Surg Endosc DOI 10.1007/s00464-015-4170-5
and Other Interventional Techniques
DYNAMIC MANUSCRIPT
Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis Xavier Serra-Aracil1 • Laura Mora-Lo´pez1 • Alex Casalots2 • Carles Pericay3 Raul Guerrero1 • Salvador Navarro-Soto1
•
Received: 5 November 2014 / Accepted: 2 March 2015 Springer Science+Business Media New York 2015
Abstract Background Laparoscopic surgery for rectal TME achieves better patient recovery, lower morbidity, and shorter hospital stay than open surgery. However, in laparoscopic rectal surgery, the overall conversion rate is nearly 20 %. Transanal TME combined with laparoscopy, known as Hybrid NOTES, is a less invasive procedure that provides adequate solutions to some of the limitations of rectal laparoscopy. Transanal TME via TEO with technical variants (intracorporeal resection and anastomosis, TEO review of the anastomosis) attempts to standardize and simplify the procedure. Method Prospective observational study was used describe and assess the technique in terms of conversion to open surgery, overall morbidity, surgical site infection and hospital stay. The sample comprised consecutive patients diagnosed with rectal tumor less than 10 cm from the anal verge who were candidates for low anterior resection using TME (except T4). Demographic, surgical, postoperative,
Electronic supplementary material The online version of this article (doi:10.1007/s00464-015-4170-5) contains supplementary material, which is available to authorized users. & Xavier Serra-Aracil [email protected]; [email protected] 1
Coloproctology Unit, General and Digestive Surgery Service, Parc Taulı´ University Hospital, Universidad Autonoma de Barcelona, Parc Taulı´ 1, 08208 Sabadell, Barcelona, Spain
2
Pathology Service, Parc Taulı´ University Hospital, Universidad Autonoma de Barcelona, Sabadell, Barcelona, Spain
3
Medical Oncology Service, Parc Taulı´ University Hospital, Universidad Autonoma de Barcelona, Sabadell, Barcelona, Spain
and pathological variables were analyzed, as well as morbidity rates. Results From September 2012 to August 2014, 32 patients were included. The conversion rate was 0 %. Overall morbidity was 31.3 %, SSI rate was 9.4 %, and mean hospital stay was 8 days. Oncological radical criteria were achieved with pathological parameters of 94 % of complete TME and a median circumferential margin of 13 mm. Conclusion The introduction of technical variants of TEO for transanal resection can facilitate a procedure that requires extensive experience in transanal and laparoscopic surgery. Studies of sphincter function, quality of life, and long-term oncological outcome are now necessary. Keywords Transanal excision Transanal TME TEO TEM NOTES Hybrid NOTES
Introduction The expansion of laparoscopy for rectal cancer reflects the trend toward less invasive surgical techniques. Its application should maintain the principles of oncologic resection obtained with total mesorectal excision (TME) proposed by Heald [1]. The COLOR II study [2], one of the largest prospective randomized studies of open and laparoscopic surgery, found that laparoscopy achieves faster patient recovery and reduces hospital stay. However, it is not feasible in all patients: the conversion rate to open surgery is 17 %, and this figure increases in patients with narrow pelvis. Since the first description of transanal endoscopic microsurgery (TEM) by Buess [3] for local excision of rectal tumors, the application of this surgery has expanded to other rectal and pelvic diseases, which are usually treated via an abdominal approach using laparotomy or
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laparoscopy. These indications are termed ‘‘atypical,’’ as they diverge from the standard application of the technique [4]. In recent years, an adaptation of TEM using natural orifices (known as NOTES: natural translumenal orifice endoscopic surgery) has been applied to access the peritoneal cavity and perform intra-abdominal operations [5, 6]. Benefits of this technique include the maintenance of the integrity of the abdominal wall and the reduction in the rate of trauma associated with conventional surgery. The experience gained with TEM, and the emergence of groups which have demonstrated the advantages of NOTES [7–9], has opened up new possibilities for the transanal approach in rectal surgery. Leroy et al. [10] reported their experience with pure NOTES, in which TME is performed entirely via a transanal approach. However, limitations and major technical difficulties have been described. More studies assessing these innovations are currently required, but in the meantime, a number of ‘‘hybrid’’ techniques have been reported [11–14] combining laparoscopy techniques with TEM. These techniques allow the use of laparoscopy to perform critical steps such as the dissection and control of the inferior mesenteric vessels, the dissection of the splenic flexure of the colon, control of the ureter, and performing anastomosis, all drawing on the experience already obtained in laparoscopy [15]. The first report of total transanal mesorectal excision (TME) using TEM equipment was published by Sylla [5]. In recent years, the use of the single port as transanal approach has become more widespread [11, 12, 16, 17], with extracorporeal removal of the specimen and anastomosis. At our center, we have extensive experience in TEM and transanal endoscopic operation (TEO) and have designed a new technical variant of hybrid NOTES: transanal TME using TEO equipment. Resection of the specimen and anastomosis are performed intracorporeally using TEO. The anastomosis can be created at the distance from the anal verge required, and the use of TEO allows subsequent review. In this study, we describe this technique and analyze the results obtained so far.
