SURG INNOV OnlineFirst, published on December 22, 2009 as doi:10.1177/1553350609353422 Cholecystectomy by Single Trocar Access (SITRACC): The First Multicenter Study Surgical Innovation XX(X) 1–4 © The Author(s) 2009 Reprints and permission: http://www. sagepub.com/journalsPermissions.nav DOI: 10.1177/1553350609353422 http://sri.sagepub.com Marcus Vinicius Dantas de Campos Martins, PhD,1 James Skinovsky, PhD,2 Djalma Ernesto Coelho, PhD,1 Almino Ramos, PhD,3 Manoel P. Galvão Neto, PhD,3 José Rodrigues, PhD,4 Luiz de Carli, PhD,5 Leandro Totti Cavazolla, PhD,6 Josemberg Campos, PhD,7 Fábio Thuller, PhD,8 and Adriano Brunetti, PhD9 Abstract Background: The advent of endoscopic surgery has radically changed surgery worldwide.The concept of minimally invasive procedures has spread quickly, allowing less pain and more rapid recovery for patients. The authors have developed a device for a new surgical approach, the so-called single trocar access (SITRACC). This study report the first multicenter study of cholecystectomies performed with SITRACC. Methods: Between December 2008 and June 2009, 81 single trocar cholecystectomies were performed in 9 Brazilian surgery centers. Results: The average operative time was 68 minutes. In all, 10 surgeries required 1 additional trocar because of technical problems, and 3 cholecystectomies were converted to standard video laparoscopies. Conclusion: A cholecystectomy using the SITRACC method is feasible and safe. Keywords minimally invasive surgery, cholecystectomy, SITRACC Introduction The development of endoscopic surgery, which began in 1987 in the hands of the French surgeons Mouret and Perissat, represented the beginning of a new concept in surgery and allowed for surgical procedures that were minimally invasive and could reduce physiopathologic changes, cause less pain, lead to a faster recovery, and generally result in more satisfactory cosmetic outcomes. The fast and continuous technologic improvements in the optical system, as well as of the instruments used in endoscopic surgery, have permitted more and more complex operations to be performed via the minimally invasive method with worldwide acceptance. Several brand-new technologies and approaches have been developed concurrently, such as telesurgery, robotic surgery, the use of virtual reality in the surgical learning, natural orifice translumenal endoscopic surgery (NOTES), and transumbilical endoscopic surgery (TUES). Since Kalloo et al1 reported their first experience with NOTES using transgastric access in a porcine model, many clinicians have been searching for new technologies to complement this approach, as well as to determine the feasibility of NOTES in various settings. In 2005, New York City hosted members of the American Society of Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), the working group of which (Natural Orifices Surgery Consortium for Assessment and Research [NOSCAR]) produced a document titled “White Paper,” to define research guidelines, potential benefits, and priorities.2 Our group initially published our experience with NOTES in 20063 using a porcine model and concluded that some barriers need to be overcome for the adequate development of this new technology. 1 Estácio de Sá University, Rio de Janeiro, Brazil Positivo University, Curitiba, Brazil 3 Gastrobeso, São Paulo, Brazil 4 Hospital de Clínicas de Teresina, Piauí, Brazil 5 Santa Casa, Porto Alegre, Brazil 6 Hospital Mãe de Deus, Porto Alegre, Brazil 7 Universidade Federal de Pernambuco, Recife, Brazil 8 Americana, Brazil 9 Hospital Especializado, Ribeirão Preto, Brazil 2 Corresponding Author: Marcus Vinicius Dantas de Campos Martins, Medical Course of the Estácio de Sá University, Av. das Americas 505/209, Rio de Janeiro 22631000, Brazil Email: [email protected] 2 Surgical Innovation XX(X) Table 1. SITRACC Cholecystectomies Head Staff Figure 1. Trocar James Skinovsky/ Marcus V Dantas Almino Ramos/ Manuel Galvão Paulo Amaral José Rodrigues Luiz De Carli Leandro Totti Cavazolla Josemberg Campos Fábio Thuller Adriano Brunetti Total Brazilian City No. of Patients Curitiba, PR 41 São Paulo, SP 9 Salvador, BA Teresina, PI Porto Alegre, RS Porto Alegre, RS Recife, PE Americana, SP Ribeirão Preto, SP 9 7 6 5 4 4 3 2 81 Figure 3. External view of the procedure Figure 2. Working station with flexible instruments In 2007, Zhu4 published his first experience accessing the abdominal cavity via the umbilicus performing a hepatic cyst fenestration and appendectomy. This new approach was called transumbilical endoscopic surgery (TUES). Many names came later: single access surgery, single port access, single trocar access, and so on. Two years later, Zhu et al5 reported 6 cholecystectomies and 9 appendectomies using a trichannel trocar via the umbilicus. In the same year, Palanivelu et al6 reported 8 transumbilical appendectomies using a regular flexible endoscope. In 2009, Zhu et al5 published a paper describing 10 appendectomies and 26 cholecystectomies using the trichannel trocar. To further develop this approach by adding a new device to the TUES arsenal, the SITRACC device was created. The experimental study was accomplished in 2008,7 with 10 cholecystectomies being performed