Editor-in-Chief: C. DANIEL SMITH, MD

ISSN: 1092-6429 Volume 26 Number 1 January 2016 JOURNAL OF Laparoendoscopic & Advanced Surgical Techniques Editor-in-Chief: C. DANIEL SMITH, MD Minilaparoscopy with Interchangeable, Full 5-mm End Effectors: First Human Use of a New Minimally Invasive Operating Platform www.liebertpub.com/lap S Vi ee de JL os AS co T py Pa O rt B nl in e Julietta Chang, MD, Mena Boules, MD, John Rodriguez, MD, and Matthew Kroh, MD

JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES Volume 26, Number 1, 2016 ª Mary Ann Liebert, Inc. DOI: 10.1089/lap.2015.0418 Full Reports Minilaparoscopy with Interchangeable, Full 5-mm End Effectors: First Human Use of a New Minimally Invasive Operating Platform Julietta Chang, MD, Mena Boules, MD, John Rodriguez, MD, and Matthew Kroh, MD Abstract Background: The most common paradigm in minimally invasive surgery is entry of a single trocar through separate incisions in the abdomen. However, in an effort to decrease postoperative pain and minimize scarring, alternative techniques have been described. Needlescopic surgery uses instruments that are 3 mm or less in diameter. Prior uses of needlescopic instruments have been hindered somewhat by diminished shaft strength and small end-effector size. The PercuvanceÔ (Teleflex, Wayne, PA) system uses a 2.9-mm shaft with interchangeable 5-mm end effectors in order to minimize abdominal wall trauma while maintaining the functionality of traditional laparoscopic instruments. Materials and Methods: All patients evaluated for laparoscopic surgery by two surgeons with a foregut and general surgery practice at the Cleveland Clinic (Cleveland, OH) were included in the study. Fifteen consecutive patients were enrolled in the study. Patient demographics and operative results were reviewed. Results: In March 2015, 15 patients underwent surgery using the Percuvance surgical system at the Cleveland Clinic. There was one conversion to open surgery due to extensive intraabdominal adhesions and unclear anatomy. There was one re-exploration for presumed anastomotic leak, which was negative. Operative time and length of hospital stay were similar to those of standard laparoscopic procedures. There were no deaths in this series. Subjective surgeon experience was overall positive, and functionality of the Percuvance system seemed equal to that of standard 5-mm laparoscopic instrumentation. Conclusions: This initial experience with the Percuvance system demonstrated effective exchange of 5-mm port sites for needlescopic instruments with similar handling to traditional laparoscopic instruments. This interchangeable system may allow performance similar to standard laparoscopic port instrument orientation and principles in the setting of decreased-caliber access. Introduction The tenet of minimally invasive surgery is to safely perform surgery with equivalent outcomes compared with open surgery, while minimizing the morbidity and complications associated with open laparotomy. To this end, technology is constantly evolving in an effort to provide increasingly less invasive techniques. In an effort to minimize tissue trauma, wound complications, postoperative scarring, and improve cosmesis, various approaches have been described, including the use of single-incision laparoscopic surgery and of needlescopic surgery, in comparison with standard laparoscopic trocar access. The efficacy and safety of these various techniques have been described in many single-institution reports. Needlescopic surgery was first described by Gagner and Garcia-Ruiz 1 in 1998 and is defined as surgery using instruments with a diameter equal to or less than 3 mm. Since then, different needlescopic devices have been developed. However, while reducing incision size, the use of needlescopic instruments has been limited by the required downsizing of the end effector and the diminished shaft strength and length. To address this, the PercuvanceÔ percutaneous surgical system (Teleflex, Wayne, PA) has been developed with instruments having a 2.9-mm shaft that are inserted percutaneously through the skin, with full, standard 5-mm end Digestive Diseases Institute, Cleveland Clinic Foundation, Cleveland, Ohio. 1