Patients and methods Design Prospective observational study. Patients Patients diagnosed with rectal adenocarcinoma after complete colonoscopy and biopsy. Subsequently, an extension
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study was performed with endorectal ultrasound, pelvic scan, abdominal CT, and chest radiography. All patients were assessed by the multidisciplinary committee of colorectal tumors at the Parc Taulı´ University Hospital, and the therapeutic strategy was determined in accordance with international protocols [18]. Inclusion criteria Patients with rectal cancer stage cT1-2-3, cN0-1, cM0, less than 10 cm from the anal verge who were candidates for TME [1], with or without preoperative chemoradiotherapy. Exclusion criteria Patients with cT4 tumor. All patients were operated upon by surgeons at the colorectal surgery unit at our center. All signed informed consent. Patients who were candidates for neoadjuvant treatment in accordance with our center’s protocol received 50.4 Gy at a daily dose of 1.8 Gy, 5 days a week for 6 weeks concomitantly with chemotherapy comprising the oral administration of capecitabine 825 mg/m2 every 12 h or 5-fluorouracil (5-FU) via infusion, 225 mg/m2/day. Preoperative preparation All patients underwent antegrade colonic lavage, antibiotic prophylaxis (amoxicillin–clavulanic Ac 2 g/i.v. or, in the case of allergy, metronidazole 1 g/i.v and gentamicin 3–5 mg/kg/i.v.) during anesthetic induction and thromboembolic prophylaxis (enoxaparin 40 mg/administered subcutaneously) in accordance with our protocol. Surgical technique (hybrid NOTES: TEO for transanal TME) The patient is placed in the Lloyd–Davis position for the modified laparoscopic approach. A Hasson umbilical trocar is used. The remaining trocars are introduced in the right iliac fossa (12 mm) and two (5 mm) on both flanks of the abdomen. The pneumoperitoneum is created with a pressure of 12 mmHg. Conventional rectal laparoscopic surgery is performed following the planes of the TME through the lower pelvis [1]. The section of the inferior mesenteric vessels is performed at their origin and the dissection of the splenic flexure as required. After sectioning the vessels and initiating the TME via laparoscopic approach, the TEO equipment (Karl Storz GMBH, Tu¨tlingen, Germany) is introduced transanally using a 15-cm rectoscope. The pneumorectum pressure should be 14 mm Hg, slightly higher than that of the pneumoperitoneum, to prevent collapse of the rectum. The
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technique begins with the creation of a purse string, at least 1 cm distal to the direct view of the tumor (Fig. 1A, B), using standard transanal endoscopic surgery [19, 20]. Profuse lavage of the excluded rectum with saline and povidone–iodine 1 % is performed with cytolytic intent. The area of the rectum to be sectioned is dotted with the electric scalpel at a distance of 1 cm from the purse string (Fig. 1C). The dissection progresses in the posterior part until the laparoscopic TME field is reached (Fig. 1D, E). It continues laterally until the anterior face through the Denonvilliers fascia in men and the rectovaginal plane in women (Video 1). Intracorporeal resection and anastomosis After the section of the rectum and TME transanal dissection, the anvil of the circular mechanical stapler is introduced through the TEO rectoscope (Fig. 2A). In the laparoscopic field, the mesosigma is sectioned at the point where the colon section is to be performed. As described by Akamatsu [21], the colon is opened distally to the area to be sectioned, and the anvil of the circular mechanical stapler is introduced in what will be the proximal colonic part of the anastomosis. The colon is sectioned with Endo GIA (CovidiebEndo GIATM Universal Stapling System) (Fig. 2B–E) (Video 2). An endobag (Applied-Medical. Inzii 12/15 mm Retrieval System) is inserted via a 12-mm trocar, in which the TME specimen is placed and led toward the pelvis (Fig. 3A–C). From the TEO rectoscope, the
strings of the bag are recovered and pulled. The TEO rectoscope is withdrawn, and the bag containing the specimen is removed through the anus (Fig. 3D–F) (Video 3). The TEO is repositioned, and a new purse string is created on the rectal stump. The sutures of the purse are introduced into the abdominal cavity, and the laparoscopic team recovers the ends of the strings. The TEO rectoscope is withdrawn and, through the anus, the stapler is inserted and the shaft placed in the middle of the purse. From the laparoscopic field, the strings of the purse are tightened and the purse is closed around the rectal stump with a clip or slip knot. Then the two parts of the circular stapler are joined to perform the anastomosis (Fig. 4A–D). The anastomosis is checked systematically via TEO, allowing easy repair of any defect or bleeding (Fig. 4E–G) (Video 4). The surgery is completed by placing a Jackson–Pratt drain in the pelvis and a loop ileostomy in the right flank. Study variables Main outcomes: overall morbidity, nosocomial infection, surgical site infection (SSI), conversion to open surgery, and hospital stay. Demographic variables: age, sex, ASA, body mass index, distance from the anal verge, tumor height (B6–[6 cm), neoadjuvant treatment. Surgical variables: Surgical time, type of anastomosis, protection ostomy, blood loss, and dissection of splenic flexure.
Fig. 1 Total mesorectal excision via TEO
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Fig. 2 Introduction of the anvil in the proximal colon
Fig. 3 Transanal removal of the specimen in a plastic bag
Pathology: distal resection margin, radial resection margin, mesorectal quality (Quirque [22]), number of adenopathies, and tumor stage.
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Postoperative variables and 30-day morbidity: oral tolerance, 30-day morbidity, incisional SSI, organocavitary SSI, anastomotic leak, and anastomotic leak surgery.
