Natural Orifice Transluminal Endoscopic Surgery

Natural Orifice Transluminal Endoscopic Surgery, NOTES.
"scarless" abdominal surgery with an endoscope passed through a natural orifice (MOUTH, URETHRA, ANUS, VAGINA) then through an internal incision in the stomach, vagina, bladder or colon, thus avoiding any external incisions or scars.

1. “The limits of the possible can only be defined by going beyond them into the impossible.” NOTES Presenter : Dr. Kemba Padu Moderator : Prof. G. S. Moirangthem

2. Introduction Natural Orifice Transluminal Endoscopic Surgery An experimental surgical technique " scarless " abdominal surgery with an endoscope passed through a natural orifice (MOUTH, URETHRA, ANUS, VAGINA) then through an internal incision in the stomach, vagina, bladder or colon, thus avoiding any external incisions or scars

3. convergence of laparascopic surgery and therapeutic endoscopy.

4. These trends have set the stage for the development of even less invasive methods to treat conditions in both the gut lumen and in the peritoneal cavity In the first published description,Kalloo et al demonstrated the feasibility and safety of a per-oral transgastric endoscopic approach to the peritoneal cavity with long-term survival in a porcine model. This was soon followed by other transgastric peritoneal procedures in the porcine model, including tubal ligation,cholecystectomy , gastrojejunostomy , splenectomy,oophorectomy with tubectomy .

5. HISTORY Endoscopy can be used to do procedures beyond the wall of the GIT was known since 1980 when the first transluminal feeding gastrostomy was described by Gauderer et al. Kozarek et al. reported first of successful endoscopic drainage of pancreatic pseudocyst in 1985. The first report of oral peritoneoscopy done in animals was published by Kalloo et al. in 2004.

6. In September 2007, Novare announced the successful completion of the first NOTES gallbladder removal (TV) procedures. In March 2008, Dr Ricardo Zorron , of Brazil, performed the first series of NOTES cholecystectomy on four patients via transvaginal route

7. In India Transgastric appendectomy in humans By Dr. G V Rao and Dr. N Reddy. (Hyderabad, India) Famous bollywood actress ‘ Shilpa Shetty ’ and south Indian actress ‘ Khusboo ’ have recently undergone transgastric appendicectomy

8. Additional benefits of NOTES over laparoscopy Lack of skin incision, improving cosmesis Reduced post operative pain & wound complica . Possibility of anesthesia other than general Preferable approach for obese patients and for those with conditions that affect the abdominal wall such as scars, burns, infections Diminished risk of postoperative hernias Easier access for difficult to reach by open/ lap like esophagus & rectum Can be use even in ICU Decreasing physiologic & immune response to surgery Others- earlier recovery, reduced adhesion development, shorter postoperative ileus

9. NOSCAR To discuss this vision, 14 leaders from the AmericanSociety of Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) met in New York City on July 22 and 23, 2005. The members of the original working group coined the acronym NOSCAR as one that would be appropriate for incision less surgery. NOSCAR stands for the Natural Orifice Surgery Consortium for Assessment and Research

10. NOSCAR structure

11. NOSCAR The group identified the barriers that needed to be surmounted for the development of translumenal endoscopic intraperitoneal surgery and developed a list of next steps and guidelines to move this concept ahead. The group therefore agreed that the term Natural Orifice Translumenal Endoscopic Surgery (NOTES) best described the emerging field

12. Potential Barriers to Clinical Practice by NOSCAR Access to peritoneal cavity Gastric (intestinal) closure Prevention of infection Development of suturing and anastomatic devices Spatial orientation Development of a multitasking platform to accomplish procedures Management of intraperitoneal complications Physiologic untoward events Compression syndromes Training Other

13. ACCESS TO THE PERITONEAL CAVITY To reach lower abdomen: Stomach To reach heart/thorax: - Oesophagus To reach upper abdomen: Vagina Rectum Bladder

