Natural orifice translumenal endoscopic surgery (NOTES)

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Overview

Historical Perspective

Experimental Evolution

Advantages Over Current Surgical Techniques

What has been achieved so far?

Challenges and Drawbacks

Human Experience

Potential Applications

Future Directions

Current Technological Developments

Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR)

Conclusions

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Editor-In-Chief: Mohammed A. Sbeih, M.D. [1]

Related Key Words and Synonyms: Natural orifice translumenal endoscopic surgery, single incision laparoscopic surgery, minimally invasive surgery, transanal endoscopic microsurgery, Natural orifice surgery consortium for assessment and research.

Overview

Natural orifice translumenal endoscopic surgery (NOTES) is an experimental surgical technique whereby "scarless" abdominal and thoracic operations can be performed. A diagnostic or therapeutic procedures can be performed by getting access to the peritoneal cavity or the thoracic cavity through a hollow viscous. NOTES involves passing surgical instruments and a tiny camera through a natural orifice (mouth, urethra, anus, etc.), then the procedure can be performed through an internal incision in the hollow viscous (stomach, vagina, colon, etc.) thus avoiding scars and external incisions through the skin, muscles, and nerves. The patients recover more quickly and experience less pain (visceral pain only instead of visceral and somatic pain) and better cosmesis. The postoperative complications such as wound infections and hernias are significantly reduced.

Animal models and cadavers have been used to demonstrate that NOTES procedures are safe and feasible. Some of the NOTES applications are abdominal cavity screening and organs biopsy, appendectomy, cholecystectomy, tubal ligation, gastrojejunostomy, partial hysterectomy, oophorectomy, colorectal resection and trans-esophageal myotomy.

NOTES describes going beyond the margins of a lumen (hollow organ). The word translumenal could be spelled as "transluminal". Analogies are found with nomen, foramen or abdomen which build the corresponding adjective form with an "i" (nominal, foraminal, abdominal) instead of "e".

Historical Perspective

  • In 1901, Dimitri Ott from Russia performed transvaginal inspection of the peritoneal cavity. In the same year, the first experimental laparoscopy was reported by Georg Kelling (a German Surgeon) who initially used a cystoscope to insufflate and explore the abdominal cavity of a dog [1].
  • In 1940s, the first natural orifice procedure has been mentioned. Culdoscopies were performed using an endoscope passed through the recto-uterine pouch to view pelvic organs [2].
  • Laparoscopic surgery innovation was introduced in the late 1980s. Minimally invasive surgery started spreading worldwide in 1987, when the first laparoscopic cholecystectomy was reported by Dr. Philippe Mouret Spaner (a French gynecologist) [3][4].
  • Before the concept of NOTES; the term flexible transluminal endoscopy had been used by a multicenter team of investigators (the Apollo Group) in 1990 [5].
  • In 2002, Gettman et al published a transvaginal nephrectomy in a porcine model [6].
  • The first NOTES procedure (a transgastric endoscopic appendectomy) in human being has been performed in India in 2003 by Dr. G.V. Rao and Dr. N. Reddy [7]. This procedure has not been published or reported at that time.
  • NOTES was originally described in animal models by researchers at Johns Hopkins Medical Center in Baltimore in the United States. Dr. Anthony Kalloo published the first report of a true transluminal procedure in 2004. The procedure was a transgastric peritoneoscopy in a porcine model [8][9].
  • Senior leadership from the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) organized a working group of surgeons and gastroenterologists in 2005 to develop standards for NOTES practice. This group is known as the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) [10][11].
  • The first NOTES international conference was held in Scottsdale, Arizona (in the United States) March 9-11, 2006. One hundred forty physicians from 11 countries met to develop a detailed roadmap for overcoming the technical barriers of NOTES that had been identified in the original White Paper of NOSCAR.
  • EURO-NOTES Foundation has been established in 2006 in cooperation between European Asociation for Endoscopic Surgery (EAES) and the European Society of Gastrointestinal Endoscopy (ESGE) to focus on all activities regarding Natural Orifice Transluminal Endoscopic Surgery (NOTES). The first meeting was held in Berlin, Germany June 23, 2006.
  • Japan launched the JWNOTES (Japan Working group for NOTES) in 2007.
  • International Prospective Multicenter Trial on Clinical NOTES (IMTN Registry) has been designed as a multiinstitutional prospective documentation registry started in Brazilian centers in July 2007. It aimed to accept international data, and provide information regarding NOTES results and complications worldwide [12].
  • Radical sigmoidectomy using a pure NOTES transanal approach was first described in 3 human cadavers in 2007 by Whiteford et al. They used TEM as an endoscopic platform without the need for any abdominal incisions [13].
  • In early March 2007, the NOTES Research Group in Rio de Janeiro (in Brazil), led by Dr. Ricardo Zorron, performed the first series of transvaginal NOTES cholecystectomy in four patients, based in previous experimental studies. The first human transvaginal endoscopic cholecystectomy case was reported in 2007 [14][15].
  • In 2007, the first transvaginal laparoscopically assisted cholecystectomy in the United States was formally operated by Marc Bessler [16]. The same operation has been performed for the first time in France by Marescaux et al in 2007 [14]. In the same year, the first transgastric cholecystectomy in the United States was performed by Lee Swanstrom [17].
  • The first published human NOTES procedure was by Marks et al in 2007 [18]. The procedure was a transgastric rescue of a prematurely dislodge gastrostomy tube.
  • In late March, 2008, Dr. Santiago Horgan became the first US surgeon to perform transgastric appendectomy and remove a patient's appendix through the mouth. He also applied the EndoSurgical Operating System (EOS) on pigs to perform the entire operation through the stomach without laparoscopic assistance or any abdominal incision [19].
  • In late 2008, surgeons from Johns Hopkins Medical Center removed a healthy kidney from a woman donor using NOTES. The surgery was called transvaginal donor kidney extraction [20].
  • The first NOTES transanal rectosigmoid resection for rectal cancer using TEM and laparoscopic assistance was performed on a patient at the Hospital Clinic in Barcelona by a team of surgeons from the Hospital Clinic in Barcelona and Massachusetts General Hospital/Boston in November 2009 (Dr. Antonio Lacy and Dr. Patricia Sylla) [21].

