THE INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY Int J Med Robotics Comput Assist Surg (2014) Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/rcs.1609

ORIGINAL ARTICLE

Evaluation of technical feasibility and safety of Single-Site™ robotic right colectomy: three case reports

Giuseppe Spinoglio* Luca Matteo Lenti Ferruccio Ravazzoni Giampaolo Formisano Francesca Pagliardi Alessandra Marano Department of General and Oncologic Surgery, SS Antonio and Biagio Hospital, Alessandria, Italy *Correspondence to: Giuseppe Spinoglio, Department of General and Oncologic Surgery, SS Antonio and Biagio Hospital, Via Venezia 16, 15121 Alessandria, Italy. Email: [email protected]

Abstract Background Robotic Single-Site™ surgery overcomes the technical constraints of single-access laparoscopy. After performing over 130 Single-Site robotic cholecystectomies and stabilizing operative times, we applied this technology to right colon surgery. Methods We successfully completed three Single-Site robotic right colectomies (SSRRCs) using the da Vinci Si Surgical System® with a Single-Site kit (© Intuitive Surgical™) inserted through a suprapubic incision. Results Overall SSRRC operative time was 218.3 ± 75.9 min. A side-to-side anisoperistaltic anastomosis was fashioned intracorporeally (two cases) or extracorporeally (one case). All patients were discharged within 5 days. There were no complications and oncological principles were satisfied. There were no recurrences up to 12 months. Conclusions This is the first report of SSRRC with intracorporeal anastomosis using the da Vinci® Single-Site™ port inserted through a suprapubic incision. This approach is feasible and safe, with oncological outcomes potentially equivalent to those of robotic or laparoscopic multiport surgery. Copyright © 2014 John Wiley & Sons, Ltd. Keywords surgery

Single-Site™; right colectomy; robotic surgery; colon cancer; single-incision

Introduction

Accepted: 21 July 2014

Copyright © 2014 John Wiley & Sons, Ltd.

Minimally invasive techniques for the management of colon cancer have gained acceptance over the last 15 years, due to equivalent long-term oncological results combined with undoubted advantages for short-term outcomes when compared to open surgery (1–4). There has been interest in this approach since the first laparoscopic right colectomy was reported in 1991 (5,6). However, uptake for this minimally invasive technique has been slow compared to left-sided resections. Reasons for this include a more varied and complex anatomy on the right side, the need for advanced surgical skills and extensive experience and a steep learning curve (7,8).

G. Spinoglio et al.

During the last few years, there has been growing interest in minimizing the size and number of access sites in order to obtain faster patient recovery, reduce the risk of abdominal wall hernias and wound infections and improve postoperative cosmetic outcomes, all while maintaining oncological efficacy (9). This interest led to the development of natural orifice transluminal endoscopic surgery (NOTES) and single-incision laparoscopic surgery (SILS), both of which have now been applied to colon procedures. Several authors have reported on the feasibility and benefits of these minimally invasive approaches for colon surgery (10–19); however, both techniques have drawbacks (20). For NOTES, there are safety issues related to visceral access and closure and suboptimal instrumentation (21,22). Therefore, use of the NOTES approach for performing routine colon resection is far from being practical at this time. Regarding SILS, the parallel placement of the surgical instruments and the surgeon’s hands creates internal and external conflicts that have not yet been completely resolved, even after several attempts at procedural and technical modifications (23,24). The da Vinci® robotic Single-Site™ kit (da Vinci Surgical System, Intuitive Surgical, Sunnyvale, CA, USA) may solve these issues by restoring normal triangulation. The first application of this kit was for Single-Site robotic cholecystectomy (SSRC) and we have recently published our preliminary SSRC clinical series (25,26). After the completion of over 130 SSRCs, we decided to use the robotic Single-Site kit to test the feasibility and safety of this technology for right colectomy, trying to replicate the same techniques we perform with a standard laparoscopic or robotic approach. In this paper, we report our initial experience with SSRRC after 12 months of follow-up.

