Natural orifice translumenal endoscopic surgery (NOTES) published trials

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Editor-In-Chief: Mohammed A. Sbeih, M.D. [1]Phone: 617-849-2629; Assistant Editor-In-Chief: Kristin Feeney, B.S. [2]

Synonyms and keywords: Natural orifice translumenal endoscopic surgery, Single incision laparoscopic surgery, Minimally invasive surgery, Transanal endoscopic microsurgery, Natural orifice surgery consortium for assessment and research, Society of american gastrointestinal and endoscopic surgeons.

Natural Orifice Translumenal Endoscopic Surgery (NOTES) Published Trials

  • A transgastric debridement of necrotizing pancreatitis was performed using flexible endoscope in 2000 by Seifert et al [1]. This was initial description for the transgastric access to perform procedures.
  • In 2002, Gettman et al published a transvaginal nephrectomy in a porcine model [2].
  • 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 [3]. 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 [3].
  • A transgastric lymphadenectomy has been performed in a survival porcine model by Fritscher-Ravens et al and reported in 2004 [4]. 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 [5].
  • A transgastric partial hysterectomy and oophorectomy in a porcine survival model has been reported in 2005 by Wagh et al [6].
  • A transgastric cholecystectomy and cholecystogastric anastomosis in a nonsurvival model has been reported in 2005 by Park et al [7].
  • A transgastric gastrojejunostomy procedure in a porcine survival model has been reported in 2005 by Kantsevoy et al [8].
  • A transvesical liver biopsy has been performed on pigs (survival and nonsurvival models) and reported in 2006 by Lima et al [9]. 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 [10].
  • A new transgastric closure method for stomach incisions has been compared to other closure methods in 2007 by Ryou et al [11]. 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 [11].
  • A transcolonic abdominal exploration in a swine survival model has been performed by Fong et al and reported in 2007 [12]. 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 [13]. 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 [14]. 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 [15]. They used TEM as an endoscopic platform to perform the procedure without the need of any abdominal incisions [15]. 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.
  • Pure 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 [16].
  • The first series of transvaginal 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 [17].
  • A transvaginal laparoscopically assisted endoscopic cholecystectomy has been reported by Marc Bessler [18].
  • Transgastric appendectomy has been performed by Santiago Horgan in 2008 [19]. 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 [20]. 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 [22][23].
  • Transesophageal endoscopic mediastinoscopy, lymph node resection, thoracoscopy, and pleural biopsy have been performed in a nonsurvival porcine model at Massachusetts General Hospital (Harvard University) by Willingham et al and reported in 2008 [24].
  • Peroral NOTES esophageal segmentectomy and anastomosis with single transthoracic trocar has been reported in 2011 by Rolanda et al [25].

