Surg Endosc DOI 10.1007/s00464-014-3779-0
and Other Interventional Techniques
NEW TECHNOLOGY
Laparoscopic cholecystectomy using a novel single-incision surgical platform through a standard 15mm trocar: initial experience and technical details Ryan C. Broderick • Pablo Omelanczuk • Cristina R. Harnsberger • Hans F. Fuchs • Martin Berducci • Jorge Nefa • Javier Nicolia • Moneer Almadani Garth R. Jacobsen • Bryan J. Sandler • Santiago Horgan
•
Received: 6 April 2014 / Accepted: 18 July 2014 Ó Springer Science+Business Media New York 2014
Abstract Objective Single-incision minimally invasive surgery has previously been associated with incisions 2.0–3.0 cm in length. We present a novel single-incision surgical platform compatible for insertion through a standard 15-mm trocar. The objective of this study is to evaluate the safety and feasibility of the platform. Methods The technology is currently a Phase I investigational device. It features articulating surgical instruments and is inserted through a multiple-use introducer. The platform’s introducer requires a standard 15-mm laparoscopic trocar. Cholecystectomy is performed through a 15-mm umbilical incision utilizing an additional epigastric
2-mm needle-port grasper for gallbladder retraction. A prospective feasibility study was performed at a singlecenter. Inclusion criteria were age 18–75 years and biliary colic. Patients were excluded if they had acute cholecystitis, dilation of the biliary tree, severe coagulopathy, BMI [ 40 kg/m2, or choledocholithiasis. Endpoints included the success rate of the platform, hospital length of stay, post-operative pain medication usage, cosmetic results, and presence of hernia. Results Six patients (5 female) with an average age of 41 years and BMI 28 kg/m2 underwent cholecystectomy with the platform. Average OR time was 91 min and umbilical incision length did not exceed 15 mm. One case
R. C. Broderick (&) C. R. Harnsberger H. F. Fuchs M. Berducci M. Almadani G. R. Jacobsen B. J. Sandler S. Horgan Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California San Diego, San Diego, CA, USA e-mail: [email protected]
P. Omelanczuk Department of Bariatric Surgery and Upper GI Surgery, Hospital Italiano de Mendoza, Mendoza, Argentina e-mail: [email protected]
C. R. Harnsberger e-mail: [email protected] H. F. Fuchs e-mail: [email protected] M. Berducci e-mail: [email protected] M. Almadani e-mail: [email protected] G. R. Jacobsen e-mail: [email protected]
H. F. Fuchs Department of Surgery, University of Cologne, Cologne, Germany J. Nefa Division of Hepatobiliary Surgery, Hospital Italiano de Mendoza, Mendoza, Argentina e-mail: [email protected] J. Nicolia Department of Surgery, Hospital Italiano de Mendoza, Mendoza, Argentina e-mail: [email protected]
B. J. Sandler e-mail: [email protected] S. Horgan e-mail: [email protected]
123
Surg Endosc
was converted to standard laparoscopy due to mechanical failure of the clip applier instrument. There were no intraoperative complications. Post-operatively, two patients developed self-resolving umbilical ecchymoses. Average length of stay was 13 h. Pain control was achieved with diclofenac for less than 7 days. At 1 month follow-up there were no complications and no umbilical hernias. Conclusions This phase I study demonstrates that singleincision cholecystectomy through a 15-mm trocar with the Fortimedix Surgical B.V. single-incision surgical platform is feasible, safe, and reproducible. Additional benefits include excellent triangulation and range of motion as well as exceptional cosmetic results. Further studies will be needed to evaluate long-term hernia rates.
Keywords Cholecystectomy Clinical papers/trials/ research Single-incision laparoscopy New technology Minimal access surgery Since Mu¨he performed the first laparoscopic cholecystectomy in 1985 followed closely by Mouret in 1987, the technique revolutionized operative procedures in the Western world [1–4]. Laparoscopic cholecystectomy is now the standard procedure for gallbladder removal due to lower morbidity and higher patient satisfaction than the open approach, and is currently the most performed operation worldwide [5]. As laparoscopy evolves, techniques are modified to create smaller incisions and minimize abdominal wall trauma, such that 2 mm ports are routine in the surgeon’s armamentarium [6]. The next logical step in the evolution of laparoscopic surgery is to decrease the number of ports, with the ultimate goal of operating through a single, minimal access port site. The first iterations required instrument crossing to achieve adequate triangulation for dissection. Multiple devices and techniques are now available for single-site access, generating interest in many surgical sub-specialties such as urology, gynecology, bariatric and gastrointestinal surgery [7]. However, widespread adoption is limited by the uncomfortable work space from instrument collisions and restricted potential for improvement in outcomes due to rigid devices [7]. Flexible instruments are also available, but current technology does not achieve adequate triangulation for optimal surgical manipulation and visualization [8, 9]. Additional limitations of current devices include large access incisions (25–30 mm) with potential for increased risk of incisional hernia, prolonged operative time, and increased risk of common bile duct injury [10, 11]. As response to criticisms of current single-site surgical devices, Fortimedix Surgical B.V. developed a novel single-incision surgical platform (from here forward referred
123
Fig. 1 Introducer
to as ‘‘the platform’’) compatible for insertion through a standard 15-mm trocar. The unique design of this technology allows introduction of two non-crossing, articulating instruments featuring improved triangulation, accuracy of tissue manipulation, and ergonomics. The objective of this study is to evaluate the safety and feasibility of the platform for use in single-site laparoscopic cholecystectomy.
