Early experience in human hybrid transgastric and transvaginal endoscopic cholecystectomy.

Salinas, Gustavo; Saavedra, Lil; Agurto, Hellen; Quispe, Rosa; Ramírez, Edwin; Grande, José; Tamayo, Juan; Sánchez, Victoria; Málaga, Daniel; Marks, Jeffrey M

BACKGROUND Abdominal procedures have been performed for a long time through the anterior abdominal wall. Since the first reports in the 1980s, laparoscopy has become the standard for cholecystectomy, with many advantages over open procedures. Now a natural-orifice approach to the peritoneal cavity may further reduce the invasiveness of surgery by either diminishing or avoiding abdominal incisions. Several orifice routes to the abdominal cavity have been described: transgastric, transvaginal, transvesical, and transcolonic. Although most experiences with the porcine model showed the possibility of these approaches, few surgeons reported experiences with humans. The authors present their complete early experience with transgastric (TG) and transvaginal (TV) cholecystectomies in human beings. METHODS Thirty-nine patients (4 males and 35 females) underwent hybrid NOTES procedures from January 2007 to January 2009. The mean age was 46 years (range = 19-83). The body mass index ranged from 20 to 41 and ASA was I-II. Transgastric (TG) cholecystectomy was performed in 27 patients and 12 patients had a transvaginal (TV) cholecystectomy. RESULTS The mean operative time was 140 min. Although operative times were slightly shorter in the TG group 005B137 +/- 34.6 min (range = 75-195)] compared to the TV route [147 +/- 31.5 min (range = 95-220)], there were no significant differences between the two groups (p = 0.5, Mann-Whitney U test). Patients were started on liquids within 1 h and discharged 2 h later, except the last 11 TG patients, who went home 24 h later because of enrollment in a separate protocol. An overall 20% morbidity rate and no mortality were found. The complication rates for the TG and TV groups were 18% (5/27) and 25% (3/12), respectively, which was not statistically significant (p = 0.6, chi(2) test). Seventy-five percent of complications (6/8) occurred the first year and 25% (2/8) during the second year of our experience. CONCLUSION Transgastric and transvaginal cholecystectomies are feasible. Although these NOTES procedures were laparoscopically assisted and current flexible endoscopes were used, it seems possible that major intra-abdominal surgeries may one day be performed without skin incisions. However, a learning curve is mandatory and, although there were no major bile duct injuries, there were NOTES-related complications. These trends toward incisionless surgery demand coordinated research in an interdisciplinary setting involving both surgeons and device manufacturers to further define appropriate indications, contraindications, and applications for natural-orifice surgery.