2 CHANG ET AL. effectors that are attached to the shaft end through a separate 5-mm or larger port. This report aims to describe the first human series of patients undergoing surgery performed with the Percuvance needlescopic instruments in a spectrum of general surgical applications. Materials and Methods Study protocol Consecutive patients were enrolled to undergo laparoscopic surgery using the Percuvance system. All procedures were performed by two attending surgeons ( M.K. and J.R.). Both are experienced minimally invasive surgeons. All patients evaluated for laparoscopic surgery in a foregut, bariatric, and general surgical practice were included in the study. The only exclusion criterion was contraindication to laparoscopy. Patients were not excluded on basis of body mass index or complexity of planned operative procedure, including previous surgery. Patient demographics collected included patient age, sex, American Society of Anesthesiologists score, body mass index, and preoperative diagnosis. The data analyzed included total operative time, the total number of access sites used, the number of percutaneous access sites, conversion rate to open laparotomy, any complications of the procedure, and unique, unplanned applications of this technology. Novel operative instrumentation The Percuvance system uses a 2.9-mm disposable shaft with reusable, interchangeable end effectors and a ratcheted reusable handle (Fig. 1). The shaft is inserted into the abdomen under direct visualization with a Veress needle tip. Once the shaft is intraabdominal, the end is extracorporealized through an adjacent port that is 5 mm or larger. The Veress needle tip is unscrewed and exchanged for an end effector of choice by hand. Instruments that are currently available include atraumatic grasper, traumatic grasper, Maryland dissector, and scissors. The instruments can be exchanged as many times as necessary; this requires extracorporealizing the shaft through an adjacent 5-mm port for exchange (Fig. 2). Upon completion of the case, the end effector is removed, and the shaft is withdrawn from the abdominal wall. Operative technique Entry into the abdomen was gained through the optical trocar. After insufflation of the abdomen, an initial diagnostic laparoscopy was performed in all cases. Additional access ports including the Percuvance instrument were then inserted under direct visualization, and the operation proceeded in a typical manner as appropriate for the planned operation. The fascia was closed with 0-polyglactin 910 (Vicryl Ò ; Ethicon, Somerville, NJ) with a laparoscopic suture passer if the defect was 10 mm or greater. The skin was closed with 4-0 poliglecaprone 25 (Monocryl Ò ; Ethicon) on access sites that were 5 mm or larger. The percutaneous access sites were closed without suture using adhesive and Steri-StripsÔ (3M, St. Paul, MN) only. Postoperative care Patients were discharged after meeting standard criteria, including adequate pain control and resumption of oral intake. They were followed up in the clinic 2 weeks after surgery and per existing protocols depending on surgery type. Data were collected prospectively during each case, entered into a database, and summarized using descriptive statistics. FIG. 1. The Percuvance system. Courtesy of Teleflex.

MINILAPAROSCOPY 3 FIG. 2. Extracorporeal instrument exchange. (A) Extracorporealized Veress needle tip. (B) Attaching the 5-mm end effector. (C) End effector engaged and ready to use. Results In March 2015, 15 patients underwent surgery using the Percuvance surgical system at the Cleveland Clinic; procedures included five laparoscopic jejunostomies, two laparoscopic sleeve gastrectomies, one Roux-en-Y gastric bypass, one gastric electric stimulator placement, one gastric electric stimulator explant, one ventroperitoneal shunt revision, one laparoscopic cholecystectomy, one laparoscopic paraesophageal hernia repair, one laparoscopic duodenojejunostomy, and one laparoscopic ventral hernia repair with mesh. The patient demographics are summarized in Table 1, and the intraoperative details are listed in Table 2. We did not need to modify our standard operative technique during use of Percuvance instruments, and operative times were similar to those when using traditional laparoscopic instruments, as was expected length of stay. There was one conversion to open incision laparotomy during a complex revisional procedure for a feeding jejunostomy placement related to dense adhesions. There was one postoperative complication with a presumed anastomotic leak following laparoscopic duodenojejunostomy requiring exploratory laparotomy and washout. Findings at that time did not demonstrate anastomotic leak. There were no deaths in our series. There were no instrument malfunctions or specific instrument-related complications in our series. Postoperatively, the scarring following Percuvance use was minimal, and there were no wound-related complications with the Percuvance system or other trocar sites. Figure 3 is an intraoperative photograph demonstrating the difference in skin incision size among 10-mm, 5-mm, and Percuvance access sites immediately prior to closure. Discussion There is a continued interest in the development of less invasive technology in general surgery. The most common paradigm in minimally invasive surgery is entry of a single trocar through separate incisions in the abdomen. However, in an effort to decrease postoperative pain and minimize scarring, alternative techniques have been described. Innovations have ranged from natural orifice surgery to singleincision surgery. Well-known limitations to these include reduced surgeon ergonomics, difficulty in instrument triangulation, and decreased quality of optics that may be encountered. Single-access surgery minimizes the number of incisions but results in worsened ergonomics with unclear Patient Age (years) Table 1. Patient Demographics Sex BMI (kg/m 2 ) ASA score Preoperative diagnosis 1 23 F 22 3 Failure to thrive 2 32 F 21 4 Gastroparesis 3 62 F 41 2 Morbid obesity 4 37 F 12 3 Intestinal dysmotility 5 68 F 38 3 Morbid obesity 6 43 F 67 3 Redundant intraabdominal ventriculoperitoneal shunt catheter 7 57 F 47 3 Morbid obesity 8 28 F 36 3 Gastroparesis 9 55 M 24 3 Failure to thrive 10 22 F 16 3 Superior mesenteric artery syndrome 11 59 F 20 3 Gastroparesis, failure to thrive 12 23 F 33 2 Gastroesophageal reflux disease 13 57 F 33 3 Gastroparesis 14 68 M 26 3 Ventral hernia after prostatectomy 15 58 F 35 3 Symptomatic cholelithiasis ASA, American Society of Anesthesiologists; BMI, body mass index; F, female; M, male.