Methods Study design Prior to use in humans, surgeon training on the platform was conducted by performing cholecystectomies in porcine models at the University of California San Diego’s Center for the Future of Surgery (cfs.ucsd.edu). Under IRB approval, single-site laparoscopic cholecystectomies were performed with the platform at Hospital Italiano de Mendoza, Argentina by two surgeons (SH and JN). Inclusion criteria were 18–75 years old with a diagnosis of biliary colic and no prior upper abdominal surgeries. Exclusion criteria were acute cholecystitis, biliary dilation, severe coagulopathy, BMI [ 40, choledocholithiasis, or a highrisk for general anesthesia. Endpoints evaluated were the success rate of the platform, hospital length of stay, duration and type of post-operative pain medication use, cosmetic results, and presence of a hernia. Description of the platform The platform is designed to allow multiple instruments to be manipulated within the abdominal cavity through a standard 15-mm trocar. The first major component of the platform is the introducer (Fig. 1). The main shaft of the introducer is inserted through the 15-mm trocar. Two lateral arms on the introducer provide positional support and anterior/posterior movement of flexible working
Surg Endosc
Fig. 2 Access ports through introducer
accessory instrument (i.e., 3-mm suction/irrigation device) (Fig. 2). The articulating working instruments available include hook cautery, alligator grasper, small and large curved dissectors, clip applier, and scissors (Fig. 3). These instruments are inserted through the lateral ports of the introducer and click into the instrument clamps on the lateral guide rails. The instruments have specially designed articulating segments allowing for triangulation of the end effectors without proximal instrument crossing or collision (Fig. 4). Each instrument is capable of 360-degree axial rotation as well as significant lateral, superior/inferior, and anterior/posterior mobility. The platform’s entire assembly is shown in Fig. 5. Surgical technique
Fig. 3 Available end-effectors
instruments. The introducer is held in place by a conventional table-mounted liver retractor/camera holder (Fig. 1). Once stabilized in the 15-mm trocar, devices are inserted through the introducer’s four ports. There are two lateral ports for working instruments, a superior port for a 5-mm laparoscopic camera, and an inferior port for an
The patient is placed in a supine, split-leg position, prepped, and draped in the usual fashion. A 15-mm trocar is inserted through a periumbilical incision using the Hasson technique and pneumoperitoneum is achieved. The introducer is placed through the 15-mm trocar. A 5-mm laparoscopic camera is then inserted through the superior port on the introducer to confirm safe entry into the abdomen. A 2.0–2.7 mm gallbladder grasper is inserted into the abdomen under direct visualization at a midline, sub-xiphoid position, the gallbladder is retracted cephalad (Fig. 6). Dynamic lateral retraction of the gallbladder infundibulum is performed with the alligator grasper while the cystic duct and artery are dissected free using hook cautery (or a curved dissector) as shown in Fig. 7. Dissection is continued until the cystohepatic window is visualized (Fig. 8). Within Calot’s triangle, the ‘‘critical view of safety’’ is achieved by sharp and blunt dissection. A clip applier and scissors are used for ligation and transection of the artery and duct as shown in Figs. 9 and 10. The hook cautery is used to complete dissection of the gallbladder from the liver bed (Fig. 11). The gallbladder is removed from the abdomen by removing the entire introducer as
123
Surg Endosc
Fig. 4 Range of motion and triangulation capabilities
Fig. 5 Assembled view
Fig. 6 Intraoperative view
well as trocar while firmly grasping the gallbladder. The fascia is closed under direct visualization.
cholecystectomy using the platform. Average operative time was 91 min (SD 31.7 min, Range 63–152 min) and average blood loss was 6 ml. Umbilical incision length did not exceed 15 mm in any case. One case was converted to standard laparoscopy due to mechanical failure of the clip applier instrument. Safety was not compromised and there were no intraoperative complications. Cholangiography was not used in any case.
Statistical analysis In this descriptive study, outcome variables are expressed as mean ± one standard deviation and the range is included. Results
Post-operative data (Table 2) Perioperative data (Table 1) In December 2013, six patients (5 female) with an average age of 41 years and BMI 28 kg/m2 underwent
123
Post-operatively, two patients developed self-resolving umbilical ecchymoses. Average length of stay was 13 h (10–24 h). Pain control was achieved solely with
Surg Endosc
Fig. 7 Dynamic lateral retraction with left end-effector with simultaneous dissection of cystic duct using hook cautery in right hand
Fig. 8 Blunt dissection to isolate the cystic duct and create cystohepatic window
Fig. 10 Transection of cystic duct with scissors
Fig. 11 Hook cautery dissection of gallbladder from liver bed. Note distal instrument cross-over capabilities of the platform with grasper in left hand and cautery in right hand
Discussion
Fig. 9 Ligation of cystic duct and artery with clips
diclofenac, which was discontinued within 7 days. All patients returned to work within 7 days post-operatively. At 1 month follow-up there were no complications, and no umbilical hernias. Incision at 30 days follow-up is demonstrated in Fig. 12. Further follow-up is anticipated at the 6th month and 1 year.
