuity. In our study, the mean distal resection margin achieved was 2.4 ± 0.98 cm, which meets the oncological principle requirement of a distal resection margin of greater than 2 cm in lower rectal surgery. Our study is only a preliminary report of hNOTES with pathological parameters meeting oncological criteria. So far, the study completed by Rouanet et al. [7] is the only one with short-term follow-up data, yielding a median follow-up time of 21 months (range 10–41) and a two-year overall survival and relapse-free survival rate of 80.5 and 88.9 %, respectively. However, one point to note is that the cases enrolled in Rouanet’s series were not only more difficult to operate on but also more difficult to achieve negative surgical margins.
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As surgical experience accumulated, both leading surgeons had the same impression and confidence that hNOTES has the potential to become an option for rectal tumor excision of difficult pelvic dissection. This confidence is reflected via the rapid speed of case collection in this series. The evolution of hNOTES into pure NOTES will require innovative techniques and technologies, particularly of those able to completely mobilize the splenic flexure. These developments, along with further standardization of the surgical procedure, will help mold the future of hNOTES. Currently, our experience reveals that performing the aforementioned surgical procedures through the single-incision platform is not difficult and does not differ significantly from performing them through conventional laparoscopic surgery.
Conclusion Hybrid NOTES for rectal cancer is safe and feasible. Rapid experience-building accelerates its evolution, as reflected here by high stapling rates and the idea of a two-team approach. It has the potential to become an option of treating rectal cancers. Further randomized studies are needed to compare functional and oncological results. Disclosures Drs. Chien-Chih Chen, Yi-Ling Lai, Jeng-Kae Jiang, Chun-Ho Chu, I-Ping Huang, Wei-Shone Chen, Shung-Haur Yang, and Andy Yi-Ming Cheng have no conflicts of interest or financial ties to disclose.
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