and one insufflation adaptor. All the Single-Site instruments are flexible and are not wristed. We used a 30° downscope, a Cadiere grasper, a pair of curved scissors, a monopolar cautery hook, a suction–irrigator and a Hem-o-lok® clip applier loaded with Hem-o-lok clips (Weck-Teleflex Medical Europe). The operative technique of SSRRC with intracorporeal anastomosis was as follows. The patient was tilted into a partial Trendelenburg supine position with a slight roll to the left. The cart was placed over the patient’s right shoulder. The assistant was positioned at the patient’s left side and the scrub nurse was at the patient’s feet. The main assistant monitor was located at the patient’s right side. The Single-Site port was introduced through a nearly 3 cm left paramedian transverse suprapubic incision and a 12 mmHg pneumoperitoneum was established (Figures 1 and 2). The last ileocolic loop was retracted laterally, with the Cadiere grasper tenting up the ileocolic vessels, and then, in order to create a window under these, the peritoneum was opened up with the cautery hook to visualize the duodenum. The ileocolic vessels were clipped and sectioned, exposing the left anterior surface of the superior mesenteric vein (SMV). Following the SMV upwards, the middle colic vessels were identified and the right branch was clipped and sectioned, utilizing cephalad traction of the transverse mesocolon created by the assistant’s laparoscopic grasper. Mobilization of the colon was performed in a medial-to-lateral direction and from bottom to top in the avascular plane between Gerota’s and Toldt’s fasciae, keeping down the right ureter and the gonadic vessels. For malignant diseases, a complete mesocolic excision (CME), according to the principles of Hohenberger and colleagues (27), was carried out, following the same standardized technique we perform during our laparoscopic and robotic multiport procedures.

Materials and methods In November 2012, three patients with a BMI < 25 kg/m2 who were affected by non-endoscopically-resectable polyps or T1–T3 lesions of the caecum/ascending colon were treated with Single-Site SSRRC by a single surgeon. Preoperative investigations included colonoscopy with biopsy and abdominal computed tomography (CT).

SSRRC with intracorporeal anastomosis: operative procedure Each procedure was carried out using the da Vinci Si Surgical System with the specialized Single-Site Port and instrumentation (Intuitive Surgical). The port has within it five lumina for: two 5 mm curved cannulae; one 5 mm accessory cannula for the assistant; one 8.5 mm cannula for the three-dimensional (3D) high-definition endoscope, Copyright © 2014 John Wiley & Sons, Ltd.

Figure 1. Intuitive Surgery Single-Site port placement Int J Med Robotics Comput Assist Surg (2014) DOI: 10.1002/rcs

Single-Site™ robotic right colectomy

Figure 4. The ileum and the transverse colon are transected with two stapler applications, including the remaining enterotomies

Figure 2. Patient and robotic cart position after Single-Site port placement and docking

The segment of transverse colon chosen for the section was skeletonized and the gastrocolic ligament and the omentum were divided. The hepatic flexure was then mobilized and the detachment of the right colon was completed by dissecting the right peritoneal groove. Finally, the segment of the terminal ileum was carefully identified and prepared. In order to perform an intracorporeal anastomosis and to be able to place the specimen into a 15 mm endobag, we inserted a 15 mm trocar on the right side of the single port, enlarging the previous skin incision. The ileum and the transverse colon were approximated side-to-side by a 3-0 absorbable monofilament stitch placed at their antimesenteric sides. An enterotomy and a colotomy were made at the antimesenteric border and the two bowel stumps were vertically aligned, with traction placed on the stay suture in order to insert a 60 mm long flexible stapler (Echelon FlexTM Endopath®, blue cartridge) and in order to perform a side-to-side anisoperistaltic anastomosis (Figure 3). Finally, the ileum and the transverse colon were mechanically transected with two stapler applications, including the remaining enterotomies, as is done in any terminalized anastomosis (Figure 4).

The specimen was inserted into an endobag and was extracted through the Pfannenstiel minilaparotomy that was the result of the combined single port and 15 mm trocar incisions. Fascia and skin were sutured in the standard fashion. Fluorescence imaging with indocyanine green (ICG), a feature that is integrated into the da Vinci system, was used to verify bowel stump perfusion before bowel transection.