Since its development, single-site surgery has been applied to many surgical disciplines [7, 9, 12, 13]. Single-site cholecystectomy is a safe procedure with low complication rates, but one criticism is that a potentially higher rate of common bile duct (CBD) injury compared to conventional laparoscopy occurs [11, 14]. One theory for increased CBD injury is that tissue manipulation and exposure is difficult for single-site devices, leading to decreased identification of the ‘‘critical view of safety’’. No complications occurred in our case series, and specifically, we had no injuries to the common bile duct. The primary surgeons noted improved delicate manipulation and ergonomics in comparison to other single-site platforms, this allowed the surgeons to achieve every step necessary for a safe cholecystectomy, including identification of Calot’s triangle and the ‘‘critical view of safety’’ [15]. The technical advantages for the new technology are achieved through a standard 15-mm trocar, a first for singlesite platforms. Access for other existing single-site
123
Surg Endosc Table 1 Perioperative data
Table 2 Post-operative data
Patient
Perioperative data Age (years), gender
BMI (kg/m2)
Operative time (min)
LOS (h)
Additional ports
Pathology
1
43, F
32.7
83
11
No
Cholelithiasis
2
47, F
29.8
89
12
No
Chronic cholecystitis
3
37, M
26.5
90
24
Yes
Acute cholecystitis
4
63, F
29.4
152
12
No
Chronic cholecystitis
5
22, F
20.3
70
11
No
Cholelithiasis
6
34, F
23.2
63
10
No
Cholelithiasis
Patient
Follow-up at 1 week Notable examination findings
a
Converted to standard laparoscopy
Pain medications (days)
Return to work (days)
Notable examination findings
Hernia
1
Umbilical ecchymosis
6
7
Resolved ecchymosis
No
2
None
4
6
None
No
3a
None
4
7
None
No
4
Umbilical ecchymosis
7
7
Resolved ecchymosis
No
5
None
2
5
None
No
6
None
5
7
None
No
Fig. 12 Cosmetic result at post-operative day 30
instruments is only achieved through incisions ranging from 25–30 mm, possibly associated with a higher risk of incisional hernia [7, 13, 16, 17]. Compared to other devices, the platform also has greatly improved triangulation, range of motion, and tissue manipulation capabilities. Average operative time in our case series is comparable to previous collectives of single-site cholecystectomy [8]. One of our six cases has a significantly increased operative time compared to all other cases, which is attributed to chronic inflammation
123
Follow-up at 1 month
and clip applier malfunction resulting in a technically challenging dissection and suture ligation of the cystic artery and duct. The last two cases range from 60–70 min which is an improvement in operative time early in the learning curve, although further cases are needed to demonstrate a consistent decrease in OR time. All reasonable precautions were taken to ensure the safety of the patients for this new technology. Although technical challenges were encountered with the hook cautery and clip applier, these issues have been resolved. Safety was not compromised at any time during the trial. We report one case of conversion to conventional laparoscopy due to mechanical challenges with the clip applier. During initial procedures, a low threshold for adding ports or converting to conventional laparoscopy is important for maintaining safe and effective dissection [18, 19]. Additionally, the current extent of the platform’s ability is understood and will be improved in future iterations. Incidentally, the final postoperative pathology report for the patient converted to standard laparoscopy indicated acute cholecystitis. The patient was asymptomatic at time of the operation, had no prior signs, symptoms, or imaging consistent with acute cholecystitis, and intraoperative findings were consistent with chronic inflammation. The final pathology report likely indicates variation in pathologic diagnosis. At one-week follow-up for all patients, only minor physical findings were noted. A few patients had infraumbilical ecchymosis, possibly due to soft tissue compression by the introducer during device manipulation. All
Surg Endosc
ecchymoses self-resolved by one-month follow-up. There were no umbilical hernias at follow-up and excellent esthetics was achieved, similar to other single-site cholecystectomy series [7, 20]. Follow-up at 6 months and 1 year is planned to assess pain and hernia formation. Overall, this technology allows placement of flexible and rigid instruments, and a 5-mm camera through four working channels without instrument crossing. The instruments feature a wide range of motion and hand orientation that mirror conventional laparoscopic surgery, maintaining a comfortable surgical approach, improved tissue manipulation, and theoretically identical safety profile. Even knot tying can be performed successfully with this technology. The platform is a promising development in the evolution of single-site surgery. Due to its functionality, this technology could be applied to various aspects of general, colorectal, gynecologic, urologic, and bariatric surgery in the future. Further studies to evaluate larger-scale reproducibility, define a learning curve, and demonstrate patient safety in a large cohort for cholecystectomy are anticipated.