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Fig. 4 Colorectal mechanical anastomosis and review via TEO
Postoperative monitoring, data collection, and statistical analysis Since January 2005, the morbidity of all patients admitted to both the Colorectal Unit and the Department of General and Digestive Surgery has been prospectively recorded. The assessment of adverse effects is peer-reviewed [23]. Descriptive and statistical analyses were performed (SPSS, version 20, SPSS, Inc, Chicago, IL). For the quantitative variables, means and SD were used when the distribution was considered normal; otherwise, the median, interquartile interval, and range were used. Categorical variables are reported in absolute numbers and percentages.
Results Between September 2012 and September 2014, we have operated on 32 patients using hybrid NOTES with TEO and transanal TME. Patients were enrolled consecutively in
accordance with the inclusion criteria listed above, with the exception of the first five patients who were selected according to tumor size (less than 5 cm), location in the midrectum and BMI \ 30 kg/m2. Table 1 displays patients’ demographic data. Table 2 shows the surgical and postoperative variables. The median operative time is 240 min: initially, it was between 5 and 6 h, while the most recent interventions have lasted just over 3 h. All patients underwent protective loop ileostomy, except one patient in whom a loop colostomy was performed due to poor bowel preparation. No blood transfusions were required, and no patients were converted to open surgery. Most patients (80.6 %) tolerated oral diet within 5 days. Postoperative morbidity, estimated according to the POSSUM (Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity) [24] was 48 %. The estimated postoperative mortality according to the POSSUM, P-POSSUM (Portsmouth POSSUM) [25], and CR-POSSUM (Colorectal POSSUM) scales [26] was
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Surg Endosc Table 1 Descriptive analysis of demographic variables
Demographic variables
Patients (n = 32)
Age, years, median (IQR) (range)
68 (16) (39–88) years
Sex Male
24 (75 %)
Female
8 (25 %)
ASA II (%)
22 (68.75 %)
III (%)
10 (31.25 %)
IV (%)
0 (0 %)
BMI kg/m2
25 (6) (35–20) kg/m2
Distance from anal verge, median, IQR (range)
8 (3) (5–10) cm
Location of the rectal tumor Low rectum (B6 cm) (%)
12 (37.5 %)
Medium rectum ([6 cm) (%)
20 (62.5 %)
Neoadjuvant RCT (%)
16 (50 %)
IQR interquartile range, ASA American Society Anesthesiology, BMI Body Mass Index
Table 2 Descriptive analysis of surgical and postoperative variables
Surgical and postoperative variables
Patients (n = 32)
Surgical time, median (IQR) (range), minutes
240 (60) (165–360)
Anastomosis Manual coloanal (%)
2 (6.25 %)
Mechanical (%)
30 (93.75 %)
Defunction ostomy Ileostomy (%) Colostomy (%) Blood loss, median (IQR) (range) ml
31 (96.87 %) 1 158 (28.8) (105–230) ml
Dissection of splenic flexure
6 (18.75 %)
Rate of patients transfused
0 (0 %)
Conversion rate to open surgery
0 (0 %)
Oral tolerance \5 days
26 (81.25 %)
C5 days
6 (18.75 %)
Hospital stay, days, median (IQR) (range)
8 (7) (4–20) days
POSSUM morbidity %. Median (IQR) (range)
48 % (34 %) (15–92 %)
POSSUM mortality %, median (IQR) (range)
10 % (13 %) (3–47 %)
P-POSSUM mortality %. Median (IQR) (range)
2 % (3) (1–17 %)
CR-POSSUM mortality %, median (IQR) (range)
6 % (9 %) (3–21)
General morbidity (30 days) (%)
10 (31.25 %)
Mortality (30 days) (%)
0
Nosocomial infection (%) SSI (%)
3 (9.4 %) 3 (9.4 %)
Organ cavity SSI (%)
3 (9.4 %)
Incisional SSI (%)
0
Anastomotic leak (%)
3 (9.4 %)
Surgery for anastomotic leak
0
IQR interquartile range, CR-POSSUM Colorectal Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity, P-POSSUM portsmouth, POSSUM, SSI surgical site infection
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between 2 and 10 %. The postoperative morbidity and mortality rates were 31.25 (n = 10) and 0 %, respectively, both lower than the estimations. Nosocomial and surgical site infection rates were both 9.4 %. Anastomotic leakage occurred in three patients (9.4 %), all of them in group B according to Rahbari’s [27] consensus criteria. However, two patients required reintervention during the postoperative period: one was readmitted after 10 days due to small bowel obstruction, and in the other patient, the extraction and anastomosis had to be performed extracorporeally due to poor bowel preparation. The latter patient underwent surgery 24–48 h after necrosis of the descending colon on the anastomosis due to injury of the marginal artery. There was no postoperative mortality. Among the pathology variables displayed in Table 3, the distal resection margin and the circumferential margin were higher than the standards. The distal margin was 1.5 cm in only two patients, and in three patients, the circumferential margin was 2 mm. A complete TME was achieved in 30 patients (93.75 %) [22].