14. Overall, the logistics of transvisceral surgery are universal the natural orifice is accessed with the aid of a flexible multichannel scope incision is made through the visceral wall using a needle-knife a wire is passed into the peritoneal cavity using a modified Seldinger technique a dilating balloon is variably used to obtain a suitable access tract a catheter, guide tube, or overtube is placed over the guide-wire and insufflation is achieved with CO2 scope is advanced into the peritoneal Cavity viscerotomy is closed

15. Transvaginal access has the longest history of use for intraperitoneal procedures, prior to the recent description of NOTES. In 1949,Bueno described a series of transvaginal appendectomies performed with open instruments (without an endoscope) at the time of hysterectomy can be established using a posterior colpotomy created under direct vision with open instruments, or with the use of direct trocar insertion under laparoscopic guidance

16. Advantages not require the use of a flexible endoscope or transanal endoscopic microsurgery (TEM) platform vaginal access is quickly and easily obtained under direct vision. Because a dilating ( nonbladed ) trocar is used to stretch the incision, the incision quickly collapses to a smaller diameter after removal of the trocar . The gallbladder or specimen is removed easily from the trocar , either with or without an endobag . Using a vaginal speculum, the incision is easily visualized, and a single stitch can be placed to close the incision without difficulty “hybrid” NOTES approach, with at least one laparoscopic port used for initial visualization, retraction, and assistance with the dissection Lesser infection rate Use of rigid instruments

17. Disadvantages rectal and colonic injuries, small bowel injuries, ureterovaginal fistula formation, vulvar lacerations, and bladder injuries assistance from a gynecologist experienced in transvaginal access should be considered, at least initially, in the performance of transvaginal NOTES The risk of infertility after transvaginal NOTES procedures is unknown Use only in 50% of population(female) Not use in previous pelvic or vaginal surgery Disparuenia

18. Transgastric access second-most frequently reported access route At least 70 transgastric peritoneoscopy procedures reported by Nau et al[15,16] and Nikfarjam et al[17], several series which have reported at least cholecystectomies , appendectomies, PEG rescue, and transgastric stapled cystogastrostomy All access were obtained in the anterior stomach ( antrum or body) using needle knife cautery and balloon dilation through a flexible endoscope except in peg and cystogastrostomy

19. Can be performed with placement of a laparoscopic port prior to gastrotomy creation to allow laparoscopic guidance and insufflation Some with hybrid method with laproscope Dilation of the gastrotomy appears to be preferable to cutting a long gastrotomy because, the dilated gastrotomy shrinks down in size as the uncut muscle contracts.

20. Disavantages cautery burns to the anterior peritoneum or the under surface of the liver injuries to surrounding organs or the gastroepiploic vessels Control of both the pnuemoperitoneum and gas volumes inside the stomach are essential to the success of transgastric NOTES poorly suited to advanced procedures which require complex, flexible instrumentation small native diameter of the esophagus makes extraction of large, bulky specimens potentially hazardous.

21. Transesophageal access Per-Oral Esophageal Myotomy (POEM) for achalasia Currently transesophageal access has been used to perform only procedures on the esophageal wall transesophageal mediastinal or thoracic access through a submucosal tunnel may be clinically feasible in the future

22. Transrectal access Has been the least reported in the literature Can be done on TEM plateform En-face visualization for upper abdominal exploration and interventions as retroflextion of endoscope is not needed The luminal diameter is more complaint, able to accept larger instruments and allow for specimen retrieval

23. Transvesical Port is placed at the most anterior positioning in sagittal plan Reduced risk of visceral injuries unique lower abdominal access that is inherently sterile, and available in both genders in contrast to the transvaginal access The combination transgastric–transvesical access aims to overcome many limitations like exposure, organ retraction, grasping and limited triangulation. Difficulty is not encountered with maintaining a seal around the scope in the transvesical approach; thus, obtaining and maintaining pneumoperitoneum through a transvesical portal appears feasible

24. At this point in time an isolated port raises limitations in performing NOTES complex procedures. It is predictable that for moderately complex procedures, multiple ports may be needed. In this regard the transvaginal-transabdominal (hybrid) approach is the most appealing, whereas for pure NOTES, transgastric coupled with transvesical access may be a preferred method.

