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Surgery Without The Scalpel

Mon, 06/16/2008 - 1:11pm
Incisionless Surgery: Surgery Without The Scalpel
There is a new type of surgical procedure emerging on the horizon that has been causing quite a buzz in the surgical community and which some feel could eclipse laparoscopy as lower-risk surgical alternative. This new procedure is Incisionless Surgery, which is also referred to as Natural Orifice Surgery (NOS) or Natural Orifice Translumenal Endoscopic Surgery (NOTES™). As the name implies, incisionless surgery requires no cuts to be made into the patient's abdomen, leaving the body's natural barrier to infection perfectly intact. Incisionless surgical procedures would use the body's natural orifices as the entry ports into the surgical site, accessing internal organs through the mouth, rectum, vagina or urethra. Examples of how this might work would include gastric bypass being performed by instruments and endoscopes inserted down the esophagus and into the stomach or fallopian tube ligation performed with instruments inserted into the vagina.

The potential benefits of incisionless surgery are fairly easy to see. The less invasive technique would significantly reduce recovery time as there would be no surgical wounds or associated trauma from which the patient would need to heal. The patient would also experience less physical pain and discomfort, reduced risk of infection and no visible scarring. In addition, certain incisionless surgical procedures would be less reliant on a completely sterile environment to ward off infection as is the case in many traditional procedures. This could make incisionless surgery an extremely valuable asset in battlefields and third world countries.

The EGS StomaphyX device is a sterile, single-use device for use in transoral tissue approximation and ligation in the GI Tract.
As good as it sounds, though, incisionless surgery is still in its infancy, if not its fetal stages. To date, a majority of the research, experimentation and testing regarding NOTES has been performed on animals. There have been a few of cases performed on human patients including transoral and transvaginal appendectomy and gall stone removals, but the numbers amount to only a handful. As such, there is currently no data available to prove that incisionless surgery is less risky than laparoscopy or that it delivers better patient outcome. Unfortunately, this leads to a bit of a Catch 22. One of the major hurdles facing NOTES testing in humans is the lack of dedicated technology and instrumentation that can accommodate this type of surgery. The latest generation of endoscopes and laparoscopic instrumentation excel in laparoscopy but are ill equipped to handle NOTES procedures. And, as there is not enough human testing to quantifiably prove the safety and best practices of NOTES, the development of new incisionless surgical technologies and instruments has been very slow.

Nonetheless, when looking back at the history of laparoscopy, it is very possible and even probable that NOTES will follow in its footsteps and eventually become a viable, mainstream option. It is based on this assumption that the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR)™ was formed. Seeing NOTES as a potential paradigm shift in patient care, NOSCAR was organized as a joint initiative supported by the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) to address the emerging technology and to produce a document that would serve as a guide for the responsible development of NOTES. NOSCAR ultimately produced a white paper and other criteria aimed at promoting and shepherding the development of incisionless surgery.

The work being done by NOSCAR is already benefiting NOTES by providing guidelines and a forum for research that will help move the procedure forward. In addition to this, a number of major medical device manufacturers, such as Covidien, Olympus, Ethicon Endo-Surgery and Karl Storz Endoscopy, that have teamed up with NOSCAR to encourage and promote research into varying aspects of incisionless surgery by supporting research grants.

EndoGastric Solutions' EsophyX System is indicated for the treatment of symptomatic, chronic GERD.
Covidien (Mansfield, MA) is global provider of healthcare products that is dedicated to improving surgical efficiency and patient outcome through minimally invasive approaches to surgery. The company recently announced that they have received FDA 501(k) clearance for their new Covidien SILS™ procedure kit, which is indicated for Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures. The devices in the kit allow surgeons to perform laparoscopic procedures through a single skin incision in the umbilicus, drastically minimizing pain and scarring. Covidien sees the development of these devices as an important step toward their ultimate goal of enabling incisionless surgery. Covidien is actively working with surgeons around the world to develop even less invasive approaches for surgery, such as NOTES. In 2007, the Company established the Covidien NOTES Research Fund in conjunction with NOSCAR to support clinical research in key technological areas of incisionless surgery, including peritoneal access, suturing and anastomotic devices.

Ethicon Endo-Surgery, Inc. (Cincinnati, OH) develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. They are also very committed to surgical innovation and, very early on, made a sizable pledge that funded NOSCAR's first research grants, whose 13 recipients are now engaged in the study of varying aspects of NOTES.

