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Surgical Technology International XXVII contains 41 peer-reviewed articles featuring the latest advances in surgical techniques and technologies.
Nov, 2015 - ISSN:1090-3941
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Surgical Overview
“Big Operations Using Mini Instruments” The Evolution of Mini Laparoscopy in the Surgical Realm
Jay A. Redan, MD, FACS, Medical Director, Minimally Invasive General Surgery, Florida Hospital Celebration Health, Celebration, Florida, Professor of Surgery, University of Central Florida College of Medicine, Orlando, Florida, , Ashley-Rose Humphries, BA, Medical Student, University of Central Florida College of Medicine, Orlando, Florida, , Brianne Farmer, MS, Medical Student, University of Central Florida College of Medicine, Orlando, Florida, , Eduardo Moreno Paquentin, MD, FACS, Associate Professor of Surgery, Centro Medico ABC Santa Fe, Mexico City, Mexico, , Charles H. Koh, MD, FRCOG, FACOG, Attending Staff, Columbia Hospital, St. Mary's Hospital, Milwaukee, WI, Attending Staff, Mount Alvernia Hospital, Queen Elizabeth Hospital, Singapore, , Dr. Maurice K. Chung, RPh, MD, FACOG, FPMRS, FACS, ACGE., Clinical Professor, Department of Obstetrics and Gynecology , University of Toledo School of Medicine, Toledo, Ohio, Chairman, Department of Surgery, Lima Memorial Hospital, Lima, Ohio, Gustavo Stringel, MD, MBA, Professor of Surgery and Pediatrics, New York Medical College, Surgeon in Chief, Maria Fareri Children’s Hospital, Valhalla, New York, , Steven D. McCarus, MD, FACOG, Assistant Professor, Department of Obstetrics and Gynecology, University of Central Florida, Chief Division of Gynecologic Surgery, Florida Hospital Celebration Health, Orlando, Florida, , Gustavo Carvalho, MD, PhD, MSc, MBA, Associate Professor of Surgery, University of Pernambuco, Attending Surgeon, Department of Surgery, Hospital Universitário Oswaldo Cruz, Recife, Brazil, , Roberto Gallardo Diaz, MD, Staff Surgeon, Sanatorio El Pilar in Guatemala City, Head , Mini Invasive Surgical Group of Guatemala, Guatemala City, Guatemala, , Phillip P. Shadduck, MD, FACS, Assistant Consulting Professor of Surgery, Duke University, Vice Chair of Surgery, Duke Regional Hospital, Chief of General Surgery, TOA Surgical Specialists, Vice Chief of Staff, North Carolina Specialty Hospital, Durham, North Carolina
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Laparoscopy using miniature (2–3.5 mm) instruments was introduced in the late 1980s and early 1990s. Though mini laparoscopy (Mini) created new opportunities for surgical diagnosis and therapy, the limitations of early instruments inhibited widespread adoption. This is no longer the case. Mini is enjoying a renaissance, due to several factors: the maturation of minimally invasive surgery (MIS), the failure of laparoendoscopic single-site surgery (LESS) and natural orifice transluminal endoscopic surgery (NOTES) platforms to achieve early expectations, and the recent significant improvements in Mini instrument functionality and durability. As a result, Mini is being increasingly applied to pediatric and adult procedures across specialties. To assess the current status of Mini laparoscopy, the Society of Laparoendoscopic Surgeons (SLS) and the Florida Hospital Nicholson Center convened an international symposium in February 2015. This report shares highlights from that symposium, “Big Operations Using Mini Instruments.”