(transanal minimally invasive surgery, TAMIS, [30]) is that TAMIS always requires an assistant to operate the camera, a situation that hinders the surgeon’s movements in an already small space. Moreover, unlike TEO/TEM, all the equipment used in TAMIS (grasping instruments, smoke extraction device) was not specifically designed for transanal surgery and has had to be adapted to this procedure: in our experience, its assembly is not always straightforward, and air loss through the device is frequent, making it difficult to achieve a good pneumorectum. Another drawback is the length of the single port. In tumors close to the anorectal ring, a Lone Star retractor is inserted at the beginning of surgery and must then be replaced by the TAMIS device at a later stage. In TEO, the entire surgery can be performed with the same equipment from the beginning. We should mention several technical aspects in our procedure that diverge from those described by other groups [11, 12, 16, 17]: •
Discussion Our extensive experience in transanal surgery using TEM and TEO, with more than 500 patients treated so far either for rectal tumors [28] or in atypical situations [4], encouraged us to use this approach in transanal surgery for TME. In a previous study, we reported that there are few technical differences between transanal excision using TEM or TEO [29].The reason for using the TEO is the angulation of the rectoscope at 70, which provides better vision in the upper part (Fig. 5). In our view [20], the difference between using TEO/ TEM compared with single port applied to the anal canal Table 3 Descriptive analysis of pathological variables
•
•
It is important to place the patient in the modified Lloyd–Davis position, in which the right leg is positioned lower and the left leg higher, to aid the placement of the U-shaped arm which holds the rectoscope and also provides more space for the surgeon performing the transanal surgery. The pressure in the abdomen and rectum must be different. When they are similar, or when the abdominal pressure is greater, this causes a movement in the rectum, which hampers the transanal surgery. When the pressure is higher in the rectum, this effect is mitigated (we use 12 mmHg in the abdomen and 14 mmHg in the rectum). In our view, 2D high-definition cameras on wide screen are sufficient to correct transanal surgery [29].
Pathological variables
Patients (n = 32)
Distal margin (cm), median (IQR) (range)
2 cm (1) (1.5–5)
Circumferential margin (mm), median (IQR) (range)
13 mm (8) (2–35)
Mesorectal quality (Quirque) 1: Incomplete
0 (0 %)
2: Moderate
2 (6.25 %)
3: Complete
30 (93.75 %)
No lymphadenopathies median (IQR) (range)
15 (11) (7–41)
Pathological staging 0 (%)
2 (6.25 %)
I (%)
7 (21.88 %)
II (%)
10 (31.25 %)
III (%) IV (%)
12 (37.5 %) 1 (3.12 %)
IQR interquartile range
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Fig. 5 Difference in the angle of vision between TEO and TEM
•
•
•
•
Intracorporeal resection of the specimen offers certain advantages. First, it avoids the externalization of the mesocolon and mesorectum through the anal canal, which risks injury to the vessels of the mesocolon. Second, by avoiding extracorporeal resection, less colon dissection is required in many cases, avoiding the descent of the splenic flexure [31]. The removal of the specimen in a plastic bag is straightforward; no incisions in the abdomen were required in any cases [32].The disadvantage is the possible contamination due to the opening of the colon to allow entry of the anvil. However, optimal colon preparation minimizes these risks. The creation of the purse over the remaining stump using TEO means that the position of the previous resection can be adapted according to the location of the tumor (2 cm distal) and allows a longer rectal stump than in the case of extracorporeal removal. The use of a TEO rectoscope at a pressure of 8–10 mm Hg facilitates checking for anastomotic leaks and carrying out repair if defective.
The median operative time in our group (240 min), is similar to that described for the laparoscopic group in COLOR II [2] and similar to or lower than that reported by more experienced groups [16, 17, 33]. This is not a simple procedure, as the team must be well trained and skilled in both laparoscopic rectal surgery and transanal resection. Our blood loss was even lower than in the laparoscopic group in the COLOR II study [2], due to the application of a less invasive technique. In contrast to previous reports [16, 17, 33], no conversions to open surgery were required. We believe that this is one of the biggest advantages of the technique, since the conversion rates reported by expert groups in laparoscopic rectal surgery is 17 %, and as high as 25 % in patients with narrow pelvis [2]. As a
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consequence, our overall morbidity (31 %) is lower than that reported in laparoscopic groups (40 %) [2]. Rates of postoperative ileus and anastomotic leakage are similar to those described in laparoscopic surgery and other transanal surgery studies [2, 16, 17, 33]. The mean hospital stay (8 days) is comparable to those recorded with laparoscopic surgery, open surgery (9 days) [2] and other transanal surgery groups [16, 33]. The pathology variables suggest that the technique achieves satisfactory mesorectal quality in 93.75 % of cases. The median distal and circumferential margins are above the standard. The median number of nodes was 15, and half of the patients in the series underwent neoadjuvant therapy. To conclude: In this paper, we describe a series of technical innovations in transanal TME resection to further their implementation and standardization. We believe that its main indication is in patients with narrow pelvis in whom laparoscopy cannot achieve a safe distal resection and conversion is mandatory. We are unsure as yet as to whether all TME procedures in the middle third of the rectum can be performed transanally, or whether the approach should be limited to the above-mentioned conditions. At this stage in our experience with hybrid NOTES, several unknown quantities remain. The first concerns sphincter function and quality of life. The low anterior resection syndrome following conventional rectal surgery is well known [34], and we do not know whether the introduction of a single port or a 4-cm rectoscope worsens this condition. The second is oncological outcome: the application of less invasive techniques must control local recurrence and disease with the same efficiency as the results obtained with TME. These questions should be explored in prospective randomized controlled trials when larger samples are available [35]. Acknowledgments We thank the members of the multidisciplinary committee for colorectal tumors at the Parc Taulı´ University Hospital; we thank Mrs. Cristina Gomez Vigo for correcting the manuscript and Michael Maudsley for help with the English. Disclosures Xavier Serra-Aracil, Laura Mora-Lo´pez, Alex Casalots, Carles Pericay, Raul Guerrero, Salvador Navarro-Soto have no conflicts of interest or financial ties to disclose.