Experimental Evolution

The fields of gastrointestinal surgery and interventional endoscopy are converging since the advent of the interventional endoscopic therapy field. Gastroenterologists and therapeutic endoscopists have started performing more invasive interventions than before. Recently, they have started to manage cases that was managed only surgically. In the other hand, surgical interventions in the abdominal, peritoneal, and thoracic cavities have become less invasive than before and a new minimally invasive surgical methods have been invented to minimize trauma. The evolving concept of natural orifice translumenal endoscopic surgery (NOTES) combines the techniques of minimally invasive surgery with flexible endoscopy. This permits performing certain procedures endoscopically by passing the endoscope and the surgical instruments through a natural orifice, then transluminally into areas that would not otherwise be accessible endoscopically. A successful transgastric gastrojejunostomy procedure in a porcine survival model (a long-term survival) was an important step in proving that NOTES maybe feasible; it demonstrated that basic techniques in surgery such as organ removal and anastomoses could be performed via natural orifices [22].

In the late 1990s, a multicenter team of investigators (the Apollo Group) developed the concept of flexible transluminal endoscopy (a term used before NOTES) [5]. The first published report of a true transluminal procedure in 2004 by Kalloo et al [9] demonstrated the possibilities of penetrating the gastric wall and operating in animal model using a perorally introduced flexible endoscope [23]. NOTES procedures moved quickly from a concept to clinical trials on humans based on many preclinical studies. These studies demonstrated that several types of NOTES operations can be performed in animal survival models and human cadavers [24][25][26][27][28]. Puncturing one of the viscera to perform NOTES procedures leaded to many questions regarding the infectious complications and the reliable incisional closure. Many clinical trials have been tried to answer these questions before proceeding to clinical NOTES [29].

NOTES procedures have been expanded in the last few years to cover a wide range of complex surgical operations by using the right translumenal route, endoscopic platform and the suitable instrumentation. Initially and over the last few years, endoscopic access to the peritoneal cavity using transoral (transgastric) route has been intensely investigated to perform various abdominal procedures, these procedures include cholecystectomy [30], appendectomy, splenectomy [31], ligation of fallopian tubes [32], gastrojejunostomy [33], peritoneal exploration and organ resection [34], lymphadenectomy [35], partial hysterectomy [36], oophorectomy [37], interventions on pelvic organs and other abdominal procedures. Recently, alternate access routes for NOTES procedures have been investigated such as transvaginal, transesophageal, transcolonic/transanal and transvesical/transurethral routs. The most rapidly evolved experimental studies were transvaginal NOTES procedures, including cholecystectomy [38][39], nephrectomy and appendectomy [40], and the first human case was described in 2007 [14][15]. Cholecystectomy, which is a high volume and relatively simple end organ operation, has been the focus of most early NOTES research studies. Recently, NOTES approach has been extended from the peritoneum to other body compartments such as the thoracic cavity (mediastinum, heart and lung) through a transesophageal approach [41][42]. Other recent animal studies have been focused on transgastric intrauterine procedures.

NOTES has also inspired the development of new and novel instrumentation and innovative surgical techniques for minimally invasive and endoscopic procedures. Gergard Buess (from Germany) introduced in the 1980s the Transanal Endoscopic Microsurgery (TEM), a natural orifice procedure used for full-thickness resection of rectal tumours followed by suture closure of the resultant defect [43]. TEM fulfils most requirements for the ideal NOTES operating platform based on what was published in NOSCAR white paper. TEM provides stable base, suction, irrigation, multiple working ports, pneumoperitoneum maintainance, and the capacity to close the viscotomy [44][45].

Recently, Robotic surgery has been investigated to be applied in NOTES procedures, a miniature in vivo robot has been developed for NOTES. The robot can be advanced through the esophagus into the peritoneal cavity. The robot may provide a stable platform for visualization and manipulation. This has been tested in a porcine model as well.

Investigators are trying to eliminate the laparoscopic component of NOTES procedures in order to perform them through the natural orifices only without any laparoscopic assistance or guidance.