Olympus (Center Valley, PA) has long been leader in Gastrointestinal endoscopes, accessories and minimally invasive surgical products. They recently impressed the attendees of the Digestive Disease Week 2008 with a live demonstration of sedationless transnasal endoscopy using their innovative, super-slim 4.9-mm diameter GIF-N180 Slimsight video gastroscope to deliver superb image quality inside the upper GI tract. Sedationless transnasal endoscopy, a method for evaluating the digestive tract by inserting a slim endoscope through the patient's nose, allows for a complete upper endoscopy without the costs associated with anesthesia or conscious sedation. Olympus has also regularly supported development in NOTES technology with NOSCAR through the Olympus Medical Systems Research Fund.

USGI Medical's EndoSurgical Operating System (EOS) provides surgeons with the operating platform and tools required to perform surgery through the body's natural orifices.
In addition to the developments being made by these companies, there are a few smaller start-up companies that have already begun manufacturing and marketing surgical devices and systems specifically for NOTES. USGI Medical, Inc. (San Clemente, CA), a leader in incisionless surgery, offers the EndoSurgical Operating System™ (EOS), which provides surgeons with the operating platform and specialized tools required to perform surgery through a patient's mouth, other natural orifice or single incision, reducing or eliminating the need for external incisions into the abdomen. The system facilitates access and visualization of the operating field via the body's natural orifices and provides a stable operating platform to enhance surgical precision and control. It also allows the use of multiple, robust instruments similar to those in laparoscopy and enables rapid, durable suturing and wound closure. The EOS includes the TransPort™ Multi-lumen Operating Platform, the g-Prox® Tissue Grasper and Approximation Device, expandable tissue anchors and a variety of specialized instruments, all of which have received FDA 510(k) clearance for use in the United States.

The EOS is designed to address a wide range of surgical indications. Surgeons have used this system to complete the first transgastric gall bladder and appendix removals in the U.S. and to close the access incision (gastrotomy) in the stomach wall during NOTES procedures. In addition, many surgeons and gastroenterologists use the EOS routinely to perform an incisionless procedure to reduce the size of the gastric pouch and stoma in patients who experience weight regain after gastric bypass surgery. USGI also recently announced that they have licensed their incisionless surgery technology to Intuitive Surgical, makers of the da Vinci Surgical System, for use in medical robotics applications.

Another front-runner in emerging technology for incisionless surgery is EndoGastric Solutions (EGS), Inc. (Redmond, WA), a pioneer in endoluminal procedures for the treatment of upper gastrointestinal diseases, including gastroesophageal reflux disease (GERD) and other GI disorders. EGS's initial technologies involve modifying current open surgical and/or laparoscopic approaches by going through the mouth to access the stomach so that no incisions are needed. The company designs and manufactures single-use instruments that will enable incisionless solutions for gastroenterologists and surgeons.

Their StomaphyX™ device, which received FDA clearance in March 2007, is a sterile, single-use device for use in transoral tissue approximation and ligation in the GI tract. StomaphyX can be used to create durable large tissue folds in the gastrointestinal tract, decreasing the size of the stomach pouch and thus limiting the amount of food that patients can eat. Performed under endoscopic visualization, the StomaphyX is introduced into the body through the mouth. Once inside the stomach, the stomach wall is suctioned into the tissue port on the StomaphyX, creating a large plication. Non-resorbable fasteners are then deployed across the fold to hold the tissue in place. Typically 10 to 20 folds are required depending on patient anatomy. StomaphyX is the first transoral, fastener delivery system capable of delivering multiple fasteners with a single insertion, allowing the procedure to be easily and atraumatically customized to the patient's anatomy and individual needs.

EGS also offers the EsophyX™ System, which received FDA clearance in September 2007 and utilizes the company's innovative Serofuse™ Fastener. The EsophyX is indicated for use in endoluminal, transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia less than or equal to two centimeters in size in patients with symptomatic chronic gastroesophageal reflux disease.

The EsophyX™ Transoral Incisionless Fundoplication (TIF) procedure is a novel surgical procedure for the treatment of reflux disease. The TIF procedure emulates the principles of the laparoscopic fundoplication but without incisions and with an added benefit of versatility. The TIF procedure reconstructs a robust antireflux barrier, thus restoring the gastroesophageal junction back to what is believed to be its natural anatomical geometry.

In addition, EGS recently announced that it had signed an agreement with Karl Storz to partner in education and the marketing their systems with the Karl Storz line of quality GI video endoscopes. Karl Storz is also supporting NOTES research with NOSCAR through the Karl Storz Research Fund.

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