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and Other Interventional Techniques
DYNAMIC MANUSCRIPT
Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis Xavier Serra-Aracil1 • Laura Mora-Lo´pez1 • Alex Casalots2 • Carles Pericay3 Raul Guerrero1 • Salvador Navarro-Soto1
•
Received: 5 November 2014 / Accepted: 2 March 2015 Springer Science+Business Media New York 2015
Abstract Background Laparoscopic surgery for rectal TME achieves better patient recovery, lower morbidity, and shorter hospital stay than open surgery. However, in laparoscopic rectal surgery, the overall conversion rate is nearly 20 %. Transanal TME combined with laparoscopy, known as Hybrid NOTES, is a less invasive procedure that provides adequate solutions to some of the limitations of rectal laparoscopy. Transanal TME via TEO with technical variants (intracorporeal resection and anastomosis, TEO review of the anastomosis) attempts to standardize and simplify the procedure. Method Prospective observational study was used describe and assess the technique in terms of conversion to open surgery, overall morbidity, surgical site infection and hospital stay. The sample comprised consecutive patients diagnosed with rectal tumor less than 10 cm from the anal verge who were candidates for low anterior resection using TME (except T4). Demographic, surgical, postoperative,
Electronic supplementary material The online version of this article (doi:10.1007/s00464-015-4170-5) contains supplementary material, which is available to authorized users. & Xavier Serra-Aracil [email protected]; [email protected] 1
Coloproctology Unit, General and Digestive Surgery Service, Parc Taulı´ University Hospital, Universidad Autonoma de Barcelona, Parc Taulı´ 1, 08208 Sabadell, Barcelona, Spain
2
Pathology Service, Parc Taulı´ University Hospital, Universidad Autonoma de Barcelona, Sabadell, Barcelona, Spain
3
Medical Oncology Service, Parc Taulı´ University Hospital, Universidad Autonoma de Barcelona, Sabadell, Barcelona, Spain
and pathological variables were analyzed, as well as morbidity rates. Results From September 2012 to August 2014, 32 patients were included. The conversion rate was 0 %. Overall morbidity was 31.3 %, SSI rate was 9.4 %, and mean hospital stay was 8 days. Oncological radical criteria were achieved with pathological parameters of 94 % of complete TME and a median circumferential margin of 13 mm. Conclusion The introduction of technical variants of TEO for transanal resection can facilitate a procedure that requires extensive experience in transanal and laparoscopic surgery. Studies of sphincter function, quality of life, and long-term oncological outcome are now necessary. Keywords Transanal excision Transanal TME TEO TEM NOTES Hybrid NOTES
Introduction The expansion of laparoscopy for rectal cancer reflects the trend toward less invasive surgical techniques. Its application should maintain the principles of oncologic resection obtained with total mesorectal excision (TME) proposed by Heald [1]. The COLOR II study [2], one of the largest prospective randomized studies of open and laparoscopic surgery, found that laparoscopy achieves faster patient recovery and reduces hospital stay. However, it is not feasible in all patients: the conversion rate to open surgery is 17 %, and this figure increases in patients with narrow pelvis. Since the first description of transanal endoscopic microsurgery (TEM) by Buess [3] for local excision of rectal tumors, the application of this surgery has expanded to other rectal and pelvic diseases, which are usually treated via an abdominal approach using laparotomy or
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laparoscopy. These indications are termed ‘‘atypical,’’ as they diverge from the standard application of the technique [4]. In recent years, an adaptation of TEM using natural orifices (known as NOTES: natural translumenal orifice endoscopic surgery) has been applied to access the peritoneal cavity and perform intra-abdominal operations [5, 6]. Benefits of this technique include the maintenance of the integrity of the abdominal wall and the reduction in the rate of trauma associated with conventional surgery. The experience gained with TEM, and the emergence of groups which have demonstrated the advantages of NOTES [7–9], has opened up new possibilities for the transanal approach in rectal surgery. Leroy et al. [10] reported their experience with pure NOTES, in which TME is performed entirely via a transanal approach. However, limitations and major technical difficulties have been described. More studies assessing these innovations are currently required, but in the meantime, a number of ‘‘hybrid’’ techniques have been reported [11–14] combining laparoscopy techniques with TEM. These techniques allow the use of laparoscopy to perform critical steps such as the dissection and control of the inferior mesenteric vessels, the dissection of the splenic flexure of the colon, control of the ureter, and performing anastomosis, all drawing on the experience already obtained in laparoscopy [15]. The first report of total transanal mesorectal excision (TME) using TEM equipment was published by Sylla [5]. In recent years, the use of the single port as transanal approach has become more widespread [11, 12, 16, 17], with extracorporeal removal of the specimen and anastomosis. At our center, we have extensive experience in TEM and transanal endoscopic operation (TEO) and have designed a new technical variant of hybrid NOTES: transanal TME using TEO equipment. Resection of the specimen and anastomosis are performed intracorporeally using TEO. The anastomosis can be created at the distance from the anal verge required, and the use of TEO allows subsequent review. In this study, we describe this technique and analyze the results obtained so far.