Advantages Over Current Surgical Techniques

Proponents and researchers have recognized the potential ability of the NOTES field to revolutionize minimally invasive surgery by eliminating the body incisions. NOTES could be the next major paradigm shift in surgery, just as laparoscopy was the major paradigm shift during the 1980s and 1990s. Potential advantages of NOTES include [46]:

  • There are faster recovery, shorter hospital stay (usually the patient is discharged on postoperative days 1 or 2 if the procedure is not complicated), and less physiologic insult in NOTES than laparoscopy or laparotomy procedures. There are some ongoing laboratory studies which are trying to reveal and compare the cytokine levels between NOTES procedures and laparoscopy or laparotomy procedures. One study on animals has reported that the circulating levels of cytokines (IL1, IL6, and TNF-alpha) are similar in NOTES and other approaches immediately after the surgery. However, in the later postoperative period, the levels of the cytokines was lower in NOTES procedures compared with the open or laparoscopic approaches [47].
  • NOTES can avoid and minimize the potential complications of wound infections. Wound infection is a common surgical complication, with a reprted incidence varies between 2% to 25%, depending on the type of surgery [48][49]. Eliminating all skin incisions would eliminate the adverse impact of wound infection on the health care costs and patients' recovery [50].
  • NOTES Decreases the incidence of incisional hernias and postoperative adhesions. The rates of small intestinal obstruction after a laparoscopic surgery are lower than the rates after an open surgery and will perhaps be further less with NOTES procedure [51].
  • Moving the equipment to the patient (portable NOTES instruments) may avoid transporting the patient to the operating room, and thus making some NOTES procedures suited for an intensive care unit.
  • Anesthesia requirements in NOTES are relatively less than other types of surgery. Some NOTES procedures could be performed under conscious sedation.
  • Theoretically, NOTES causes less immunosuppression for the patient than other surgical approaches.
  • Postoperative pulmonary and diaphragmatic function are better in NOTES procedures.
  • Better cosmetic results with the potential for scarless abdominal surgery even when peritoneal intervention is required [52].
  • NOTES may have an advantages in specific subpopulations. It can be performed in morbidly obese patients, in whom traditional access to the peritoneal cavity can be difficult because of abdominal wall thickness, thus an easy alternative in these patients.
  • Theoretically, patients may prefer NOTES procedure over laparoscopic procedure based upon the assumption that it is scarless and less painful. Studies and surveys demonstrated that patients prefer NOTES if it is safe and effective [53].
  • In NOTES procedures, there is no need for single large incision through which the resected organ could be extracted. This is one of the advantages of NOTES over single-incision laparoscopic surgery (SILS).

What has been achieved so far?

  • Laboratory Reports
  • Human Cases

Current Challenges and Drawbacks to Clinical Application of NOTES

  • Puncturing one of the viscera to perform the surgical procedure. This needs to be assessed thoroughly regarding the presence of long term complications, higher infection rates, and the reliability of puncture closure. Methods of reliable full thickness, watertight closure for the puncture sites in different organs should be developed. There are three closure methods:
  • Endoscopic Clips can be used to close the wound (from the periphery to the center). It is considered tight and safe but more clinical studies should be conducted to confirm the safety of this closure technique.
  • Laparoscopic closure using the single-hand fashion by inserting a needle-holder and the scope through tiny trocars.
  • New technological closure devices are underway to be used.
  • Instrumentation is still inadequate to perform all NOTES procedures. Innovative instruments are needed to perform various NOTES procedures more easily.
  • Loss of triangulation of optics and instrumentation may limit the range of motion for performing the procedure and may obscure part of the operation field. The current version of NOTES instruments and endoscopes may preclude such triangulation in NOTES procedures [54].
  • A high quality of training should be provided for those who are going to perform NOTES procedures (surgeons or gastroenterologists). They should know abdominal anatomy and surgical principles, and be able to use flexible endoscopes professionally. They also should masterfully exhibit the ability to manage complications.
  • An argument can be made that single-incision laparoscopic surgery (SILS) can be more convenient than NOTES for some procedures, especially with the presence of advanced surgical technologies that could be applied in laparoscopic surgery [55][56].
  • Surveys showed that most women may not favor transvaginal NOTES procedures over laparoscopic approach, especially young nulliparous women who are concerned about the sexual function [57]. However, another study showed that there is considerable public interest in NOTES and women would be receptive to this new surgical technique because of decreased risk of hernia and operative pain [58]. Cultural and geographical variations may also play a roll in the decision to accept a transvaginal surgery or not.
  • There are some technical constraints and challenges which may limit the surgeon ability to perform certain procedures. For example, it may be very challenging for the surgeon to maintain spatial orientation during the NOTES procedure, and the procedure performance can be limited to certain points of natural entry. To provide a straight access to the operating field; lower abdominal and pelvic NOTES procedures usually performed via a transgastric approach. Upper abdominal procedures and cholecystectomy usually performed via transvaginal or transanal approach. Many investigators have encountered these constraints along with some ethical challenges [59].
  • It is more difficult to handle complications in NOTES compared with other approaches because of the limited space available for the NOTES instruments. This may require conversion of the procedure to be open or laparoscopic sometimes. Beside the complications of any surgical operation (laceration, perforation and bleeding, etc.), NOTES complications may also include injury to abdominal organs, bowel perforation or injury, biliary fistulae, biliary leaks, urinary incontinence, fecal incontinence and peritonitis. Recent studies reported that 5 to 10 percent of NOTES procedures could be complicated, most of the complications occur in the transgastric approach [59].
  • In NOTES procedures, There is higher risk of over insufflation of the peritoneal cavity by using a flexible endoscope. This may decrease the venous return to the heart and lead to undesired systemic effects, such as hemodynamic instability and respiratory compromise [60]. This could be prevented in laparoscopic surgery by using pressure sensors. There should be continuous monitoring of intra-abdominal pressures during NOTES procedures; this has been applied in animal studies [59][60]. Using a standard autoregulated insufflators, which is used in laparoscopic surgery, and feedback pressure valves in flexible endoscopes can also be a solution for this problem [61][62][63].
  • Financial resources are required for the technological developments and NOTES implementation [64].
  • Costly and time consuming NOTES training sessions should be provided for surgeons and gastroenterologists before they could be able to apply NOTES clinically [64].
  • In general, operative time may be longer in some NOTES procedures than the standard laparoscopic approach. Adequate instrumentation and training might shorten the time required for NOTES in the future.