25. the specific indications that are best suited for each orifice will need to be defined Transrectal & transvaginal access approaches prove to be the most forgiving in terms of ease of access, ability to reach the upper abdomen, complications, and the ability to introduce both flexible and rigid instruments through the orifice it is possible that these approaches may become “workhorse” approaches for intraperitoneal NOTES procedures or specimen removal in female and male patients, respectively

26. VISCERAL CLOSURE Transvaginal closure is currently the most feasible closure method for NOTES, as the incision is closed by direct suturing. Aside from potential injuries to surrounding structures, there have been no reports of vaginal dehiscence or herniation through the vaginal incision. vaginal wound dehiscence would likely not be as potentially dangerous as a gastric leak or a rectal leak, which would introduce highly caustic or infectious luminal contents into the abdomen

27. transgastric closure currently requires the use of flexible endoscopic clips or tissue anchors, T-fasteners with or without laparoscopic sutures to buttress the closure Innovative solutions for transgastric closure that have been reported in humans include the creation of a gastric valve mechanism made with tissue anchors, through which a gastrotomy is created Using an aggressive grasping and needle-delivery device, full-thickness bites create an imbricated ridge of tissue that acts as a valve, allowing visualization while maintaining pneumogastrium when the endoscope is withdrawn from the peritoneum into the lumen. At closure, full-thickness serosa -to- serosa approximation is easily achieved due to excellent visualization.

28. Flexible endoscopic suturing devices

29. Completely endoscopic means for closing gastrostomies will need to be developed and evaluated in human studies for transgastric NOTES to become feasible without laparoscopic assistance Transesophageal NOTES closure has so far been reported using endoscopic clips to close the longitudinal mucosal incision at the entrance to the submucosal tunnel during POEM These clips slough off into the GI tract, with healing of the mucosal incision demonstrated on follow-up endoscopy

30. Closure of transrectal NOTES access has so far been accomplished by incorporating the rectotomy into a handsewn coloanal anastomosis This increases the safety of transrectal NOTES since it uses accepted anastomotic techniques, but limited to resections of the left colon and rectum The safety of transrectal closures left in situ (not incorporated into the anastomosis ) remains to be determined TEM literature suggest intraperitoneal rectal closures can be performed as safely as those without peritoneal entry during full-thickness rectal tumor excision

31. RISK OF INFECTION The notion of introducing surgical instruments through non-sterile orifices into the normally sterile peritoneal cavity runs counter to years of established surgical dogma NOTES have adopted the routine use of preoperative intravenous antibiotics combined with local application of antibiotic or antiseptic solutions such as povidone -iodine at the site of visceral entry as a precaution.

32. Risk of infection continue… transvaginal approach concerns about increased infectious risk with a transvaginal approach compared to conventional laparoscopy have not been substantiated Urinary tract infection, abscess in the pouch of Douglas, wound infection, vaginal mycosis, bacterial vaginitis , with a combined incidence of 1%, which is comparable to the rate of infectious complications seen with conventional laparoscopic

33. Risk of infection continue… transgastric some cross contamination occurs during transgastric peritoneoscopy , but degree of contamination is not dependent on the pre-existing level of bacteria in the stomach despite the documented levels of contamination, no clinically obvious infections were found with a minimum of 30 d of follow-up Patients with PPIs have significantly higher levels of bacteria in the stomach compared to those not on PPIs the optimal perioperative management of patients on PPIs undergoing NOTES requires further study

34. Risk of infection continue… transesophageal and transrectal access have a theoretically higher risk of infectious complications due to their proximity to the oropharyngeal and colonic flora, respectively The fear of increased infectious risk from NOTES procedures has so far not been substantiated by examining available clinical outcomes and bacteriologic studies. It is likely that Ⅳ antibiotics alone for transgastric procedures, along with some form of luminal disinfection for transvaginal , transrectal or transesophageal procedures will be the ultimate strategy adopted clinically

