title: Transvaginal hybrid NOTES cholecystectomy--results of a randomized clinical trial after 6 months.
abstract: BACKGROUND
  For cholecystectomy (CHE), both the needlescopic three-trocar technique with 2-3-mm instruments (needlescopic cholecystectomy (NC)) and the umbilically assisted transvaginal technique with rigid instruments (transvaginal cholecystectomy (TVC)) have been established for further reduction of the trauma remaining from laparoscopy.
  
  
  METHODS
  To compare the further outcome of both techniques for elective CHE in female patients, we analyzed the secondary end points of a prospective randomized single-center trial (needlescopic versus transvaginal cholecystectomy (NATCH) trial; ClinicalTrials.gov Identifier: NCT0168577), in particular, satisfaction with aesthetics, overall satisfaction, abdominal pain, and incidence of trocar hernias postoperatively at both 3 and 6 months. After 3 months, the domains "satisfaction" and "pain" of the German version of the Female Sexual Function Index (FSFI-d) were additionally evaluated to detect respective complications. A gynecological control examination was conducted in all TVC patients after 6 months.
  
  
  RESULTS
  Forty patients were equally randomized into the therapy and the control groups between February 2010 and June 2012. No significant differences were found for overall satisfaction with the surgical result, abdominal pain, sexual function, and the rate of trocar hernias. However, aesthetics were rated significantly better by TVC patients both after 3 and after 6 months (P = 0.004 and P < 0.001). There were no postoperative pathological gynecological findings.
  
  
  CONCLUSIONS
  Following TVC, there is a significantly better aesthetic result as compared to NC, even at 3 and 6 months after the procedure. No difference was found for sexual function.
authors: Department of Abdominal, Vascular and Transplant Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Ostmerheimer Strasse 200, 51109, Cologne, Germany, buliand@kliniken-koeln.de.
authors: Dirk Rolf
authors: DR
authors: Bulian
authors: Jurgen
authors: J
authors: Knuth
authors: Nicola
authors: N
authors: Cerasani
authors: Jonas
authors: J
authors: Lange
authors: Michael Alfred
authors: MA
authors: Ströhlein
authors: Axel
authors: A
authors: Sauerwald
authors: Markus Maria
authors: MM
authors: Heiss
mesh_terms: D017081:Cholecystectomy, Laparoscopic / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005705:Gallbladder Diseases / Q000601:surgery*; D006555:Hernia, Ventral / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D057605:Natural Orifice Endoscopic Surgery; D010149:Postoperative Pain / Q000453:epidemiology; D017060:Patient Satisfaction; D011446:Prospective Studies; D012725:Sexual Behavior; D013997:Time Factors; D016896:Treatment Outcome; D014472:Umbilicus / Q000601:surgery; D014621:Vagina / Q000601:surgery