References

  1. ↑ Seifert H, Wehrmann T, Schmitt T, Zeuzem S, Caspary WF (2000). "Retroperitoneal endoscopic debridement for infected peripancreatic necrosis". Lancet. 356 (9230): 653–5. doi:10.1016/S0140-6736(00)02611-8. PMID 10968442. Retrieved 2012-03-05. Unknown parameter |month= ignored (help)
  2. ↑ 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 2012-03-10. Unknown parameter |month= ignored (help)
  3. ↑ 3.0 3.1 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)
  4. ↑ 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)
  5. ↑ 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)
  6. ↑ 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)
  7. ↑ 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)
  8. ↑ Kantsevoy SV, Jagannath SB, Niiyama H, Chung SS, Cotton PB, Gostout CJ, Hawes RH, Pasricha PJ, Magee CA, Vaughn CA, Barlow D, Shimonaka H, Kalloo AN (2005). "Endoscopic gastrojejunostomy with survival in a porcine model". Gastrointest. Endosc. 62 (2): 287–92. PMID 16046997. Retrieved 2012-03-01. Unknown parameter |month= ignored (help)
  9. ↑ 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)
  10. ↑ Kantsevoy SV, Hu B, Jagannath SB, Vaughn CA, Beitler DM, Chung SS, Cotton PB, Gostout CJ, Hawes RH, Pasricha PJ, Magee CA, Pipitone LJ, Talamini MA, Kalloo AN (2006). "Transgastric endoscopic splenectomy: is it possible?". Surg Endosc. 20 (3): 522–5. doi:10.1007/s00464-005-0263-x. PMID 16432652. Retrieved 2012-03-01. Unknown parameter |month= ignored (help)
  11. ↑ 11.0 11.1 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)
  12. ↑ 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)
  13. ↑ Onders R, McGee MF, Marks J, Chak A, Schilz R, Rosen MJ, Ignagni A, Faulx A, Elmo MJ, Schomisch S, Ponsky J (2007). "Diaphragm pacing with natural orifice transluminal endoscopic surgery: potential for difficult-to-wean intensive care unit patients". Surg Endosc. 21 (3): 475–9. doi:10.1007/s00464-006-9125-4. PMID 17177078. Retrieved 2012-03-01. Unknown parameter |month= ignored (help)
  14. ↑ Meireles O, Kantsevoy SV, Kalloo AN, Jagannath SB, Giday SA, Magno P, Shih SP, Hanly EJ, Ko CW, Beitler DM, Marohn MR (2007). "Comparison of intraabdominal pressures using the gastroscope and laparoscope for transgastric surgery". Surg Endosc. 21 (6): 998–1001. doi:10.1007/s00464-006-9167-7. PMID 17404796. Retrieved 2012-03-01. Unknown parameter |month= ignored (help)
  15. ↑ 15.0 15.1 Whiteford MH, Denk PM, Swanström LL (2007). "Feasibility of radical sigmoid colectomy performed as natural orifice translumenal endoscopic surgery (NOTES) using transanal endoscopic microsurgery". Surg Endosc. 21 (10): 1870–4. doi:10.1007/s00464-007-9552-x. PMID 17705068. Retrieved 2012-02-15. Unknown parameter |month= ignored (help)
  16. ↑ Gumbs AA, Fowler D, Milone L, Evanko JC, Ude AO, Stevens P, Bessler M (2009). "Transvaginal natural orifice translumenal endoscopic surgery cholecystectomy: early evolution of the technique". Ann. Surg. 249 (6): 908–12. doi:10.1097/SLA.0b013e3181a802e2. PMID 19474690. Retrieved 2012-02-28. Unknown parameter |month= ignored (help)
  17. ↑ Marescaux J, Dallemagne B, Perretta S, Wattiez A, Mutter D, Coumaros D (2007). "Surgery without scars: report of transluminal cholecystectomy in a human being". Arch Surg. 142 (9): 823–6, discussion 826–7. doi:10.1001/archsurg.142.9.823. PMID 17875836. Retrieved 2012-02-15. Unknown parameter |month= ignored (help)
  18. ↑ Bessler M, Stevens PD, Milone L, Parikh M, Fowler D (2007). "Transvaginal laparoscopically assisted endoscopic cholecystectomy: a hybrid approach to natural orifice surgery". Gastrointest. Endosc. 66 (6): 1243–5. doi:10.1016/j.gie.2007.08.017. PMID 17892873. Retrieved 2012-02-28. Unknown parameter |month= ignored (help)
  19. ↑ Horgan S, Cullen JP, Talamini MA, Mintz Y, Ferreres A, Jacobsen GR, Sandler B, Bosia J, Savides T, Easter DW, Savu MK, Ramamoorthy SL, Whitcomb E, Agarwal S, Lukacz E, Dominguez G, Ferraina P (2009). "Natural orifice surgery: initial clinical experience". Surg Endosc. 23 (7): 1512–8. doi:10.1007/s00464-009-0428-0. PMC 2695868. PMID 19343435. Retrieved 2012-02-28. Unknown parameter |month= ignored (help)
  20. ↑ 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)
  21. ↑ Sylla P, Rattner DW, Delgado S, Lacy AM (2010). "NOTES transanal rectal cancer resection using transanal endoscopic microsurgery and laparoscopic assistance". Surg Endosc. 24 (5): 1205–10. doi:10.1007/s00464-010-0965-6. PMID 20186432. Retrieved 2012-02-15. Unknown parameter |month= ignored (help)
  22. ↑ 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)
  23. ↑ 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)
  24. ↑ Willingham FF, Gee DW, Lauwers GY, Brugge WR, Rattner DW (2008). "Natural orifice transesophageal mediastinoscopy and thoracoscopy". Surg Endosc. 22 (4): 1042–7. doi:10.1007/s00464-007-9668-z. PMID 18030521. Retrieved 2012-03-29. Unknown parameter |month= ignored (help)
  25. ↑ Rolanda C, Silva D, Branco C, Moreira I, Macedo G, Correia-Pinto J (2011). "Peroral esophageal segmentectomy and anastomosis with single transthoracic trocar: a step forward in thoracic NOTES". Endoscopy. 43 (1): 14–20. doi:10.1055/s-0030-1256012. PMID 21234836. Retrieved 2012-03-29. Unknown parameter |month= ignored (help)

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