Patients and methods Design Prospective observational study. Patients Patients diagnosed with rectal adenocarcinoma after complete colonoscopy and biopsy. Subsequently, an extension
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study was performed with endorectal ultrasound, pelvic scan, abdominal CT, and chest radiography. All patients were assessed by the multidisciplinary committee of colorectal tumors at the Parc Taulı´ University Hospital, and the therapeutic strategy was determined in accordance with international protocols [18]. Inclusion criteria Patients with rectal cancer stage cT1-2-3, cN0-1, cM0, less than 10 cm from the anal verge who were candidates for TME [1], with or without preoperative chemoradiotherapy. Exclusion criteria Patients with cT4 tumor. All patients were operated upon by surgeons at the colorectal surgery unit at our center. All signed informed consent. Patients who were candidates for neoadjuvant treatment in accordance with our center’s protocol received 50.4 Gy at a daily dose of 1.8 Gy, 5 days a week for 6 weeks concomitantly with chemotherapy comprising the oral administration of capecitabine 825 mg/m2 every 12 h or 5-fluorouracil (5-FU) via infusion, 225 mg/m2/day. Preoperative preparation All patients underwent antegrade colonic lavage, antibiotic prophylaxis (amoxicillin–clavulanic Ac 2 g/i.v. or, in the case of allergy, metronidazole 1 g/i.v and gentamicin 3–5 mg/kg/i.v.) during anesthetic induction and thromboembolic prophylaxis (enoxaparin 40 mg/administered subcutaneously) in accordance with our protocol. Surgical technique (hybrid NOTES: TEO for transanal TME) The patient is placed in the Lloyd–Davis position for the modified laparoscopic approach. A Hasson umbilical trocar is used. The remaining trocars are introduced in the right iliac fossa (12 mm) and two (5 mm) on both flanks of the abdomen. The pneumoperitoneum is created with a pressure of 12 mmHg. Conventional rectal laparoscopic surgery is performed following the planes of the TME through the lower pelvis [1]. The section of the inferior mesenteric vessels is performed at their origin and the dissection of the splenic flexure as required. After sectioning the vessels and initiating the TME via laparoscopic approach, the TEO equipment (Karl Storz GMBH, Tu¨tlingen, Germany) is introduced transanally using a 15-cm rectoscope. The pneumorectum pressure should be 14 mm Hg, slightly higher than that of the pneumoperitoneum, to prevent collapse of the rectum. The
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technique begins with the creation of a purse string, at least 1 cm distal to the direct view of the tumor (Fig. 1A, B), using standard transanal endoscopic surgery [19, 20]. Profuse lavage of the excluded rectum with saline and povidone–iodine 1 % is performed with cytolytic intent. The area of the rectum to be sectioned is dotted with the electric scalpel at a distance of 1 cm from the purse string (Fig. 1C). The dissection progresses in the posterior part until the laparoscopic TME field is reached (Fig. 1D, E). It continues laterally until the anterior face through the Denonvilliers fascia in men and the rectovaginal plane in women (Video 1). Intracorporeal resection and anastomosis After the section of the rectum and TME transanal dissection, the anvil of the circular mechanical stapler is introduced through the TEO rectoscope (Fig. 2A). In the laparoscopic field, the mesosigma is sectioned at the point where the colon section is to be performed. As described by Akamatsu [21], the colon is opened distally to the area to be sectioned, and the anvil of the circular mechanical stapler is introduced in what will be the proximal colonic part of the anastomosis. The colon is sectioned with Endo GIA (CovidiebEndo GIATM Universal Stapling System) (Fig. 2B–E) (Video 2). An endobag (Applied-Medical. Inzii 12/15 mm Retrieval System) is inserted via a 12-mm trocar, in which the TME specimen is placed and led toward the pelvis (Fig. 3A–C). From the TEO rectoscope, the
strings of the bag are recovered and pulled. The TEO rectoscope is withdrawn, and the bag containing the specimen is removed through the anus (Fig. 3D–F) (Video 3). The TEO is repositioned, and a new purse string is created on the rectal stump. The sutures of the purse are introduced into the abdominal cavity, and the laparoscopic team recovers the ends of the strings. The TEO rectoscope is withdrawn and, through the anus, the stapler is inserted and the shaft placed in the middle of the purse. From the laparoscopic field, the strings of the purse are tightened and the purse is closed around the rectal stump with a clip or slip knot. Then the two parts of the circular stapler are joined to perform the anastomosis (Fig. 4A–D). The anastomosis is checked systematically via TEO, allowing easy repair of any defect or bleeding (Fig. 4E–G) (Video 4). The surgery is completed by placing a Jackson–Pratt drain in the pelvis and a loop ileostomy in the right flank. Study variables Main outcomes: overall morbidity, nosocomial infection, surgical site infection (SSI), conversion to open surgery, and hospital stay. Demographic variables: age, sex, ASA, body mass index, distance from the anal verge, tumor height (B6–[6 cm), neoadjuvant treatment. Surgical variables: Surgical time, type of anastomosis, protection ostomy, blood loss, and dissection of splenic flexure.
Fig. 1 Total mesorectal excision via TEO
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Fig. 2 Introduction of the anvil in the proximal colon
Fig. 3 Transanal removal of the specimen in a plastic bag
Pathology: distal resection margin, radial resection margin, mesorectal quality (Quirque [22]), number of adenopathies, and tumor stage.
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Postoperative variables and 30-day morbidity: oral tolerance, 30-day morbidity, incisional SSI, organocavitary SSI, anastomotic leak, and anastomotic leak surgery.