Conclusion This phase I study proves that single-incision cholecystectomy through a 15-mm trocar with the Fortimedix Surgical B.V. single-incision surgical platform is feasible, safe, and reproducible. Additional benefits of this technology include excellent triangulation, range of motion, and exceptional cosmetic results. Safety validation of the device in larger cohorts and other surgical fields is required and ongoing studies are planned.
Disclosures This study was made possible by funding support received from Fortimedix Surgical B.V. Drs. Ryan C Broderick, Pablo E Omelanczuk, Cristina R Harnbserger, Hans F Fuchs, Martin Berducci, Jorge Nefa, Javier Nicolia, Moneer Almadani, Garth R Jacobsen, and Bryan J Sandler have no conflicts of interest or financial ties to disclose. Dr. Santiago Horgan is an investigator, maintains stock options, and is on the advisory board for Fortimedix Surgical B.V.
References 1. Reynolds W Jr (2001) The first laparoscopic cholecystectomy. JSLS 5(1):89–94 2. Litynski GS (1996) Highlights in the History of Laparoscopy. Barbara Bernert Verlag, Frankfurt, pp 165–168 3. Mu¨he E (1992) Long-term follow-up after laparoscopic cholecystectomy. Endoscopy 24(9):754–758 4. Litwin DE, Cahan MA (2008) Laparoscopic cholecystectomy. Surg Clin North Am 88(6):1295–313, ix. doi: 10.1016/j.suc.2008. 07.005
5. Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ (2006) Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev 4:CD006231 6. Kim KW, Park JI, Nam SH (2013) The feasibility and safety of a three-port laparoscopic cholecystectomy using a 2 mm miniinstrument. Hepatogastroenterology 60(122):281–285 7. Romanelli JR, Earle DB (2009) Single-port laparoscopic surgery: an overview. Surg Endosc 23(7):1419–1427 8. Gonzalez AM, Rabaza JR, Donkor C, Romero RJ, Kosanovic R, Verdeja JC (2013) Single-incision cholecystectomy: a comparative study of standard laparoscopic, robotic, and SPIDER platforms. Surg Endosc 27(12):4524–4531 9. Haber GP, Autorino R, Laydner H, Yang B, White MA, Hillyer S, Altunrende F, Khanna R, Spana G, Wahib I, Fareed K, Stein RJ, Kaouk JH (2012) SPIDER surgical system for urologic procedures with laparoendoscopic single-site surgery: from initial laboratory experience to first clinical application. Eur Urol 61(2):415–422 10. Tranchart H, Ketoff S, Lainas P, Pourcher G, Di Giuro G, Tzanis D, Ferretti S, Dautruche A, Devaquet N, Dagher I (2013) Single incision laparoscopic cholecystectomy: for what benefit? HPB (Oxford) 15(6):433–438 11. Allemann P, Demartines N, Scha¨fer M (2014) Remains of the day: biliary complications related to single-port laparoscopic cholecystectomy. World J Gastroenterol 20(3):843–851 12. Nguyen NT, Reavis KM, Hinojosa MW, Smith BR, Stamos MJ (2009) A single-port technique for laparoscopic extended stapled appendectomy. Surg Innov. 16(1):78–81 13. Noel P, Nedelcu M, Gagner M (2014) SPIDER(Ò) sleeve gastrectomy - a new concept in single-trocar bariatric surgery: Initial experience and technical details. J Visc Surg 151(2):91–96 14. Wagner MJ, Kern H, Hapfelmeier A, Mehler J, Schoenberg MH (2013) Single-port cholecystectomy versus multi-port cholecystectomy: a prospective cohort study with 222 patients. World J Surg 37(5):991–998 15. Strasberg SM, Hertl M, Soper NJ (1995) An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg 180(1):101–125 16. Kroh M, El-Hayek K, Rosenblatt S, Chand B, Escobar P, Kaouk J, Chalikonda S (2011) First human surgery with a novel singleport robotic system: cholecystectomy using the da Vinci SingleSite platform. Surg Endosc 25(11):3566–3573 17. Jørgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T (2014) Randomized clinical trial of singleversus multi-incision laparoscopic cholecystectomy. Br J Surg 101(4):347–355 18. Overby DW, Apelgren KN, Richardson W, Fanelli R, Society of American Gastrointestinal and Endoscopic Surgeons (2010) SAGES guidelines for the clinical application of laparoscopic biliary tract surgery. Surg Endosc 24(10):2368–2386 19. Philipp SR, Miedema BW, Thaler K (2009) Single-incision laparoscopic cholecystectomy using conventional instruments: early experience in comparison with the gold standard. J Am Coll Surg 209(5):632–637 20. Van den Boezem PB, Velthuis S, Lourens HJ, Cuesta MA, Sietses C (2014) Single-incision and NOTES cholecystectomy, are there clinical or cosmetic advantages when compared to conventional laparoscopic cholecystectomy? A case-control study comparing single-incision, transvaginal, and conventional laparoscopic technique for cholecystectomy. World J Surg 38(1):25–32
123
and Other Interventional Techniques
NEW TECHNOLOGY
Laparoscopic cholecystectomy using a novel single-incision surgical platform through a standard 15mm trocar: initial experience and technical details Ryan C. Broderick • Pablo Omelanczuk • Cristina R. Harnsberger • Hans F. Fuchs • Martin Berducci • Jorge Nefa • Javier Nicolia • Moneer Almadani Garth R. Jacobsen • Bryan J. Sandler • Santiago Horgan
•
Received: 6 April 2014 / Accepted: 18 July 2014 Ó Springer Science+Business Media New York 2014
