Background: Natural orifice translumenal endoscopic surgery (NOTES) has been used to perform nephrectomy in the laboratory; however, clinical reports to date have used multiple abdominal trocars to assist the transvaginal procedure. Objective: To present our stepwise technique development and the first successful clinical case of NOTES transvaginal radical nephrectomy for tumor with umbilical assistance without extraumbilical skin incisions. Design, setting, and participants: The four transvaginal NOTES procedures were performed at two institutions after obtaining institutional review board approval. Various operative steps were developed experimentally in three clinical cases, and on March 7, 2009, we performed the first successful case of NOTES hybrid transvaginal radical nephrectomy without any extraumbilical skin incisions. Using one multichannel access port in the vagina and one in the umbilicus, laparoscopic visualization, intraoperative tissue dissection, and hilar control were performed transvaginally and transumbilically. The intact specimen was extracted transvaginally. Measurements: All perioperative data were accrued prospectively. A stepwise progression to the successful completion of the fourth case is systematically presented. Results and limitations: Intraoperatively, at incrementally more advanced stages of the procedure, the first three NOTES clinical cases were electively converted to standard laparoscopy because of rectal injury during vaginal entry, of failure to progress, and of gradual bleeding during upper-pole dissection after transvaginal hilar control, respectively. The fourth case was successfully completed via transvaginal and umbilical access without conversion to standard laparoscopy. Operative time was 3.7 h, estimated blood loss was 150 cm3, and hospital stay was 1 d. Final pathology confirmed a 220-g, pT1b, 7-cm, grade 2, clear-cell renal cell carcinoma with negative margins. The patient was readmitted for an intraabdominal collection that responded to drainage and antibiotics. Conclusions: We report our stepwise progression and the initial successful clinical case of NOTES hybrid transvaginal radical nephrectomy for tumor, assisted with only one umbilical trocar. Although transvaginal nephrectomy is feasible in the highly selected patient with favorable intraoperative circumstances, considerable refinements in technique and technology are necessary if this approach is to advance beyond mere anecdote.
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