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Fig. 4 Colorectal mechanical anastomosis and review via TEO
Postoperative monitoring, data collection, and statistical analysis Since January 2005, the morbidity of all patients admitted to both the Colorectal Unit and the Department of General and Digestive Surgery has been prospectively recorded. The assessment of adverse effects is peer-reviewed [23]. Descriptive and statistical analyses were performed (SPSS, version 20, SPSS, Inc, Chicago, IL). For the quantitative variables, means and SD were used when the distribution was considered normal; otherwise, the median, interquartile interval, and range were used. Categorical variables are reported in absolute numbers and percentages.
Results Between September 2012 and September 2014, we have operated on 32 patients using hybrid NOTES with TEO and transanal TME. Patients were enrolled consecutively in
accordance with the inclusion criteria listed above, with the exception of the first five patients who were selected according to tumor size (less than 5 cm), location in the midrectum and BMI \ 30 kg/m2. Table 1 displays patients’ demographic data. Table 2 shows the surgical and postoperative variables. The median operative time is 240 min: initially, it was between 5 and 6 h, while the most recent interventions have lasted just over 3 h. All patients underwent protective loop ileostomy, except one patient in whom a loop colostomy was performed due to poor bowel preparation. No blood transfusions were required, and no patients were converted to open surgery. Most patients (80.6 %) tolerated oral diet within 5 days. Postoperative morbidity, estimated according to the POSSUM (Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity) [24] was 48 %. The estimated postoperative mortality according to the POSSUM, P-POSSUM (Portsmouth POSSUM) [25], and CR-POSSUM (Colorectal POSSUM) scales [26] was
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Demographic variables
Patients (n = 32)
Age, years, median (IQR) (range)
68 (16) (39–88) years
Sex Male
24 (75 %)
Female
8 (25 %)
ASA II (%)
22 (68.75 %)
III (%)
10 (31.25 %)
IV (%)
0 (0 %)
BMI kg/m2
25 (6) (35–20) kg/m2
Distance from anal verge, median, IQR (range)
8 (3) (5–10) cm
Location of the rectal tumor Low rectum (B6 cm) (%)
12 (37.5 %)
Medium rectum ([6 cm) (%)
20 (62.5 %)
Neoadjuvant RCT (%)
16 (50 %)
IQR interquartile range, ASA American Society Anesthesiology, BMI Body Mass Index
Table 2 Descriptive analysis of surgical and postoperative variables
Surgical and postoperative variables
Patients (n = 32)
Surgical time, median (IQR) (range), minutes
240 (60) (165–360)
Anastomosis Manual coloanal (%)
2 (6.25 %)
Mechanical (%)
30 (93.75 %)
Defunction ostomy Ileostomy (%) Colostomy (%) Blood loss, median (IQR) (range) ml
31 (96.87 %) 1 158 (28.8) (105–230) ml
Dissection of splenic flexure
6 (18.75 %)
Rate of patients transfused
0 (0 %)
Conversion rate to open surgery
0 (0 %)
Oral tolerance \5 days
26 (81.25 %)
C5 days
6 (18.75 %)
Hospital stay, days, median (IQR) (range)
8 (7) (4–20) days
POSSUM morbidity %. Median (IQR) (range)
48 % (34 %) (15–92 %)
POSSUM mortality %, median (IQR) (range)
10 % (13 %) (3–47 %)
P-POSSUM mortality %. Median (IQR) (range)
2 % (3) (1–17 %)
CR-POSSUM mortality %, median (IQR) (range)
6 % (9 %) (3–21)
General morbidity (30 days) (%)
10 (31.25 %)
Mortality (30 days) (%)
0
Nosocomial infection (%) SSI (%)
3 (9.4 %) 3 (9.4 %)
Organ cavity SSI (%)
3 (9.4 %)
Incisional SSI (%)
0
Anastomotic leak (%)
3 (9.4 %)
Surgery for anastomotic leak
0
IQR interquartile range, CR-POSSUM Colorectal Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity, P-POSSUM portsmouth, POSSUM, SSI surgical site infection
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between 2 and 10 %. The postoperative morbidity and mortality rates were 31.25 (n = 10) and 0 %, respectively, both lower than the estimations. Nosocomial and surgical site infection rates were both 9.4 %. Anastomotic leakage occurred in three patients (9.4 %), all of them in group B according to Rahbari’s [27] consensus criteria. However, two patients required reintervention during the postoperative period: one was readmitted after 10 days due to small bowel obstruction, and in the other patient, the extraction and anastomosis had to be performed extracorporeally due to poor bowel preparation. The latter patient underwent surgery 24–48 h after necrosis of the descending colon on the anastomosis due to injury of the marginal artery. There was no postoperative mortality. Among the pathology variables displayed in Table 3, the distal resection margin and the circumferential margin were higher than the standards. The distal margin was 1.5 cm in only two patients, and in three patients, the circumferential margin was 2 mm. A complete TME was achieved in 30 patients (93.75 %) [22].