Results SSRRC with CME was successfully completed in all three patients. Patients’ data are shown in Table 1. Overall SSRRC operative time, mean docking time and mean console time were 218.3 ± 75.9, 6 ± 4.8 and 180 ± 30.5 min, respectively (Table 2). In case 1 the operation took longer because we performed a moderate, unexpected adhesiolysis, due to a previous surgery. The side-to-side anisoperistaltic anastomosis was fashioned extracorporeally for the first case and intracorporeally for the remaining two cases. Fluorescence imaging with ICG was successful in verifying bowel stump perfusion in the cases where intracorporeal anastomosis was performed. No intraoperative complications were observed and no conversions or additional ports were required in any of the cases; the mean incision length was 5.6 cm. All patients had an uneventful postoperative course and the mean hospital stay was 4.6 days. There were also no complications in the 30 days following surgery. The oncological adequacy of the procedure is outlined in the final histological report, as summarized in Table 3. After 12 months, all patients were alive and disease-free; no incisional hernias were discovered.

Discussion Figure 3. A side-to-side anisoperistaltic anastomosis is fashioned by the insertion of a flexible stapler Copyright © 2014 John Wiley & Sons, Ltd.

Since the first single-incision laparoscopic right colectomy was reported in 2008 (15,16) there have been a few publications demonstrating that SILS for right colon cancer Int J Med Robotics Comput Assist Surg (2014) DOI: 10.1002/rcs

G. Spinoglio et al. Table 1. Patients’ data 2

Patient

Gender

Age (years)

ASA score

BMI (kg/m )

Indication

1 2 3

Male Female Female

61 57 93

2 2 3

25.6 20.8 18.7

Large villous adenoma of the ascending colon (severe dysplasia) Caecal carcinoma Caecal carcinoma

Table 2. Patients’ perioperative findings Patient 1 2 3

Type of anastomosis

Operative time (min)

Incision length (cm)

Time to first flatus (days)

Time to soft diet (days)

Length of stay (days)

Extracorporeal Intracorporeal Intracorporeal

300 205 150

4 4 9

1 2 2

1 1 1

4 5 5

Tumour size (cm)

Specimen length (cm)

Distal margin

No. of retrieved lymph nodes (n)

Table 3. Pathological findings Patient 1 2 3

Final histology

AJCC staging

Tubulovillous adenoma with foci of adenocarcinoma in situ Adenocarcinoma Adenocarcinoma

0

3

46

Negative

31

1 2a

2.5 7.5

27 30

Negative Negative

27 32

treatment is safe and feasible when performed on selected patients by surgeons with extensive laparoscopic experience (19,28–30). Comparative papers have reported equivalent oncological outcomes vs traditional laparoscopy (18,31). Moreover, SILS results in less postoperative pain and a shorter hospital stay than conventional laparoscopy (32). However, there are technical issues with the SILS approach, including the clashing of surgical instruments due to crowding at the access site, reduced freedom of motion due to parallel straight instruments, and a lack of triangulation. These issues have slowed the adoption of this technology and have influenced the learning curve, which has been reported to range from 10 to 36 procedures (33,34). Modifications such as the use of 30° longer laparoscopes and articulating or curved graspers and/or scissors do not completely avoid these disadvantages, and attempting a cross-handed manoeuvre makes the colonic exposure and dissection significantly harder (35). Our consistent success with Single-Site robotic cholecystectomy led us to consider using the da Vinci robotic platform and Single-Site kit as the way to overcome laparoscopic single-incision limitations for colectomy. The main robotic innovation is the use of flexible instruments, introduced through curved cannulae that cross at the level of the abdominal wall inside the port (remote centre). This increases the distance between the instrument tips, allowing each to reach the target anatomy in a convergent way so as to restore the correct triangulation. Moreover, Copyright © 2014 John Wiley & Sons, Ltd.

since the intra-abdominal instrument position is reversed (the instrument that enters the abdomen from the left reaches the operative field on the right, and vice versa), the da Vinci software automatically associates the surgeon’s hands with the ipsilateral instrument tips, restoring intuitive control. To the best of our knowledge, only two articles to date have been published regarding SSRRC for benign or malignant disease (36,37). Both groups reported the safety and feasibility of this procedure, each using a different port schema and single-access devices. Our initial experience presents some differences: 1. Single port placement. We inserted the Single-Site port in the left transverse suprapubic area in order to obtain better visualization of the SMV along its entire length and on its left side. This allowed us to perform a medial-to-lateral dissection and an adequate CME, which we routinely perform for malignant diseases. We believe that the insertion of the Single-Site port around or through the umbilicus (36,37) leads to a close-up, vertical view of the superior mesenteric vessels and to a more distal ligation of the ileocolic trunk. This makes exposing the anterior aspect of the SMV and performing CME more challenging. Our placement of the Single-Site port derives from our standardized multiport laparoscopic and robotic techniques, where the optical trocar in placed in the left iliac fossa. Int J Med Robotics Comput Assist Surg (2014) DOI: 10.1002/rcs