Human Experience

There are hundreds of human cases have been reported since the first human NOTES case in India in 2003 [65]. Drs. G.V. Rao and D.N. Reddy performed transgastric appendectomy at the Asian Institute of Gastroenterology in Hyderbad, India in 2003. This was a heady experience in the NOTES field.

More than 500 cases have been reported in Germany and more than 300 cases have been reported in Brazil [66][59]. Many human cases have been reported in the United States and in other countries. Most of the reported cases are not purely NOTES but with laparoscopic assistance. A few number of the reported cases are pure NOTES procedures.

Another heady human experience was performing a NOTES procedure outside the operating room (in the bedside) by Marks et al . The procedure was a transgastric retrieval of a dislodged gastrostomy tube [67].

Potential Applications

NOTES procedures have been performed through different natural orifices. So far, transvaginal approach is the most commonly used and has the highest success rate for certain procedures.

Transvaginal NOTES

This is the most common apprach to be used in NOTES procedures. This approach has been used for cholecystectomy, appendectomy, colon resections, abdominal wall hernia repair, and sleeve gastrectomy [59]. Transvaginal cholecystectomy and transvaginal appendectomy have been performed in humans. Around 85% of the Notes procedures that have been reported in Germany is transvaginal cholecystectomy (the most common) [66]. There are many advantages for this approach which include:

  • The organ (Gallbladder, appendix or others) can be extracted easily outside the body through the flexible walls of the vagina even the large organs.
  • It is relatively easier and safer to perform the procedure through this approach. Vaginal wall closure is less complex than gastric wall closure and has less complications rate.
  • Transvaginal NOTES approach has lower complications rates than other accesses.

The drawback of this approach is that it can be used only in females. Also, the NOTES surgeon should have the basics of gynecological surgery before perform a transvaginal procedure. Women may present with dyspareunia and infertility after the procedure, also there is a potential risk for urinary tract infection after cannulation of the urinary bladder (required in transvaginal NOTES procedures). There is a risk for injury to nearby organs, the rectum and the sigmoid colon are at higher risk than other structures, that is why visualizing the pelvis directly by a laparoscope (through the trocar site) may be a safe method to ensure there are no injuries for pelvic organs.

Transvaginal cholecystectomy are usually performed with a single 5mm umbilical port. An additional 3mm transabdominal port can be used as a safety precaution in few cases [68]. The average operating time to perform the procedure is 2 hours. Blood loss is less than 50 ml in most cases [68]. Using the laparoscopic hook which is inserted via the umbilical port to dissect the gallbladder from the liver is considered easier, quicker and safer than the dissection by using the smaller size endoscopic hook [68]. Currently, laparoscopic clipping of the cystic duct is the safest and most secured method for securing the duct [68]. More occlusive endoscopic clips and instrumentation should be developed.

In transvaginal NOTES (and most NOTES procedures), insufflation through a laparoscopic port (which can be used also for single laparoscopic instrument insertion) is better controlled than endoscopic insufflation [69].

Transanal/Transrectal NOTES

Transanal rectosegmoid resection using transanal endoscopic microsurgery (TEM) and laparoscopic assistance has been demonstrated to be feasible and safe in a swine survival model and in human cadavers [70]. Currently, there are clinical trials that aim to assess the oncological safety of this approach in treating benign and malignant colorectal tumors.

Transanal colorectal resection procedures requires a stable platform for endolumenal and direct translumenal access to the peritoneal cavity. The first clinical case of a NOTES transanal resection for rectal cancer using TEM and laparoscopic assistance has been performed successfully by a team of surgeons from Barcelona and Boston in 2009 [21]. The progression and substantial improvement in NOTES instrumentation may optimize this approach to be widespread applied in humans, and may ultimately permit completely NOTES transanal colorectal resection instead of abdominoperineal resection (APR), low anterior resection (LAR) and laparoscopic colorectal resection procedures.

Transgastric NOTES

Initially, there were difficulties in achieving orientation and navigation based on retroflection of the endoscopes to visualize the upper abdomen and perform upper abdominal procedures. Better results had been achieved for lower abdominal surgeries, such as pelvic surgery, tubal ligation, and appendectomy.

