BlueCross BlueShield of Tennessee Medical Policy Manual

Natural Orifice Transluminal Endoscopic Surgery

DESCRIPTION

Natural Orifice Transluminal Endoscopic Surgery (NOTES) is being investigated as a less invasive abdominal surgical technique.  In NOTES, a flexible endoscope is inserted through a natural orifice (e.g., mouth, anus and vagina).  A small internal incision in the stomach, vagina, bladder or colon then allows the endoscope access to the abdominal cavity.  Potential NOTES procedures include removal of the pancreas or appendix through an individual’s mouth.  Proposed benefits of this technique include avoidance of external scarring, less pain and lower risk of post-operative infection and immobility.

Another proposed NOTES approach is peroral endoscopic myotomy (POEM) as treatment of esophageal achalasia, a disorder characterized by prolonged occlusion of the lower esophageal sphincter (LES) and reduced peristaltic activity.  Using the oral cavity as the natural orifice entry point for myotomy of the LES, the procedure has the intent of reducing the overall invasiveness of surgery. 

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Well-designed studies in peer-reviewed journals that compare the natural orifice transluminal endoscopic surgery (NOTES) procedure to traditional surgery are not available.

The literature on the efficacy of peroral endoscopic myotomy (POEM) for treatment of esophageal achalasia primarily consists of case series, cohort studies and two non-randomized comparative studies.  No studies have determined efficacy and safety compared with a control group and no comparative effectiveness studies have evaluated long-term outcomes with POEM versus alternative treatment.  

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2014). Peroral endoscopic myotomy for treatment of esophageal achalasia (2.01.91). Retrieved July 16, 2015 from BlueWeb. (18 articles and/or guidelines reviewed)

Koti, R.S., Davidson, C.J., & Davidson, B.R. (2015). Surgical management of acute cholecystitis. Langenbecks Archives of surgery, 400 (4), 403-419. Abstract retrieved July 16, 2015 from PubMed database.

Patel, K., Abbassi_Ghadi, N., Markar, S., Kumar, S., Jethwa, P., & Zaninotto, G. (2015). Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Diseases of the Esophagus. Abstract retrieved July 16, 2015 from PubMed database.

Society of American Gastrointestinal and Endoscopic Surgeons. (2011). Guidelines for the surgical treatment of esophageal achalasia. Abstract retrieved July 16, 2015 from www.sagescms.org.

Talukdar, R., Inoue, H., & Reddy, D.N. (2014). Efficacy of peroral endoscopic myotomy (POEM) in the treatment of achalasia: a systematic review and meta-analysis. Surgical Endoscopy. Abstract retrieved July 16, 2015 from PubMed database.

U.S. Food and Drug Administration. (2007, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062875. Abstract retrieved October 26, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062875.pdf.

U.S. Food and Drug Administration. (2010, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082102. Retrieved October 7, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082102.pdf.

Yang, J., Wang, C., Li, J., Yang, W., Cao, G., Wong, H.M., Zhai, H., & Liu, W. (2015). Complete endoscopic thyroidectomy via oral vestibular approach versus areola approach for treatment of thyroid diseases. Journal Laparoendoscopic & Advanced Surgical Techniques, 25 (6), 470-476. Abstract retrieved July 16, 2015 from PubMed database.

Xu, Bin., Xu, Bo, Wen-Yan, Z.,Hai-Yan, G., Wang, L, Zhen-Sun, S, & Bin, H. (2015). Transvaginal cholecystectomy vs conventional laparoscopic cholecystectomy for gallbladder disease: a meta-analysis. World Journal of Gastroenterology, 21 (17), 5393-5406. (Level 1 evidence)

ORIGINAL EFFECTIVE DATE: 5/9/2009

MOST RECENT REVIEW DATE:  9/10/2015

ID_BT

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additional keyword(s): Transoral NOTES