Abstract Objective Single-incision minimally invasive surgery has previously been associated with incisions 2.0–3.0 cm in length. We present a novel single-incision surgical platform compatible for insertion through a standard 15-mm trocar. The objective of this study is to evaluate the safety and feasibility of the platform. Methods The technology is currently a Phase I investigational device. It features articulating surgical instruments and is inserted through a multiple-use introducer. The platform’s introducer requires a standard 15-mm laparoscopic trocar. Cholecystectomy is performed through a 15-mm umbilical incision utilizing an additional epigastric
2-mm needle-port grasper for gallbladder retraction. A prospective feasibility study was performed at a singlecenter. Inclusion criteria were age 18–75 years and biliary colic. Patients were excluded if they had acute cholecystitis, dilation of the biliary tree, severe coagulopathy, BMI [ 40 kg/m2, or choledocholithiasis. Endpoints included the success rate of the platform, hospital length of stay, post-operative pain medication usage, cosmetic results, and presence of hernia. Results Six patients (5 female) with an average age of 41 years and BMI 28 kg/m2 underwent cholecystectomy with the platform. Average OR time was 91 min and umbilical incision length did not exceed 15 mm. One case
R. C. Broderick (&) C. R. Harnsberger H. F. Fuchs M. Berducci M. Almadani G. R. Jacobsen B. J. Sandler S. Horgan Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California San Diego, San Diego, CA, USA e-mail: [email protected]
P. Omelanczuk Department of Bariatric Surgery and Upper GI Surgery, Hospital Italiano de Mendoza, Mendoza, Argentina e-mail: [email protected]
C. R. Harnsberger e-mail: [email protected] H. F. Fuchs e-mail: [email protected] M. Berducci e-mail: [email protected] M. Almadani e-mail: [email protected] G. R. Jacobsen e-mail: [email protected]
H. F. Fuchs Department of Surgery, University of Cologne, Cologne, Germany J. Nefa Division of Hepatobiliary Surgery, Hospital Italiano de Mendoza, Mendoza, Argentina e-mail: [email protected] J. Nicolia Department of Surgery, Hospital Italiano de Mendoza, Mendoza, Argentina e-mail: [email protected]
B. J. Sandler e-mail: [email protected] S. Horgan e-mail: [email protected]
123
Surg Endosc
was converted to standard laparoscopy due to mechanical failure of the clip applier instrument. There were no intraoperative complications. Post-operatively, two patients developed self-resolving umbilical ecchymoses. Average length of stay was 13 h. Pain control was achieved with diclofenac for less than 7 days. At 1 month follow-up there were no complications and no umbilical hernias. Conclusions This phase I study demonstrates that singleincision cholecystectomy through a 15-mm trocar with the Fortimedix Surgical B.V. single-incision surgical platform is feasible, safe, and reproducible. Additional benefits include excellent triangulation and range of motion as well as exceptional cosmetic results. Further studies will be needed to evaluate long-term hernia rates.
Keywords Cholecystectomy Clinical papers/trials/ research Single-incision laparoscopy New technology Minimal access surgery Since Mu¨he performed the first laparoscopic cholecystectomy in 1985 followed closely by Mouret in 1987, the technique revolutionized operative procedures in the Western world [1–4]. Laparoscopic cholecystectomy is now the standard procedure for gallbladder removal due to lower morbidity and higher patient satisfaction than the open approach, and is currently the most performed operation worldwide [5]. As laparoscopy evolves, techniques are modified to create smaller incisions and minimize abdominal wall trauma, such that 2 mm ports are routine in the surgeon’s armamentarium [6]. The next logical step in the evolution of laparoscopic surgery is to decrease the number of ports, with the ultimate goal of operating through a single, minimal access port site. The first iterations required instrument crossing to achieve adequate triangulation for dissection. Multiple devices and techniques are now available for single-site access, generating interest in many surgical sub-specialties such as urology, gynecology, bariatric and gastrointestinal surgery [7]. However, widespread adoption is limited by the uncomfortable work space from instrument collisions and restricted potential for improvement in outcomes due to rigid devices [7]. Flexible instruments are also available, but current technology does not achieve adequate triangulation for optimal surgical manipulation and visualization [8, 9]. Additional limitations of current devices include large access incisions (25–30 mm) with potential for increased risk of incisional hernia, prolonged operative time, and increased risk of common bile duct injury [10, 11]. As response to criticisms of current single-site surgical devices, Fortimedix Surgical B.V. developed a novel single-incision surgical platform (from here forward referred
123
Fig. 1 Introducer
to as ‘‘the platform’’) compatible for insertion through a standard 15-mm trocar. The unique design of this technology allows introduction of two non-crossing, articulating instruments featuring improved triangulation, accuracy of tissue manipulation, and ergonomics. The objective of this study is to evaluate the safety and feasibility of the platform for use in single-site laparoscopic cholecystectomy.