35. DEVELOPMENT OF ENDOSCOPIC SUTURING OR ANASTOMOTIC DEVICES The development of these devices was deemed to be necessary by the white paper in order for NOTES to ultimately be applied to the wide spectrum of current surgical therapy Currently, two types of endoscopic suturing devices have been approved Over-Stitch™ (Apollo Endosurgery , Inc., Austin, TX, USA) the Tissue Apposition System (TAS, Ethicon Endosurgery,Cincinnati , OH, USA) And newer g- Prox Tissue Grasper from USGI Medical

36. TAS has two T-fasteners attached together with a sliding lock on the connecting suture. This system is flexible and easy to apply but has been associated with risk of injury to adjacent structures because the extramural deployment is blind

37. T-tag applier + knotting element The TAS system works by sequentially deploying a threaded T-tag through the bowel wall on each side of a defect using an endoscopic hollow bore needle; once two threaded T-tags have been placed on either side of a defect, the two threads are cinched together and trimmed by a one-way locking mechanism in order to approximate both sides of the luminal defect

38. The OverStitch ™, in contrast to T-tag based systems, employs a lateral needle passing mechanism more similar to conventional suturing techniques But requires assistance from an endoscopic grasper, and may be limited by the visual and mechanical constraints of conventional flexible endoscopes Human use data will be needed to adequately evaluate the potential of the OverStitch ™ for use in luminal closures

39. The Eagle Claw suturing device with a semi-circular needle.

40. g- Prox Tissue Grasper allows the surgeon to grasp a full-thickness bite of tissue and then perforate it perpendicularly with a 19-gauge needle. The needle is preloaded with a suture with two expandable baskets. The first basket is expelled on one side of the grasped tissue, which is then released, allowing the grasper to either be reversed for a figure-of-eight suture or used again the same way for a simple stitch. The second bite is pierced again with the needle and the second basket is deployed. A one-way cinching device approximates the two baskets, creating a tight, imbricated closure of the enterotomy edges This device has achieved closure of gastrostomies as securely as hand sutures

41. Closure of a NOTES gastrotomy using the g- prox system

42. The development of endoscopic anastomotic devices has proceeded even more slowly The only reports of NOTES procedures with anastomoses have utilized handsewn coloanal anastomoses during colorectal resections, or a flexible, powered surgical stapler Development of flexible, articulating, low-profile staplers is needed to make creation of anastomoses or luminal closures during NOTES more feasible. Additional features which may make application of stapling technology to NOTES more feasible include the addition of visualization and steering capabilities.

43. SPATIAL ORIENTATION Inherent difficulties to flexible endoscopes, have the potential to create a difficult operation, also increase the risk of complications current NOTES techniques may alter the usual surgical anatomy that is seen due to the difficulty in achieving adequate retraction without laparoscopic instruments the spatial confusion created by retroflexion when using a flexible endoscope

44. Solution use of rigid endoscopes whenever possible through transvaginal or transrectal approaches, or through umbilicus in the case of transgastric surgery Future solutions- may use of small, wireless cameras that are able to provide a wider, overhead view of the surgical field, and can be moved to the appropriate location as needed. Use of this type of camera has been described for human single-incision laparoscopy (SIL) cases

45. DEVELOPMENT OF A MULTITASKING PLATFORM Issues with current flexible scopes include the lack of a multitasking platform, the number and size of access channels, the inability to position and then fix or “stiffen” the endoscope to allow robust retraction and exposure, the inability to control insufflations pressures, fixed visual horizons that force the surgeon to adjust to tilted or inverted views Inadequate suction/irrigation capabilities.

46. Examples of the novel application of multi-lumen operating platforms for NOTES TEM platform TransPort and Cobra platform - multi-channel access port for transgastric NOTES Olympus R scope The Anubis® platform from Karl- Storz EndoSamurai Direct-Drive Endoscopic System

47. The Transanal Endoscopic Operations device from Karl- Storz allows the insertion of rigid or flexible instruments through the anus and is currently used for performing TEM excisions of rectal tumors . It also has the potential to serve as a stable transrectal natural orifice translumenal endoscopic surgery (NOTES®) platform

48. The TransPort ™ multi-channel access device used as a transgastric natural orifice translumenal endoscopic surgery platform. It has a steering mechanism similar to a flexible endoscope, along with multiple, large-diameter channels to accommodate a small-diameter flexible endoscope and other large caliber flexible endoscopic instruments (g- Prox ® tissue anchor device is shown).