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Systematic Review of Randomized Controlled Trials Comparing Manual Compression to Vascular Closure Devices for Diagnostic and Therapeutic Arterial Procedures
Tiffany Cox, MD, Fellow, Minimally Invasive Surgery , Laurel Blair, MD, Fellow, Minimally Invasive Surgery, Ciara Huntington, MD, Resident, General Surgery , Amy Lincourt, PhD, Research Group Director, Ronald Sing, DO , Attending, Surgical Critical Care, B. Todd Heniford, MD, Chief, Division of Gastrointestinal and Minimally Invasive Surgery, Carolinas Laparoscopic and Advanced Surgery Program, Charlotte, North Carolina
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Purpose: A multitude of vascular closure devices (VCDs) are currently on the market for femoral arteriotomy closure after diagnostic and interventional angiography. Randomized, controlled trials (RCTs) comparing these devices to manual compression (MC) and their effect on time to hemostasis, time to ambulation, time to discharge, and immediate as well as long term complications have been studied. A systematic and through review of these evaluations and outcomes has not previously been performed.
Materials and methods: A systematic review was completed to include all available RCTs comparing vascular closure device use to manual compression. Devices meeting inclusion criteria were as follows: VasoSeal® (Datascope Corporation, Montvale, NJ), AngioSeal™ (Sherwood-Davis & Geck, St Louis, MO/St Jude Medical, St Paul, MN), ProGlide® (Abbott Vascular, Abbott Park, IL), ProStar® (Abbot Vascular, Menlo Park, CA), StarClose SE® (Abbott Vascular, Redwood City, CA), ExoSeal™ (Cordis, Warren, NJ), Boomerang™ Wire (Cardiva Medical, Mountainview, CA), FemoSeal™ (St Jude Medical Systems, Uppsala, Sweden), EVS™ (expanded vascular stapling, Angiolink Co, Taunton, MA), X-PRESS™ (X-Site Medical, Blue Bell, PA), Duett™ (Vascular Solutions, Minneapolis, MN), EpiClose-T® (CardioDex Ltd., Tirat Ha Carmel, Israel), and FISH™ (femoral introducer sheath and hemostasis, FISH Device, Bloomington, IN). Vascular closure devices were compared both to manual compression and across all devices used for the following outcomes: time to hemostasis, time to ambulation, time to discharge, and outcomes such as bleeding, hematoma, pseudoaneurysm, limb ischemia, and overall major and minor complications, as well as impact on quality of life, cost analysis, and trends over time. Both diagnostic and interventional procedures were included.
Results: PUBMED and MEDLINE searches were carried out for VCDs identifying 1,363 articles. Manuscripts that included manual compression in the study numbered 176. Of these, 34 randomized controlled trials were included. Studies that met inclusion criteria were published from 1992–2015 and described a total of 14,401 patients, 5,659 patients undergoing MC, and 8,742 patients undergoing VCD placement. Overall, the rate of procedural success for VCD patients was 95.7%. The highest rate of unsuccessful device deployment was seen in the ExoSeal™ subset, which averaged 37.9% failure. The overall median time to hemostasis for manual compression was 22.9 minutes compared to VCDs at 5.95 minutes; FemoSeal™ had the shortest median time to hemostasis of 0.75 minutes. When comparing the type of procedure and its median time to hemostasis, MC versus VCD was 17 minutes versus 3.7 minutes for diagnostic procedures and 29.1 minutes versus 7.6 minutes for interventional procedures with similar sheath sizes at 6 and 7 French, respectively. Similarly, median time to ambulation for MC was eight hours compared to 3.5 hours for patients who received a VCD. Median time to discharge was similar at 1.6 days. However, time to discharge has diminished over the last decade comparing MC to VCD, with a median time to discharge of 3.1 versus 2.2 days compared to current trends at 0.8 versus 0.5 days, respectively. The overall rates of complications were similar between MC at 13.1% versus VCDs at 12.2% but varied significantly according to the VCD that was selected. For patients randomized to the vascular closure device who had undergone prior angioplasty, 94.4% of these patients preferred the use of VCD if a further angioplasty were to be performed in the future. A 13% reduction in overall costs with VCD was demonstrated due to earlier discharge and less required time with physician and nursing staff.