Methods Study design Prior to use in humans, surgeon training on the platform was conducted by performing cholecystectomies in porcine models at the University of California San Diego’s Center for the Future of Surgery (cfs.ucsd.edu). Under IRB approval, single-site laparoscopic cholecystectomies were performed with the platform at Hospital Italiano de Mendoza, Argentina by two surgeons (SH and JN). Inclusion criteria were 18–75 years old with a diagnosis of biliary colic and no prior upper abdominal surgeries. Exclusion criteria were acute cholecystitis, biliary dilation, severe coagulopathy, BMI [ 40, choledocholithiasis, or a highrisk for general anesthesia. Endpoints evaluated were the success rate of the platform, hospital length of stay, duration and type of post-operative pain medication use, cosmetic results, and presence of a hernia. Description of the platform The platform is designed to allow multiple instruments to be manipulated within the abdominal cavity through a standard 15-mm trocar. The first major component of the platform is the introducer (Fig. 1). The main shaft of the introducer is inserted through the 15-mm trocar. Two lateral arms on the introducer provide positional support and anterior/posterior movement of flexible working
Surg Endosc
Fig. 2 Access ports through introducer
accessory instrument (i.e., 3-mm suction/irrigation device) (Fig. 2). The articulating working instruments available include hook cautery, alligator grasper, small and large curved dissectors, clip applier, and scissors (Fig. 3). These instruments are inserted through the lateral ports of the introducer and click into the instrument clamps on the lateral guide rails. The instruments have specially designed articulating segments allowing for triangulation of the end effectors without proximal instrument crossing or collision (Fig. 4). Each instrument is capable of 360-degree axial rotation as well as significant lateral, superior/inferior, and anterior/posterior mobility. The platform’s entire assembly is shown in Fig. 5. Surgical technique
Fig. 3 Available end-effectors
instruments. The introducer is held in place by a conventional table-mounted liver retractor/camera holder (Fig. 1). Once stabilized in the 15-mm trocar, devices are inserted through the introducer’s four ports. There are two lateral ports for working instruments, a superior port for a 5-mm laparoscopic camera, and an inferior port for an
The patient is placed in a supine, split-leg position, prepped, and draped in the usual fashion. A 15-mm trocar is inserted through a periumbilical incision using the Hasson technique and pneumoperitoneum is achieved. The introducer is placed through the 15-mm trocar. A 5-mm laparoscopic camera is then inserted through the superior port on the introducer to confirm safe entry into the abdomen. A 2.0–2.7 mm gallbladder grasper is inserted into the abdomen under direct visualization at a midline, sub-xiphoid position, the gallbladder is retracted cephalad (Fig. 6). Dynamic lateral retraction of the gallbladder infundibulum is performed with the alligator grasper while the cystic duct and artery are dissected free using hook cautery (or a curved dissector) as shown in Fig. 7. Dissection is continued until the cystohepatic window is visualized (Fig. 8). Within Calot’s triangle, the ‘‘critical view of safety’’ is achieved by sharp and blunt dissection. A clip applier and scissors are used for ligation and transection of the artery and duct as shown in Figs. 9 and 10. The hook cautery is used to complete dissection of the gallbladder from the liver bed (Fig. 11). The gallbladder is removed from the abdomen by removing the entire introducer as
123
Surg Endosc
Fig. 4 Range of motion and triangulation capabilities
Fig. 5 Assembled view
Fig. 6 Intraoperative view
well as trocar while firmly grasping the gallbladder. The fascia is closed under direct visualization.
cholecystectomy using the platform. Average operative time was 91 min (SD 31.7 min, Range 63–152 min) and average blood loss was 6 ml. Umbilical incision length did not exceed 15 mm in any case. One case was converted to standard laparoscopy due to mechanical failure of the clip applier instrument. Safety was not compromised and there were no intraoperative complications. Cholangiography was not used in any case.
Statistical analysis In this descriptive study, outcome variables are expressed as mean ± one standard deviation and the range is included. Results
Post-operative data (Table 2) Perioperative data (Table 1) In December 2013, six patients (5 female) with an average age of 41 years and BMI 28 kg/m2 underwent
123
Post-operatively, two patients developed self-resolving umbilical ecchymoses. Average length of stay was 13 h (10–24 h). Pain control was achieved solely with
Surg Endosc
Fig. 7 Dynamic lateral retraction with left end-effector with simultaneous dissection of cystic duct using hook cautery in right hand
Fig. 8 Blunt dissection to isolate the cystic duct and create cystohepatic window
Fig. 10 Transection of cystic duct with scissors
Fig. 11 Hook cautery dissection of gallbladder from liver bed. Note distal instrument cross-over capabilities of the platform with grasper in left hand and cautery in right hand
Discussion
Fig. 9 Ligation of cystic duct and artery with clips
diclofenac, which was discontinued within 7 days. All patients returned to work within 7 days post-operatively. At 1 month follow-up there were no complications, and no umbilical hernias. Incision at 30 days follow-up is demonstrated in Fig. 12. Further follow-up is anticipated at the 6th month and 1 year.