4 CHANG ET AL. Patient Operation Table 2. Operative Data OR time (minutes) Total access site number Percuvance access site number 1 Laparoscopic jejunostomy 48 4 2 2 Laparoscopic gastric stimulator placement 85 4 2 3 Laparoscopic sleeve gastrectomy 154 5 1 4 Laparoscopic jejunostomy 76 5 3 5 Laparoscopic Roux-en-Y gastric bypass 130 5 2 6 VPS revision 13 3 2 7 Laparoscopic sleeve gastrectomy 169 4 2 8 Laparoscopic jejunostomy 73 4 2 9 Laparoscopic jejunostomy 125 4 2 10 Laparoscopic duodenojejunostomy 91 5 2 11 Laparoscopic converted to open jejunostomy 190 3 1 12 Laparoscopic PEHR, Nissen fundoplication 95 5 2 13 Laparoscopic GES removal, partial gastrectomy 204 4 2 14 Laparoscopic ventral hernia repair with mesh 72 4 2 15 Laparoscopic cholecystectomy 50 4 1 GES, gastric electric stimulator; OR, operating room; PEHR, paraesophageal hernia repair; VPS, ventroperitoneal shunt. effects on postoperative pain and rates of hernia incidence, 2 and some have shown that there is increased cosmesis at the expense of increased hernia occurrence. 3 Furthermore, these technologies are associated with learning curves. 4 Needlescopic surgery, first described by Gagner and Garcia-Ruiz 1 in 1998, is defined by the use of instruments 3mmorlessindiameterinanefforttodecreaseaccessrelated tissue trauma, including pain, hernia, and wound infection. In this initial 60-patient series undergoing laparoscopic cholecystectomy, they found that the operating time was longer for the needlescopic group but that postoperative analgesia use was reduced. The use of needlescopic instruments in a similar configuration as standard laparoscopy obviates the need to relearn how to perform a procedure, eliminating the steep learning curve associated with other proposed technologies. Patient positioning and surgeon ergonomics are identical to those for standard laparoscopy. The use of needlescopic instruments has been previously demonstrated to be feasible in a range of laparoscopic surgeries, including cholecystectomy, appendectomy, splenectomy, Nissen fundoplication, thyroidectomy, FIG. 3. Intraoperative demonstration of skin incision sizes using the Percuvance system, a 5-mm port, and a 10-mm port. axillary lymph node dissections, and video-assisted thoracoscopic surgery. 5,6 Potential advantages of needlescopic instruments include decreased abdominal wall trauma and risk of future herniation, decreased risk of wound infection with a smaller skin incision, and a virtually invisible scar, improving postoperative cosmesis. 6,7 Needlescopic surgery has been demonstrated to have decreased sympathetic nervous system activation compared with traditional laparoscopy and likely contributes to decreased narcotic requirements in the postoperative period. 8 Needlescopic instruments have also been described as a valuable adjunct to single-incision laparoscopic surgery, and their use has been shown to shorten operative times and minimize portsite abdominal wall trauma. 6 However, the use of such needlescopic instruments has been limited in application by the small size of the instrument head (less than 3 mm), lack of strength of the instruments themselves in tissue handling, and limited instrument heads available for use. 6 The smaller end effector can have an increased risk of tissue trauma due to the pointed head required for insertion. 6 The use of 3-mm shafts with 5-mm end effectors has been described in the past, 9 but their widespread adoption may have been limited by unclear indications for their use as well as a learning curve associated with endeffector exchange. In our experience, we found that the Percuvance system was a comparable alternative to a 5-mm port with similar performance to a traditional laparoscopic instrument. Extracorporealizing the 2.9-mm shaft through a separate 5-mm or larger trocar was technically simple, as was the actual exchange of different end effectors. The needlescopic tips (and other instrument tips) are screwed on, and this entire process takes place outside of the abdominal cavity. We did not experience any disengagement of instrument tips during this study, nor did we experience any laxity or looseness of the tip that would make us concerned about the durability of the needlescopic tip. When the shafts were removed from the abdominal wall, we experienced no loss of pneumoperitoneum; this would potentially allow the surgeon to resite the Percuvance instruments multiple times without opening new instruments or needing to address loss of pneumoperitoneum.