Conclusion: Overall, the review of 34 RCTs demonstrates the utility of VCDs has shortened time to hemostasis, ambulation, and discharge compared to patients receiving MC. Over the last decade, with emphasis on and implementation of same-day procedures, use of VCDs has resulted in a reduction in time to discharge to half a day and a significant decrease in cost. Overall complication rates are similar, but vary between different devices on the market. Better short-term quality of life has also been described with the use of VCDs compared to MC. Further clinical and financial improvements may be found as newer technological advances of VCDs become available.
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An In Vivo Comparison of Hemostatic Gelatin Matrix Products in a Porcine Spleen Biopsy-punch Model
Richard W. Hutchinson, DVM, PhD, Research Fellow, Stephanie Werrlein, SRA, RLATG, CVT, Associate Scientist, Douglas B. Johns, PhD, Director Research & Development, Gary Zhang, PhD, Engineering Fellow, Jeffrey W. Clymer, PhD, Biostatistician, Richard Kocharian, MD, PhD, Franchise Medical Director, Ethicon Inc., Somerville, New Jersey
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Flowable gelatin matrix products have established themselves as effective, easy-to-use hemostatic agents useful in a variety of surgical situations. A recently reformulated gelatin matrix, Surgiflo® (Ethicon Inc., Somerville, NJ), can be prepared quickly and provides consistent flow over an 8-hr. period. No in vivo studies have yet been reported comparing hemostasis with the new Surgiflo to other currently marketed flowable gelatin matrix products. This study was conducted to determine whether Surgiflo in actual use has hemostatic qualities different from another commercial gelatin matrix. An in vivo model based on porcine spleen biopsy punch-induced bleeding was used to compare Surgiflo and Floseal™ (Baxter Healthcare Corporation, Hayward, CA), both with thrombin. Time required to achieve hemostasis and proportion of sites achieving hemostasis within 30 s were determined for both hemostatic agents and a control of saline-soaked gauze. Results were stratified by the degree of initial bleeding (mild, moderate, severe). Hemostasis was achieved within 3 minutes at all sites for both test products regardless of level of initial bleeding, and control sites continued bleeding past 10 minutes. There were no statistically significant differences between Surgiflo and Floseal for either mean time to hemostasis or proportion of sites hemostatic within 30 s. In this realistic in vivo model both gelatin matrix products were effective, and there were no significant differences observed in hemostatic efficacy between Surgiflo and Floseal. Other factors, such as ease of preparation and application, in-use stability, and economic considerations may affect a surgeon’s decision in selection of a desirable hemostatic product.
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Prospective Clinical Study to Evaluate Clinical Performance of a Powered , Surgical Stapler in Video-assisted , Thoracoscopic Lung Resections
Peter B Licht, MD, PhD, Professor of Surgery, Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark, Goran Ribaric, MD, Medical, Regional Safety Officer, Johnson & Johnson, Hamburg, Germany, Traves Crabtree, MD, Associate Professor of Surgery, Department of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri, Michael Lanuti, MD, Director, Thoracic Oncology, Division of Thoracic Surgery, Massachusetts General Hospital, Boston, Massachusetts, Laureano Molins, MD, PhD, FETCS, Head of Thoracic Surgery, Department of Thoracic Surgery, University of Barcelona, Barcelona, Spain, Susan Knippenberg, MBA, Senior Project Manager, Ethicon, Cincinnati, Ohio, Michael Schwiers, MS, Principal Statistician, Ethicon, Cincinnati, Ohio, Andrew Yoo, MD, Director of Epidemiology, Johnson & Johnson, New Brunswick, New Jersey
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Video-assisted thoracic surgery (VATS) research often focuses on postoperative air leak, with special consideration for prolonged air leak. There is limited clinical data regarding how stapling devices might affect performance and postoperative outcomes, including air leak. This prospective research evaluates intraoperative and postoperative data associated with VATS, using a new surgical stapling device, in two different geographic regions (the U.S. and Europe). A total of 226 subjects across 10 institutions were enrolled in this study. The primary endpoint was occurrence and duration of postoperative air leaks, including prolonged air leak. Additional data collected included intraoperative details and postoperative outcomes. Prolonged air leak occurred in 22 subjects (10.3%) across procedures (152 lobectomies, 63 wedge resections, and 11 occurrences of wedge resection plus lobectomy). There were no significant differences in occurrence or duration of PAL between the U.S. and Europe. Regional differences were observed for intraoperative leak testing and cartridge selection relative to tissue type. Despite differences in surgical technique between continents, no major or significant difference in air leak or other clinical outcome was detected. Additional research is needed to characterize optimal cartridge selection to tissue properties and how these may potentially impact clinical outcomes.