Since its development, single-site surgery has been applied to many surgical disciplines [7, 9, 12, 13]. Single-site cholecystectomy is a safe procedure with low complication rates, but one criticism is that a potentially higher rate of common bile duct (CBD) injury compared to conventional laparoscopy occurs [11, 14]. One theory for increased CBD injury is that tissue manipulation and exposure is difficult for single-site devices, leading to decreased identification of the ‘‘critical view of safety’’. No complications occurred in our case series, and specifically, we had no injuries to the common bile duct. The primary surgeons noted improved delicate manipulation and ergonomics in comparison to other single-site platforms, this allowed the surgeons to achieve every step necessary for a safe cholecystectomy, including identification of Calot’s triangle and the ‘‘critical view of safety’’ [15]. The technical advantages for the new technology are achieved through a standard 15-mm trocar, a first for singlesite platforms. Access for other existing single-site
123
Surg Endosc Table 1 Perioperative data
Table 2 Post-operative data
Patient
Perioperative data Age (years), gender
BMI (kg/m2)
Operative time (min)
LOS (h)
Additional ports
Pathology
1
43, F
32.7
83
11
No
Cholelithiasis
2
47, F
29.8
89
12
No
Chronic cholecystitis
3
37, M
26.5
90
24
Yes
Acute cholecystitis
4
63, F
29.4
152
12
No
Chronic cholecystitis
5
22, F
20.3
70
11
No
Cholelithiasis
6
34, F
23.2
63
10
No
Cholelithiasis
Patient
Follow-up at 1 week Notable examination findings
a
Converted to standard laparoscopy
Pain medications (days)
Return to work (days)
Notable examination findings
Hernia
1
Umbilical ecchymosis
6
7
Resolved ecchymosis
No
2
None
4
6
None
No
3a
None
4
7
None
No
4
Umbilical ecchymosis
7
7
Resolved ecchymosis
No
5
None
2
5
None
No
6
None
5
7
None
No
Fig. 12 Cosmetic result at post-operative day 30
instruments is only achieved through incisions ranging from 25–30 mm, possibly associated with a higher risk of incisional hernia [7, 13, 16, 17]. Compared to other devices, the platform also has greatly improved triangulation, range of motion, and tissue manipulation capabilities. Average operative time in our case series is comparable to previous collectives of single-site cholecystectomy [8]. One of our six cases has a significantly increased operative time compared to all other cases, which is attributed to chronic inflammation
123
Follow-up at 1 month
and clip applier malfunction resulting in a technically challenging dissection and suture ligation of the cystic artery and duct. The last two cases range from 60–70 min which is an improvement in operative time early in the learning curve, although further cases are needed to demonstrate a consistent decrease in OR time. All reasonable precautions were taken to ensure the safety of the patients for this new technology. Although technical challenges were encountered with the hook cautery and clip applier, these issues have been resolved. Safety was not compromised at any time during the trial. We report one case of conversion to conventional laparoscopy due to mechanical challenges with the clip applier. During initial procedures, a low threshold for adding ports or converting to conventional laparoscopy is important for maintaining safe and effective dissection [18, 19]. Additionally, the current extent of the platform’s ability is understood and will be improved in future iterations. Incidentally, the final postoperative pathology report for the patient converted to standard laparoscopy indicated acute cholecystitis. The patient was asymptomatic at time of the operation, had no prior signs, symptoms, or imaging consistent with acute cholecystitis, and intraoperative findings were consistent with chronic inflammation. The final pathology report likely indicates variation in pathologic diagnosis. At one-week follow-up for all patients, only minor physical findings were noted. A few patients had infraumbilical ecchymosis, possibly due to soft tissue compression by the introducer during device manipulation. All
Surg Endosc
ecchymoses self-resolved by one-month follow-up. There were no umbilical hernias at follow-up and excellent esthetics was achieved, similar to other single-site cholecystectomy series [7, 20]. Follow-up at 6 months and 1 year is planned to assess pain and hernia formation. Overall, this technology allows placement of flexible and rigid instruments, and a 5-mm camera through four working channels without instrument crossing. The instruments feature a wide range of motion and hand orientation that mirror conventional laparoscopic surgery, maintaining a comfortable surgical approach, improved tissue manipulation, and theoretically identical safety profile. Even knot tying can be performed successfully with this technology. The platform is a promising development in the evolution of single-site surgery. Due to its functionality, this technology could be applied to various aspects of general, colorectal, gynecologic, urologic, and bariatric surgery in the future. Further studies to evaluate larger-scale reproducibility, define a learning curve, and demonstrate patient safety in a large cohort for cholecystectomy are anticipated.