MINILAPAROSCOPY 5 Our series had only one conversion from laparoscopic to open surgery, and this was not attributable to the Percuvance instruments. Rather, it was a re-operative case with unclear anatomy requiring conversion to open. However, we were able to complete a significant portion of the initial dissection laparoscopically, facilitating the open portion of the procedure. Prior trials have demonstrated that the conversion rate from laparoscopic to open cholecystectomy is similar in needlescopic versus conventional laparoscopic surgery. 10 Needlescopic surgery has been demonstrated to improve cosmesis and decrease postoperative pain. We believe that widespread adoption has been somewhat limited by unclear indications for their use. In our series, we used the Percuvance in an unselected cohort of patients in exchange for the traditional 5-mm port(s). Due to the limited variety of end effectors currently available, the needlescopic instruments were used primarily for grasping (e.g., running the bowel) or retracting (as in the lateral port sites during a sleeve gastrectomy and cholecystectomy). However, it should be noted that both surgeons were able to successfully use the grasping instruments for nontraditional use, including intracorporeal suturing when the percutaneous site offered a better approach. Limitations of this study are that it is a retrospective review with a small sample size and limited patient follow-up. However, the aim of our article is to demonstrate feasibility and flexibility of using a novel needlescopic instrument device. As our experience with the technology grows, the utility as well as long-term outcomes may become more evident. As the variety of end effectors grows, the flexibility in exchanging the percutaneous instruments for 5-mm port sites should expand. Conclusions This initial experience with the Percuvance system demonstrated effective exchange of 5-mm port sites for needlescopic instruments with similar handling to traditional laparoscopic instruments. The Percuvance system may provide a viable option in minimizing the number of larger incisions while providing a more durable end effector compared with traditional needlescopic instruments and may allow maintenance of basic, safe laparoscopic principles in the setting of decreased caliber access. Disclosure Statement M.K. has served as a consultant to Teleflex Medical. J.C., M.B., and J.R. declare no competing financial interests exist. J.C. is responsible for the writing of the manuscript and data entry. M.B. is responsible of revision of the manuscript and data entry. J.R. and M.K. are responsible for final review and for the study concept. References 1. Gagner M, Garcia-Ruiz A. Technical aspects of minimally invasive abdominal surgery performed with needlescopic instruments. Surg Laparosc Endosc 1998;8:171 179. 2. Bencsath KP, Falk G, Morris-Stiff G, Kroh M, Walsh RM, Chalikonda S. Single-incision laparoscopic cholecystectomy: Do patients care? J Gastrointest Surg 2012;16:535 539. 3. Marks JM, Phillips MS, Tacchino R, Roberts K, Onders R, DeNoto G, Gecelter G, Rubach E, Rivas H, Islam A, Soper N, Paraskeva P, Rosemurgy A, Ross S, Shah S. Singleincision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of significantly higher hernia rates: 1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy. J Am Coll Surg 2013;216: 1037 1047. 4. Kroh M, El-Hayek K, Rosenblatt S, Chand B, Escobar P, Kaouk J, Chalikonda S. First human surgery with a novel single-port robotic system: Cholecystectomy using the da Vinci Single-Site platform. Surg Endosc 2011;25:3566 3573. 5. Krpata DM, Ponsky TA. Needlescopic surgery: What s in the toolbox? Surg Endosc 2013;27:1040 1044. 6. Tagaya N, Abe A, Kubota K. Needlescopic surgery for liver, gallbladder and spleen diseases. J Hepatobiliary Pancreat Sci 2011;18:516 524. 7. Tagaya N, Kubota K. Reevaluation of needlescopic surgery. Surg Endosc 2012;26:137 143. 8. Schmidt J, Sparenbert C, et al. Sympathetic nervous system activity during laparoscopic and needlescopioc cholecystectomy: A prospective randomized study. Surg Endosc 2002;16: 476 480. 9. David G, Boni L, Rausei S, Cassinotti E, Dionigi G, Rovera F, Spampatti S, Colombo EM, Dionigi R. Use of 3mm percutaneous instruments with 5mm end effectors during different laparoscopic procedures. Int J Surg 2013;11:561 563. 10. Novitsky Y, Kercher K, Czerniach DR, Kaban GK, Khera S, Gallagher-Dorval KA, Callery MP, Litwin DE, Kelly JJ. Advantages of mini-laparoscopic vs conventional laparoscopic cholecystectomy: Results of a prospective randomized trial. Arch Surg 2005;140:1178 1183. Address correspondence to: Julietta Chang, MD Digestive Diseases Institute Cleveland Clinic Foundation 9500 Euclid Avenue, A100 Cleveland, OH 44195 E-mail: juliettac@gmail.com

MLIB-000387