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The Use of Haemostatic Agents and Sealants for the Prevention of Lymphocele After Urological Surgery: A Review of the Literature
Michele Marchioni, MD, Urology Resident, Manuela Ingrosso, MD, Urology Resident, Piergustavo De Francesco, MD, Urology Resident, Giulia Primiceri, MD, Urology Resident, Rossella Manco, MD, Urology Resident, Raffaele Lanfranco Tenaglia, MD, Urology Professor, Biomedical Science, Università degli Studi “G.D’Annunzio”, Chieti-Pescara, Chieti, Italy
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Background: Despite the continuous technological innovation in urological surgery procedures, lymphocele represents one of the major and more frequent complications both in tumour and transplant surgery. Haemostatic agents have been used hypothesizing a beneficial effect on the prevention of lymphoceles. We aimed to review the published literature to establish whether haemostatic agents and sealants are an effective option for lymphocele prevention following urological procedure.
Materials and methods: An extensive PubMed search was performed including the following keywords: “lymphocele”, “lymphocele prevention”, “fibrin glue”, “collagen patch”, “fibrin patch”, and “haemostatic material”. The search, which collected data until January 2000, was restricted to the full text available articles in the English language and human studies.
Results: Our research identified 64 articles, among these only four fulfilled the inclusion criteria. A total of 133 patients underwent surgery and were treated with haemostatic agents and/or sealants to reduce the lymphoceles formation. The mean age was 56.1 years. A negligible variability in study design and in results and complication reporting is common. The 6.45% of patients treated with haemostatic biomaterials developed lymphocele. The rate difference of lymphoceles formation and recurrence between patient groups treated with sealant than in the controls groups is small (6.45% vs 6.88%).
Conclusions: The evidences presented in the examined studies are only preliminary and insufficient to draw significant conclusions. A major, multicentre, randomized controlled trial is strongly needed.
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Mini-Laparoscopy: Instruments & Economics
Phillip P. Shadduck, MD FACS, Assistant Consulting Professor of Surgery, Duke University, Durham, NC,
Eduardo Moreno Paquentin, MD, FACS,
Associate Professor of Surgery,
Centro Medico ABC Santa Fe
Mexico City, Mexico,
Gustavo L. Carvalho, MD, PhD, MSc, MBA,
Associate Professor of Surgery,
University of Pernambuco,
Attending Surgeon,
Department of Surgery,
Hospital Universitário Oswaldo Cruz
Recife, Brazil, Jay A. Redan, MD, FACS,
Medical Director,
Minimally Invasive General Surgery
Florida Hospital Celebration Health,
Celebration, Florida,
Professor of Surgery,
University of Central Florida College of Medicine,
Orlando, Florida
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Mini-laparoscopy (Mini) was pioneered more than 20 years ago, initially with instruments borrowed from other specialties and subsequently with tools designed specifically for Mini. Early adoption of Mini was inhibited though by the limitations of these first-generation instruments, especially functionality and durability. Newer generation Mini instruments have recently become available with improved effector tips, a choice of shaft diameters and lengths, better shaft insulation and electrosurgery capability, improved shaft strength and rotation, more ergonomic handles, low-friction trocar options, and improved instrument durability. Improvements are also occurring in imaging and advanced energy for Mini. The current status of mini-laparoscopy instruments and economics are presented.
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