(transanal minimally invasive surgery, TAMIS, [30]) is that TAMIS always requires an assistant to operate the camera, a situation that hinders the surgeon’s movements in an already small space. Moreover, unlike TEO/TEM, all the equipment used in TAMIS (grasping instruments, smoke extraction device) was not specifically designed for transanal surgery and has had to be adapted to this procedure: in our experience, its assembly is not always straightforward, and air loss through the device is frequent, making it difficult to achieve a good pneumorectum. Another drawback is the length of the single port. In tumors close to the anorectal ring, a Lone Star retractor is inserted at the beginning of surgery and must then be replaced by the TAMIS device at a later stage. In TEO, the entire surgery can be performed with the same equipment from the beginning. We should mention several technical aspects in our procedure that diverge from those described by other groups [11, 12, 16, 17]: •
Discussion Our extensive experience in transanal surgery using TEM and TEO, with more than 500 patients treated so far either for rectal tumors [28] or in atypical situations [4], encouraged us to use this approach in transanal surgery for TME. In a previous study, we reported that there are few technical differences between transanal excision using TEM or TEO [29].The reason for using the TEO is the angulation of the rectoscope at 70, which provides better vision in the upper part (Fig. 5). In our view [20], the difference between using TEO/ TEM compared with single port applied to the anal canal Table 3 Descriptive analysis of pathological variables
•
•
It is important to place the patient in the modified Lloyd–Davis position, in which the right leg is positioned lower and the left leg higher, to aid the placement of the U-shaped arm which holds the rectoscope and also provides more space for the surgeon performing the transanal surgery. The pressure in the abdomen and rectum must be different. When they are similar, or when the abdominal pressure is greater, this causes a movement in the rectum, which hampers the transanal surgery. When the pressure is higher in the rectum, this effect is mitigated (we use 12 mmHg in the abdomen and 14 mmHg in the rectum). In our view, 2D high-definition cameras on wide screen are sufficient to correct transanal surgery [29].
Pathological variables
Patients (n = 32)
Distal margin (cm), median (IQR) (range)
2 cm (1) (1.5–5)
Circumferential margin (mm), median (IQR) (range)
13 mm (8) (2–35)
Mesorectal quality (Quirque) 1: Incomplete
0 (0 %)
2: Moderate
2 (6.25 %)
3: Complete
30 (93.75 %)
No lymphadenopathies median (IQR) (range)
15 (11) (7–41)
Pathological staging 0 (%)
2 (6.25 %)
I (%)
7 (21.88 %)
II (%)
10 (31.25 %)
III (%) IV (%)
12 (37.5 %) 1 (3.12 %)
IQR interquartile range
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Fig. 5 Difference in the angle of vision between TEO and TEM
•
•
•
•
Intracorporeal resection of the specimen offers certain advantages. First, it avoids the externalization of the mesocolon and mesorectum through the anal canal, which risks injury to the vessels of the mesocolon. Second, by avoiding extracorporeal resection, less colon dissection is required in many cases, avoiding the descent of the splenic flexure [31]. The removal of the specimen in a plastic bag is straightforward; no incisions in the abdomen were required in any cases [32].The disadvantage is the possible contamination due to the opening of the colon to allow entry of the anvil. However, optimal colon preparation minimizes these risks. The creation of the purse over the remaining stump using TEO means that the position of the previous resection can be adapted according to the location of the tumor (2 cm distal) and allows a longer rectal stump than in the case of extracorporeal removal. The use of a TEO rectoscope at a pressure of 8–10 mm Hg facilitates checking for anastomotic leaks and carrying out repair if defective.
The median operative time in our group (240 min), is similar to that described for the laparoscopic group in COLOR II [2] and similar to or lower than that reported by more experienced groups [16, 17, 33]. This is not a simple procedure, as the team must be well trained and skilled in both laparoscopic rectal surgery and transanal resection. Our blood loss was even lower than in the laparoscopic group in the COLOR II study [2], due to the application of a less invasive technique. In contrast to previous reports [16, 17, 33], no conversions to open surgery were required. We believe that this is one of the biggest advantages of the technique, since the conversion rates reported by expert groups in laparoscopic rectal surgery is 17 %, and as high as 25 % in patients with narrow pelvis [2]. As a
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consequence, our overall morbidity (31 %) is lower than that reported in laparoscopic groups (40 %) [2]. Rates of postoperative ileus and anastomotic leakage are similar to those described in laparoscopic surgery and other transanal surgery studies [2, 16, 17, 33]. The mean hospital stay (8 days) is comparable to those recorded with laparoscopic surgery, open surgery (9 days) [2] and other transanal surgery groups [16, 33]. The pathology variables suggest that the technique achieves satisfactory mesorectal quality in 93.75 % of cases. The median distal and circumferential margins are above the standard. The median number of nodes was 15, and half of the patients in the series underwent neoadjuvant therapy. To conclude: In this paper, we describe a series of technical innovations in transanal TME resection to further their implementation and standardization. We believe that its main indication is in patients with narrow pelvis in whom laparoscopy cannot achieve a safe distal resection and conversion is mandatory. We are unsure as yet as to whether all TME procedures in the middle third of the rectum can be performed transanally, or whether the approach should be limited to the above-mentioned conditions. At this stage in our experience with hybrid NOTES, several unknown quantities remain. The first concerns sphincter function and quality of life. The low anterior resection syndrome following conventional rectal surgery is well known [34], and we do not know whether the introduction of a single port or a 4-cm rectoscope worsens this condition. The second is oncological outcome: the application of less invasive techniques must control local recurrence and disease with the same efficiency as the results obtained with TME. These questions should be explored in prospective randomized controlled trials when larger samples are available [35]. Acknowledgments We thank the members of the multidisciplinary committee for colorectal tumors at the Parc Taulı´ University Hospital; we thank Mrs. Cristina Gomez Vigo for correcting the manuscript and Michael Maudsley for help with the English. Disclosures Xavier Serra-Aracil, Laura Mora-Lo´pez, Alex Casalots, Carles Pericay, Raul Guerrero, Salvador Navarro-Soto have no conflicts of interest or financial ties to disclose.
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