This NOTES approach is more sophisticated than the transvaginal one, especially in terms of gastric wall closure after extracting the organ (requires laparoscopic assistance [71]. Also, the complications rate is higher in this rout compared with transvaginal route. Trials in the field (on animal and cadaver models) are trying to create a new devices and techniques to simplify the stomach incision closure.

Appendectomy, cholecystectomy and cancer staging have been performed via this approach [72]. Retrieval of dislodged endoscopic gastrostomy tube via this approach has been reported as well [67]. however, all cases require Some degree of hybridization is required for all transgastric NOTES procedures. This approach can be used in all patients (males and females) but the extracted specimen (through the oral cavity) needs to be relatively smaller than those extracted by other routs.

In general, the following steps should be considered for most NOTES transgastric procedures:

  • The patient should be in an overnight fasting state. General anesthesia is inducted and single dose intravenous antibiotics are administered (amoxicillin and metronidazole). The position of the patient is usually Lloyd-Davies position.
  • Gastric lavage should be done before the procedure using chlorhexidine solution.
  • The puncture site is chosen for adequate visibility to perform the procedure. The best areas of entry are the proximal body and the distal antrum (both are relatively avascular) [73].
  • A flexible endoscope is inserted via the oral cavity to the stomach, the puncture is made by a needle knife. The puncture site is dilated by an endoscopic balloon and and the scope is inserted into the peritoneal cavity.
  • Intraperitoneal pressure is controlled using laparoscopic carbon dioxide insufflator and the procedure is performed. Usually 2 to 3mm trocars are used in the procedure.
  • The puncture site is closed by a suturing device after extracting the specimen or the organ via the oral cavity.

Peritonitis and esophageal rupture may occur after transgastric procedures. In general, complications are more common in transgastric procedures than in transvaginal procedures.

Transesophageal NOTES

This approach can be used for the management of achalasia (failure of relaxation of the lower esophageal sphincter that cause dysphagia). Many cases of per oral endoscopic myotomy (POEM) have been performed successfully to treat achalasia [74]. Esophageal injuries could be prevented during performing the procedure by using gastroesophageal overtubes. The instruments and ports for transesophageal NOTES have more restrictions in their size and shape compared with other approaches. Large organ (specimen) extraction is not suitable for this approach (a maximal diameter of 2 cm) according to the relatively smaller size of esophageal lumen compared with other hollow organs.

Transurethral/Transcystic NOTES

Future Directions

Operating on intensive care unit patients may be the future progression in NOTES procedures and may offer many benefits. Transgastric placement of diaphragm pacing for weaning the ICU patients from the ventilator may lead to several potential benefits over other methods of pacing [75]. This procedure could be performed at the bedside.

NOTES may become the preferred method to operate on selected patients (specific population). Morbidly obese patients and those with severe intra abdominal adhesions are good candidates for NOTES.

More studies should be conducted to find clear clarifications for the following issues [76]:

  • The best and the safest way to traverse the wall of the lumen in order to get access to the organ.
  • Controlling the complications of every single NOTES procedure.
  • Improving spatial orientation to perform the procedure.
  • The best closure for the translumenal incisional site. Methods of reliable full thickness, watertight closure for the puncture sites in different organs should be developed.
  • Specific ways for organ extraction through the natural orifices.
  • Methods to prevent infections during NOTES procedures.
  • Anesthesia level requirement for every NOTES procedure.
  • Optimal instrumentation and devices for every NOTES procedure.

Current Technological Developments

The development of NOTES instruments is emerging to make these procedures feasible and safe. These instruments include platforms and many other tools, such as suturing devices and anastomotic (nonsuturing) devices [77]. The preferred way to gain access to the peritoneal cavity via a hollow viscus (lumen) is a very small incision (minimal) followed by a balloon expansion and dilatation. A tiny incision can be made using a sphincterotome or a needle knife.

Although a direct insertion of an endoscope and the NOTES instruments is possible, Overtube is usually used to permit multiple entries to the field the procedure and to perform complex maneuvers.

Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR)

Senior leadership from the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal Endoscopic Suregons (SAGES) organized a working group of surgeons and gastroenterologists who met in New York City on July 22 and 23, 2005 to develop standards for the practice of this emerging technique. This group is known as the Natural Orifice Surgery Consortion for Assessment and Research (NOSCAR). A White Paper on NOTES was released by NOSCAR simultaneously in two medical journals in May 2006 [78]. This paper identified the major areas of research needed to be addressed before NOTES can become a viable clinical application for patients. These areas included development of a reliable closure technique for the internal incision, prevention of infection, and creation of advanced endoscopic surgical tools [79].

NOSCAR tasks include the following:

  • Producing White Papers which focus on the challenges that need thought and research.
  • Tracking the groups of similar research projects that address the previous challenges.
  • Organizing the research projects, enhance collaboration and attract funding to key areas of study.
  • Building a robust outcomes database by collecting submission of data.
  • Fostering collaborative clinical trials.

The White Paper on NOTES and the guidlines for participation in NOSCAR can be found in the external links below [80].