49. The Cobra triangulating scope

50. The Olympus R

51. EndoSamurai is a prototype, advanced platform in development by Olympus. To operate the system, a surgeon uses an intuitive, bi-manual interface to control instruments with multiple degrees of freedom (inset shows close-up of endoscope tip with working instruments

52. Direct-Drive Endoscopic System from Boston Scientific is a prototype,advanced multi-channel platform currently in development, featuring instruments with multiple degrees of freedom controlled through a bi-manual user interface. Inset figure shows close-up of device tip with a small diameterflexible endoscope in place

53. COMPLICATIONS OF NOTES Bleeding Physiologic complications & Compression syndromes intraoperative abdominal hypertension subcutaneous emphysema transvaginal injuries- bladder, rectal,small bowel. intra-abdominal abscess UTI transient brachial plexus injury dislodgement of an intrauterine device vaginal granulation tissue. transgastric esophageal hematomas,laceration,perforation

54. TRAINING NOSCAR has taken an initial step to expand participation of investigators interested in or already working on NOTES from around the globe and have outlined criteria for who can participate the white paper recommends NOTES procedures be performed by multi-disciplinary teams after a period of laboratory training in a properly equipped facility in order to maximize patient safety and ensure continuing regulatory acceptance of early NOTES development

55. Training cont.. Future NOTES practitioners will likely need some form of fundamental surgical training, along with platform- specific and procedure-specific training once the field has undergone significant development The current paradigm of performing NOTES primarily with flexible endoscopes is reaching the limits of practicality and safety, and will arguably become quickly obsolete with the availability of advanced multitasking platforms

56. CONCLUSION transvaginal access has been the most feasible access route for NOTES procedures Luminal closure appears to be most feasible with a transvaginal approach, with smaller but nevertheless good outcomes also reported for transgastric and transesophageal closures the feasibility of true, intraperitoneal transrectal closures remain limited by the fact that the only closures performed to date have been hand-sewn coloanal anastomoses

57. Infection appears to be a non-issue with regard to transvaginal and transgastric surgery with the use of preoperative Ⅳ antibiotics and local disinfection in the case of transvaginal procedures additional data required to more accurately estimate the infection risk with transesophageal and transrectal procedures Development of suturing and anastomotic devices for NOTES has progressed slowly, with limited clinical data on their use so far

58. the development of true multitasking platforms for NOTES has been slow and has not yet reached the clinical arena The optimal management of intraoperative complications has still not been determined, but the data suggest that intraoperative hemorrhage may not automatically require conversion to laparoscopy The incidence of compression syndromes appears low, as long as procedures are performed primarily with controlled, laparoscopic insufflation using CO2

59. Additional major complications specific to NOTES procedures that would normally not occur during the corresponding laparoscopic operations have been noted in the literature. These types of complications absolutely need to be reported in order to constructively analyze the current status of NOTES and optimize patient selection and techniques to minimize their occurrence

60. recommendations for NOTES training, there are no data to provide more specific recommendations outside of previous recommendations in the white paper and those from large NOTES registries Finally, it may be useful to re-prioritize the development of NOTES to focus on high-yield colorectal and esophageal applications that are more likely to succeed in the near term, instead of seeking the holy-grail of being able to perform entire, complicated procedures through transgastric access alone.

61. Does NOTES have a future? NOTES, by addressing “Sources of Invasion”, represents the next logical progression of surgical development, a key step along the MIS continuum Sources of Invasion Abdominal wall incisions Post-op recovery/RTNA General anesthesia Financial burden Site of care Infrastructure requirements Clinician skill level Open NOTES Laparoscopic/ Sustaining Improvements “Hybrids” Endoscopically -Assisted Laparoscopy Laparoscopically -Assisted Endoscopy Intra- lumenal Non-Invasive Appendectomy Cholecystectomy Diagnostic Peritoneoscopy Ventral Hernia ? ? ? ?

62. . Thank you