in pigs. This report represents the first multicenter study of cholecystectomies performed by SITRACC. This new device has Brazilian government approval for human use since early 2009. Patients and Methods In the beginning of the research process, a single trocar access system named SITRACC (Edlo Company, Porto Alegre, Brazil) was developed. This disposable new device consists of a 4-channel trocar, through which special reusable articulated instruments and a 5-mm optical device are introduced (Figures 1 and 2). Articulated graspers, scissors, hook, and clip appliers were developed especially for this approach. The surgeons, all of them with laparoscopic expertise, were chosen for training by Edlo. Training over 1 weekend was then conducted. Two groups came later and had no training. After approval of the standard protocol in the local ethics committees in all participating institutions, the study began in December 2008 and continued until June 2009. During that period, 81 single trocar access cholecystectomies were performed in 9 different surgical services in Brazil, as listed in Table 1. There were 52 women and 29 men, and the average age was 48 years (range = 17-87 years). The surgical steps were the same as for laparoscopic cholecystectomy 3 Martins et al. Figure 4. Cosmetic result 7 days following the procedure except for the use of articulated instruments. No cholangiographies were done. Figure 3 shows an external view of the procedure. Results The average surgical time was 68 minutes (range = 25-205 minutes). In all, 10 surgeries required an additional trocar placed in the right upper quadrant of the abdomen because of technical difficulties. Three cholecystectomies were converted to standard video laparoscopies, 3 of which were because of acute cholecystitis, and in 1 because the trocar placement was difficult secondary to morbid obesity. All patients were discharged from the hospital between 24 and 35 hours postoperatively, and returned for appointments within 7 to 30 days. There were no major complications; only 3 cases developed wound infections, and 8 cases developed small seromas, all of which were successfully treated with conservative measures. Figure 4 shows the cosmetic results 7 days following the procedure. Discussion In recent years, interest in performing new minimally invasive approaches has increased worldwide. The SITRACC is one new option for use in minimally invasive procedure. The advantages of the transumbilical surgical path are similar to NOTES, and include a potential faster recovery, and a scarless procedure, without the disadvantages of endolumenal surgery. The main difficulty with single trocar access surgery is the challenge of working in a single movement axis and using the instruments in parallel where the goal is to develop flexible and articulated instruments, creating triangulation, but still limited compared with standard video laparoscopy procedures. Because of the limitations with NOTES (access, orientation, infection, and visceral closure), TUES may be an excellent option to perform scarless abdominal surgery. We still do not have large comparative surgical series between similar procedures using the single access and the standard endoscopic surgery method. Some groups have also published their single incision transumbilical cholecystectomies series.8,9 Urological procedures have been also described.10 This is the first multicenter study that allows us to suggest that a cholecystectomy with a single trocar access is an excellent option and has all the advantages of a minimally invasive procedure. Prior training is desirable. Procedures by the 2 groups that did not undergo training took longer times. The TUES procedures must be viewed as part of the surgical techniques that begins with open operations, bypasses videosurgery, and in the future may be performed by NOTES. It is ultimately up to the surgeon to determine the best procedure to achieve a mix of safety, efficacy, and the best cosmetic results. Conclusion Cholecystecomy by the SITRACC approach is feasible and safe, representing a new important option in minimally invasive surgery. Because this is a new technique, SITRACC needs to be compared with conventional laparoscopy. Declaration of Conflicting Interests The authors wish to acknowledge the help rendered by ELDO, a brazilian industry which produces the SITRACC and donated the instruments for this research. Funding The authors received no financial support for the research and/ or authorship of this article. References 1. Kalloo AN, Singh VK, Jagannath SB, et al. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions. Gastrointest Endosc. 2004;60:114-117. 2. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. White paper. Gastrointest Endosc. 2006;63:199-203. 3. Martins MVDC, Coelho DE, Coelho JF, Rios M. Initial experience with natural orifices transluminal endoscopic surgery. Rev Bras Video-Sur. 2006;4:75-77. 4. Zhu JF. Scarless endoscopic surgery: NOTES or TUES. Surg Endosc. 2007;21:1898-1899. 4 5. Zhu JF, Hu H, Ma YZ, Xu MZ, Li F. Transumbilical endoscopic surgery: a preliminary clinical report. Surg Endosc. 2009;23:813-817. 6. 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