Conclusions

Natural orifice transluminal surgery (NOTES) is a rapidly evolving field which may shift the minimally invasive surgery world from laparoscopic and video assisted thoracic surgery to procedures that can be done via the natural body orifices without any abdominal or thoracic incisions. NOTES may be a feasible, safe, and reasonable option for abdominal surgery. It may provide many advantages and lessen many surgical complications. New NOTES procedures should be experimental at the beginning, and they should be performed only in research labs in advanced institutions before applying NOTES clinically.

We are on the way for routine clinical applications of NOTES by the steady progression of the field. Patient safety and the research trials that ensure this safety is paramount. Innovative instruments are needed for the surgeons and gastroenterologists to perform safe NOTES procedures. The development of such therapeutic techniques and advanced endoscopic devices will allow the endoscopists to perform various procedures more easily, such as resection of large and deep mucosal lesions and taking full thickness biopsies [81].

International NOTES research groups, such as NOSCAR, EURO-NOTES, ASIA-NOTES, NOSLA (Natural Orifice Surgery Latin America), EATS (European Association of Translumenal Surgery) and others currently work to improve NOTES field and aim to provide registries for NOTES procedures worldwide.

Finally, enthusiasm and conducting laboratory studies and clinical trials are required for further improvements in the field in order to provide the best possible patient care for our patients.

Published Trials

  • A transgastric debridement of necrotizing pancreatitis was performed using flexible endoscope in 2000 by Seifert et al [82]. This was initial description for the transgastric access to perform procedures.
  • In 2002, Gettman et al published a transvaginal nephrectomy in a porcine model [83].
  • A novel endoscopic peroral transgastric approach to the peritoneal cavity was tested in a porcine model in acute and long-term survival experiments at Johns Hopkins Medical Center in 2004 by Kalloo et al [9]. He demonstrated the feasibility and safety of this approach to be an alternative to laparoscopy and laparotomy. The peritoneal cavity was examined, and a liver biopsy specimen was obtained. The gastric wall incision was closed with clips [9].
  • A transgastric lymphadenectomy has been performed in a survival porcine model by Fritscher-Ravens et al and reported in 2004 [84]. This study showed that EUS (Endoscopic Ultrasonography) guided transgastric approach for lymph node selection and lymphadenectomy is feasible.
  • A transgastric fallopian tube ligation has been reported in a porcine survival model in 2005 by Jagannath et al [85].
  • A transgastric partial hysterectomy and oophorectomy in a porcine survival model has been reported in 2005 by Wagh et al [86].
  • A transgastric cholecystectomy and cholecystogastric anastomosis in a nonsurvival model has been reported in 2005 by Park et al [87].
  • A transgastric gastrojejunostomy procedure in a porcine survival model has been reported in 2005 by Kantsevoy et al [22].
  • A transvesical liver biopsy has been performed on pigs (survival and nonsurvival models) and reported in 2006 by Lima et al [88]. This study provided encouragement for additional preclinical studies of transvesical surgery to design new intra-abdominal scarless procedures in what seems to be third generation surgery.
  • A transgastric splenectomy has been performed in a nonsurvival porcine model and reported in 2006 by Kantsevoy et al [26].
  • A new transgastric closure method for stomach incisions has been compared to other closure methods in 2007 by Ryou et al [89]. The study showed by using ex vivo porcine stomach model that prototype gastrotomy device yields the highest median air leak pressure (most leak-resistant gastrotomy closure) compared to the QuickClip closure method and the hand-sewn closure. This method also dramatically diminishes the time for incision and gastrotomy closure to approximately 5 min [89].
  • A transcolonic abdominal exploration in a swine survival model has been performed by Fong et al and reported in 2007 [90]. In contrast to the transgastric method, a transcolonic approach provides more consistent identification of structures in the upper abdomen and provides better en face orientation and scope stability.
  • A transgastric diaphragmatic pacing and peritoneal exploration procedure in a nonsurvival porcine model has been performed by Onders et al and reported in 2007 [75]. This study demonstrated the feasibility of transgastric mapping of the diaphragm and implantation of a percutaneous electrode for therapeutic diaphragmatic stimulation.
  • A transgastric intraperitoneal pressure measurement procedure has been performed in a nonsurvival porcine model and reported in 2007 by Meirless et al [69]. This study demonstrated that the use of an on-demand unregulated endoscopic insufflator for translumenal surgery can cause large variation in intraperitoneal pressures, which may lead to hemodynamic compromise. Well-controlled intraabdominal pressures that is achieved with a standard autoregulated laparoscopic insufflator maybe much safer.
  • Radical sigmoidectomy using a pure NOTES transanal approach was first described in 3 human cadavers in 2007 by Whiteford et al [13]. They used TEM as an endoscopic platform to perform the procedure without the need of any abdominal incisions [13]. This showed that NOTES sigmoid colon resection with en bloc lymphadenectomy and primary anastomosis can be performed successfully, and it is possible to complete the critical steps of NOTES sigmoid resection, en bloc lymphadenectomy, primary anastomosis, and retrieval of an intact specimen without any incisions by using transanal endoscopic microsurgery instrumentation.
  • Completely NOTES transvaginal cholecystectomy has been reported by a team of surgeons in Philadelphia (USA). The patient was discharged on the day of surgery and has not suffered any complication after 1 month of follow-up. Pure NOTES transvaginal cholecystectomy without aid of laparoscopic or needleoscopic instruments is feasible and safe in humans [38].
  • The first series of transvaginal NOTES cholecystectomy has been performed by the NOTES Research Group in Rio de Janeiro (Brazil) in 2007, based in previous experimental studies. The first human transvaginal endoscopic cholecystectomy case was reported in 2007 [14].
  • A transvaginal laparoscopically assisted endoscopic cholecystectomy has been reported by Marc Bessler [15].
  • Transgastric appendectomy has been performed by Santiago Horgan in 2008 [68]. The patient's appendix was removed through the mouth. Dr. Horgan also applied the EndoSurgical Operating System (EOS) on pigs to perform the entire operation through the stomach without laparoscopic assistance or any abdominal incision.
  • In late 2008, surgeons from Johns Hopkins School of Medicine removed a healthy kidney from a woman donor using NOTES. The surgery was called transvaginal donor kidney extraction.
  • The first case of robotic-assisted laparoscopic live-donor transvaginal nephrectomy with the uterus in place has been performed by a multidisciplinary team of surgeons at University of Pavia (Italy) in 2010 [91]. The initial experience with the combination of robotic surgery and transvaginal extraction of the donated organ has opened a new opportunity to minimize trauma in transplant surgery.
  • A NOTES transanal resection for rectal cancer using TEM and laparoscopic assistance has been performed in a 76-year-old woman at the Hospital Clinic in Barcelona by a team of surgeons from the Hospital Clinic in Barcelona and Massachusetts General Hospital/Boston in November 2009 [21].
  • Transvaginal purely endoscopic appendectomies were reported in 2008 by investigators from Germany and by another group of investigators from India [92][93].

