Broad Clinical Utilization of NOTES. Is It Safe ?

Santiago Horgan, MD, Ozanan R Meireles, MD, Garth Jacobsen, MD, Bryan Sandler, MD, Kari Thompson, MD, Toshio Katagiri, MD, Sonia Ramamoorthy, MD, Michael Sedrak, MD, Thomas Savides, MD, Alberto Ferreres, MD, Saniea Majid, MD, Sheetal Nijhawan, MD, . University of California San Diego, San Diego – CA

Background: NOTES has been the focus of several studies as a less invasive alternative to conventional laparoscopy to access and treat intra-cavitary organs. For the last 5 years, much has been accomplished with animal studies, yet the clinical utilization of this novel technique is still very modest. After two years of experience in the lab, we started our clinical experience. This paper reports our experience with clinical utilization of NOTES procedures from 2007 to 2010.

Methods: Under UCSD IRB approved trials, 87 patients were enrolled under seven different NOTES protocol from 2007 to 2010, were a NOTES procedure was offered as an alternative to conventional treatments. The treated pathologies were cholelithiasis, biliary dyskinesia, acute and chronic appendicitis, ventral hernias, morbid obesity and achalasia. The access routes included Trans-gastric (TG), Trans-vaginal (TV) and Trans-esophageal (TE).

Results: Among the 87 patients enrolled on our NOTES program, 10 were male and 69 female. Eight-six patients underwent a surgical procedure starting with diagnostic laparoscopy, and 80 patients were deemed to proceed with a NOTES approach. There were 6 aborted NOTES procedures at the time of the initial peritoneoscopy before creating a NOTES access route. The reasons to not proceed with a NOTES procedure on the TV Cholecystectomy group it was due to large amount of pelvic adhesions in 3 patients and a severely inflamed gallbladder in one patient; on the TG appendectomy group it was due to the presence of localized peritonitis in one patient; and on the TEEM group it is was due to the presence of megaesophagus with inability to clean the esophagus from food debris. The NOTES procedures performed were 48 TV cholecystectomies, 4 TV appendectomies, 8 TG cholecystectomies, 2 perirectal peritoneoscopy, 2 TG appendectomies, 3 TV ventral hernia repair, 5 Trans-esophageal endoscopic myotomy (TEEM), 4 TV sleeve gastrectomy and 4 TG sleeve gastrectomies (the average BMI for the sleeve gastrectomy groups was 39.9 kg/m²). There were no intra-operative complication and no conversion to standard laparoscopy during those procedures. The average hospital stay was 1 to 2 days. One patient required an Emergency Department visit due to nausea and vomiting (TV cholecystectomy). To date, 3 patients who underwent TV cholecystetomy have become pregnant.

This experience demonstrates that NOTES is safe, feasible and reproducible with previous training in the lab,a consistent team, and high volume. Certainly, prospective randomized studies using large patient population are necessary to assess the long-term results of NOTES procedures.

Session: SS14
Program Number: S084

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