Single-Site™ robotic right colectomy

2. Specimen extraction. The specimen was extracted within an endobag to avoid tumoural squeezing. We chose a Pfannenstiel incision in order to obtain improved cosmesis, decreased pain and a lower risk of incisional hernias as compared to median supra- or infraumbilical laparotomy (38,39). Even in the case of larger tumours (as with patient 3 of our series), the longer incision needed for specimen extraction did not substantially affect cosmetic or functional outcomes. 3. Intracorporeal anastomosis. We utilized the advantages of the robotic Single-Site system to carry out intracorporeal anastomosis in two of three cases, since the problems of triangulation, internal and external instrument collision and anatomical visualization had been avoided. In the cases of intracorporeal anastomosis, the stapler for the bowel transection had to be introduced into the abdomen through an additional laparoscopic port. However, since the additional trocar was inserted into the same, slightly enlarged, skin incision used for specimen extraction, the theoretical principle of a single incision was preserved. Following this strategy, a standard right colectomy was performed in all three cases, with no conversions, complications or additional ports. The robotic Single-Site kit allowed for an accurate lymphadenectomy, due to the stable 3D vision, absence of tremor and lack of internal and external conflicts. All patients resumed feeding on postoperative day 1 and were discharged within 5 days. The oncological principles of CME were satisfied; the distal and proximal margins were negative and the mean number of harvested lymph nodes was 30. Moreover, at 12 months, there were no deaths, recurrences or incisional hernias. Previous reports recommended that single-incision laparoscopic right colectomy should be initially applied to select candidates (17), such as those with low BMI and small tumours. After our first two successful cases, we decided to extend our indications for SSRRC to an older female patient who was affected by a caecal malignant tumour 7.5 cm in diameter. Our success with all three cases demonstrates that the single-incision right colectomy approach can be applied to a more typical patient population, while adhering to sound oncological principles. Based on our experience, the contra-indications for the singleincision technique should be the same as for standard laparoscopic colectomy, including inability to tolerate pneumoperitoneum or presence of extensive intra-abdominal adhesions or T4 tumours. The main limitation of the da Vinci Single-Site kit is that the available instrumentation is currently quite restricted. However, with the recent introduction of the Single-Site bipolar Maryland and the Single-Site curved needle driver, together with the upcoming release of an endowristed Single-Site needle driver, this limitation could be alleviated. For this reason, we will wait to Copyright © 2014 John Wiley & Sons, Ltd.

resume our SSRRC approach until after the distribution of the new instruments. There is an ongoing randomized prospective trial (the SILVERMAN trial) designed to determine the benefits of single-incision right colectomy when compared to conventional laparoscopy; however, there is at present no such randomized trial planned to investigate the potential benefits of robot-assisted Single-Site right colectomy. Until such a trial is conducted, we strongly suggest that this approach should be applied by skilled surgeons in selected patients with low BMI (≤25 kg/m2) and T1–T3 tumours of the ciecum and ascending colon.

Conclusions To the best of our knowledge, this is the first report of SSRRC with intracorporeal anastomosis using the da Vinci Single-Site port and instrumentation. Robotic technology, by overcoming the limitations of single-incision laparoscopy, allowed us to perform standard surgery with oncological outcomes potentially equivalent to laparoscopic multiport surgery. Future studies, such as those with a larger patient population or with a multiport robotic cohort for comparison, are necessary to investigate the true benefits of singleincision procedures.

Conflict of interest Dr Giuseppe Spinoglio is a proctor and teacher for Intuitive Surgical Inc. Drs Luca Matteo Lenti, Ferruccio Ravazzoni, Giampaolo Formisano, Francesca Pagliardi and Alessandra Marano have no conflicts of interest or financial ties to disclose.

Funding No specific funding.

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Int J Med Robotics Comput Assist Surg (2014) DOI: 10.1002/rcs

Evaluation of technical feasibility and safety of Single-Site™ robotic right colectomy: three case reports.

Robotic Single-Site™ surgery overcomes the technical constraints of single-access laparoscopy. After performing over 130 Single-Site robotic cholecyst...
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