Videos

External Links

References

  1. ↑ Litynski GS (1999) Endoscopic surgery: the history, the pioneers. World J Surg 23: 745-753
  2. ↑ Halim I, Tavakkolizadeh A. NOTES: The next surgical revolution? Int J Surg 2008; 6: 273-276
  3. ↑ Mouret P (1991) From the first laparoscopic cholecystectomy to the frontiers of laparoscopic surgery: the future perspectives. Dig Surg 8: 1124-1125
  4. ↑ SJ, Warnock GL. A brief history of endoscopy, laparoscopy, and laparoscopic surgery. J Laparoendosc Adv Surg Tech A 1997; 7: 369-373
  5. ↑ 5.0 5.1 Pasricha PJ (2007). "NOTES: a gastroenterologist's perspective". Gastrointest. Endosc. Clin. N. Am. 17 (3): 611–6, viii–ix. doi:10.1016/j.giec.2007.05.002. PMID 17640587. Retrieved 2012-02-16. Unknown parameter |month= ignored (help)
  6. ↑ Gettman MT, Lotan Y, Napper CA, Cadeddu JA (2002). "Transvaginal laparoscopic nephrectomy: development and feasibility in the porcine model". Urology. 59 (3): 446–50. PMID 11880100. Retrieved 2012-03-02. Unknown parameter |month= ignored (help)
  7. ↑ Rao GV, Reddy DN. Transgastric appendectomy in humans. Montreal: World Congress of Gastroenterology, 2006
  8. ↑ Kalloo AN, Singh VK, Jagannath SB, Niiyama H, Hill SL, Vaughn CA, Magee CA, Kantsevoy SV. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc 2004; 60: 114-117
  9. ↑ 9.0 9.1 9.2 9.3 Kalloo AN, Singh VK, Jagannath SB, Niiyama H, Hill SL, Vaughn CA, Magee CA, Kantsevoy SV (2004). "Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity". Gastrointest. Endosc. 60 (1): 114–7. PMID 15229442. Retrieved 2012-02-16. Unknown parameter |month= ignored (help)
  10. ↑ Rattner D, Kalloo A (2006). "ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. October 2005". Surg Endosc. 20 (2): 329–33. doi:10.1007/s00464-005-3006-0. PMID 16402290. Retrieved 2012-02-22. Unknown parameter |month= ignored (help)
  11. ↑ Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR)
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  19. ↑ Surg Endosc. 2009 July; 23(7): 1512–1518.Published online 2009 April 3. PubMed Central. doi: 10.1007/s00464-009-0428-0
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  71. ↑ Nikfarjam M, McGee MF, Trunzo JA, Onders RP, Pearl JP, Poulose BK, Chak A, Ponsky JL, Marks JM (2010). "Transgastric natural-orifice transluminal endoscopic surgery peritoneoscopy in humans: a pilot study in efficacy and gastrotomy site selection by using a hybrid technique". Gastrointest. Endosc. 72 (2): 279–83. doi:10.1016/j.gie.2010.03.1070. PMID 20541750. Retrieved 2012-02-27. Unknown parameter |month= ignored (help)
  72. ↑ Zorrón R, Soldan M, Filgueiras M, Maggioni LC, Pombo L, Oliveira AL (2008). "NOTES: transvaginal for cancer diagnostic staging: preliminary clinical application". Surg Innov. 15 (3): 161–5. doi:10.1177/1553350608320553. PMID 18614547. Retrieved 2012-02-27. Unknown parameter |month= ignored (help)
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  74. ↑ Pasricha PJ, Hawari R, Ahmed I, Chen J, Cotton PB, Hawes RH, Kalloo AN, Kantsevoy SV, Gostout CJ (2007). "Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia". Endoscopy. 39 (9): 761–4. doi:10.1055/s-2007-966764. PMID 17703382. Retrieved 2012-02-27. Unknown parameter |month= ignored (help)
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  77. ↑ Mummadi RR, Pasricha PJ (2008). "The eagle or the snake: platforms for NOTES and radical endoscopic therapy". Gastrointest. Endosc. Clin. N. Am. 18 (2): 279–89, viii. doi:10.1016/j.giec.2008.01.005. PMID 18381169. Retrieved 2012-02-23. Unknown parameter |month= ignored (help)