Conclusion This phase I study proves that single-incision cholecystectomy through a 15-mm trocar with the Fortimedix Surgical B.V. single-incision surgical platform is feasible, safe, and reproducible. Additional benefits of this technology include excellent triangulation, range of motion, and exceptional cosmetic results. Safety validation of the device in larger cohorts and other surgical fields is required and ongoing studies are planned.
Disclosures This study was made possible by funding support received from Fortimedix Surgical B.V. Drs. Ryan C Broderick, Pablo E Omelanczuk, Cristina R Harnbserger, Hans F Fuchs, Martin Berducci, Jorge Nefa, Javier Nicolia, Moneer Almadani, Garth R Jacobsen, and Bryan J Sandler have no conflicts of interest or financial ties to disclose. Dr. Santiago Horgan is an investigator, maintains stock options, and is on the advisory board for Fortimedix Surgical B.V.
References 1. Reynolds W Jr (2001) The first laparoscopic cholecystectomy. JSLS 5(1):89–94 2. Litynski GS (1996) Highlights in the History of Laparoscopy. Barbara Bernert Verlag, Frankfurt, pp 165–168 3. Mu¨he E (1992) Long-term follow-up after laparoscopic cholecystectomy. Endoscopy 24(9):754–758 4. Litwin DE, Cahan MA (2008) Laparoscopic cholecystectomy. Surg Clin North Am 88(6):1295–313, ix. doi: 10.1016/j.suc.2008. 07.005
5. Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ (2006) Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev 4:CD006231 6. Kim KW, Park JI, Nam SH (2013) The feasibility and safety of a three-port laparoscopic cholecystectomy using a 2 mm miniinstrument. Hepatogastroenterology 60(122):281–285 7. Romanelli JR, Earle DB (2009) Single-port laparoscopic surgery: an overview. Surg Endosc 23(7):1419–1427 8. Gonzalez AM, Rabaza JR, Donkor C, Romero RJ, Kosanovic R, Verdeja JC (2013) Single-incision cholecystectomy: a comparative study of standard laparoscopic, robotic, and SPIDER platforms. Surg Endosc 27(12):4524–4531 9. Haber GP, Autorino R, Laydner H, Yang B, White MA, Hillyer S, Altunrende F, Khanna R, Spana G, Wahib I, Fareed K, Stein RJ, Kaouk JH (2012) SPIDER surgical system for urologic procedures with laparoendoscopic single-site surgery: from initial laboratory experience to first clinical application. Eur Urol 61(2):415–422 10. Tranchart H, Ketoff S, Lainas P, Pourcher G, Di Giuro G, Tzanis D, Ferretti S, Dautruche A, Devaquet N, Dagher I (2013) Single incision laparoscopic cholecystectomy: for what benefit? HPB (Oxford) 15(6):433–438 11. Allemann P, Demartines N, Scha¨fer M (2014) Remains of the day: biliary complications related to single-port laparoscopic cholecystectomy. World J Gastroenterol 20(3):843–851 12. Nguyen NT, Reavis KM, Hinojosa MW, Smith BR, Stamos MJ (2009) A single-port technique for laparoscopic extended stapled appendectomy. Surg Innov. 16(1):78–81 13. Noel P, Nedelcu M, Gagner M (2014) SPIDER(Ò) sleeve gastrectomy - a new concept in single-trocar bariatric surgery: Initial experience and technical details. J Visc Surg 151(2):91–96 14. Wagner MJ, Kern H, Hapfelmeier A, Mehler J, Schoenberg MH (2013) Single-port cholecystectomy versus multi-port cholecystectomy: a prospective cohort study with 222 patients. World J Surg 37(5):991–998 15. Strasberg SM, Hertl M, Soper NJ (1995) An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg 180(1):101–125 16. Kroh M, El-Hayek K, Rosenblatt S, Chand B, Escobar P, Kaouk J, Chalikonda S (2011) First human surgery with a novel singleport robotic system: cholecystectomy using the da Vinci SingleSite platform. Surg Endosc 25(11):3566–3573 17. Jørgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T (2014) Randomized clinical trial of singleversus multi-incision laparoscopic cholecystectomy. Br J Surg 101(4):347–355 18. Overby DW, Apelgren KN, Richardson W, Fanelli R, Society of American Gastrointestinal and Endoscopic Surgeons (2010) SAGES guidelines for the clinical application of laparoscopic biliary tract surgery. Surg Endosc 24(10):2368–2386 19. Philipp SR, Miedema BW, Thaler K (2009) Single-incision laparoscopic cholecystectomy using conventional instruments: early experience in comparison with the gold standard. J Am Coll Surg 209(5):632–637 20. Van den Boezem PB, Velthuis S, Lourens HJ, Cuesta MA, Sietses C (2014) Single-incision and NOTES cholecystectomy, are there clinical or cosmetic advantages when compared to conventional laparoscopic cholecystectomy? A case-control study comparing single-incision, transvaginal, and conventional laparoscopic technique for cholecystectomy. World J Surg 38(1):25–32
123