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  79. ↑ Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR)
  80. ↑ D. Rattner, A. Kalloo, and the SAGES/ASGE Working Group on Natural Orifice Translumenal Endoscopic Surgery
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  83. ↑ Gettman MT, Lotan Y, Napper CA, Cadeddu JA. Transvaginal laparoscopic nephrectomy: development and feasibility in the porcine model. Urology 2002; 59: 446-450
  84. ↑ Fritscher-Ravens A, Mosse CA, Ikeda K, Swain P (2006). "Endoscopic transgastric lymphadenectomy by using EUS for selection and guidance". Gastrointest. Endosc. 63 (2): 302–6. doi:10.1016/j.gie.2005.10.026. PMID 16427939. Retrieved 2012-03-01. Unknown parameter |month= ignored (help)
  85. ↑ Jagannath SB, Kantsevoy SV, Vaughn CA, Chung SS, Cotton PB, Gostout CJ, Hawes RH, Pasricha PJ, Scorpio DG, Magee CA, Pipitone LJ, Kalloo AN (2005). "Peroral transgastric endoscopic ligation of fallopian tubes with long-term survival in a porcine model". Gastrointest. Endosc. 61 (3): 449–53. PMID 15758923. Retrieved 2012-02-29. Unknown parameter |month= ignored (help)
  86. ↑ Wagh MS, Merrifield BF, Thompson CC (2005). "Endoscopic transgastric abdominal exploration and organ resection: initial experience in a porcine model". Clin. Gastroenterol. Hepatol. 3 (9): 892–6. PMID 16234027. Retrieved 2012-02-29. Unknown parameter |month= ignored (help)
  87. ↑ Park PO, Bergström M, Ikeda K, Fritscher-Ravens A, Swain P (2005). "Experimental studies of transgastric gallbladder surgery: cholecystectomy and cholecystogastric anastomosis (videos)". Gastrointest. Endosc. 61 (4): 601–6. PMID 15812420. Retrieved 2012-02-29. Unknown parameter |month= ignored (help)
  88. ↑ Lima E, Rolanda C, Pêgo JM, Henriques-Coelho T, Silva D, Carvalho JL, Correia-Pinto J (2006). "Transvesical endoscopic peritoneoscopy: a novel 5 mm port for intra-abdominal scarless surgery". J. Urol. 176 (2): 802–5. doi:10.1016/j.juro.2006.03.075. Retrieved 2012-03-01. Unknown parameter |month= ignored (help)
  89. ↑ 89.0 89.1 Ryou M, Pai RD, Pai R, Sauer JS, Sauer J, Rattner DW, Rattner D, Thompson CC, Thompson C (2007). "Evaluating an optimal gastric closure method for transgastric surgery". Surg Endosc. 21 (4): 677–80. doi:10.1007/s00464-006-9075-x. PMID 17160493. Retrieved 2012-03-01. Unknown parameter |month= ignored (help)
  90. ↑ Fong DG, Pai RD, Thompson CC (2007). "Transcolonic endoscopic abdominal exploration: a NOTES survival study in a porcine model". Gastrointest. Endosc. 65 (2): 312–8. doi:10.1016/j.gie.2006.08.005. PMID 17173916. Retrieved 2012-03-01. Unknown parameter |month= ignored (help)
  91. ↑ Pietrabissa A, Abelli M, Spinillo A, Alessiani M, Zonta S, Ticozzelli E, Peri A, Dal Canton A, Dionigi P (2010). "Robotic-assisted laparoscopic donor nephrectomy with transvaginal extraction of the kidney". Am. J. Transplant. 10 (12): 2708–11. doi:10.1111/j.1600-6143.2010.03305.x. PMID 21114647. Retrieved 2012-02-28. Unknown parameter |month= ignored (help)
  92. ↑ Bernhardt J, Gerber B, Schober HC, Kähler G, Ludwig K (2008). "NOTES--case report of a unidirectional flexible appendectomy". Int J Colorectal Dis. 23 (5): 547–50. doi:10.1007/s00384-007-0427-3. PMID 18256848. Retrieved 2012-02-29. Unknown parameter |month= ignored (help)
  93. ↑ Palanivelu C, Rajan PS, Rangarajan M, Parthasarathi R, Senthilnathan P, Prasad M (2008). "Transvaginal endoscopic appendectomy in humans: a unique approach to NOTES--world's first report". Surg Endosc. 22 (5): 1343–7. doi:10.1007/s00464-008-9811-5. PMID 18347865. Retrieved 2012-02-29. Unknown parameter |month= ignored (help)

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