Prospective randomized trial of NOTES(r) cholecystectomy versus laparoscopic cholecystectomy

Michael L Kochman, MD1, Steven D Schwaitzberg, MD1, . NOSCAR(r) Clinical trial group2. 1SAGES, 2SAGES/ASGE/NOSCAR(r)

Background: The evolution of Natural Orifice Translumenal Endoscopic Surgery® (NOTES®) represents a case study in surgical procedural evolution. Beginning in 2004 with preclinical feasibility studies and followed by the creation of the NOSCAR collaboration of SAGES and ASGE, procedural development has followed a methodical pathway. The work of the Consortium has included a white paper analysis, funding for basic science and procedural development and, ultimately, the initiation of a prospective randomized clinical trial comparing NOTES cholecystectomy to laparoscopic cholecystectomy.

Results: 90 patients were randomized into the clinical trial. In the original trial design, there were both transgastric and transvaginal groups, however, enrollment into the transgastric group was ultimately not practicable and the arm was closed after 6 laparoscopic controls and 4 transgastric cases were randomized. 41 transvaginal and 39 laparoscopic controls were randomized into the main arms of the study. 37 transvaginal and 33 laparoscopic controls for transvaginal surgical procedures were performed. Operating time was longer in the NOTES group: 96.9 (64.97) minutes versus 52.1 (19.91) minutes. Intraoperative blood loss, length of stay and medication given in the PACU were equivalent in both groups. There were no conversions in the NOTES group to a conventional laparoscopic procedure, nor were there injuries, bile leaks, hemorrhagic complications, wound infections, and wound dehiscences in either group. There were no readmissions in either group. VAS pain scores were 3.4 (2.82) in the laparoscopic group and 2.9 (1.96) in the transvaginal group. Cosmesis scores were superior in the transvaginal group for most characteristics measured. SF-12 scores were equivalent at all postoperative time points.

Conclusions: 1. The study was powered for non-inferiority, which was demonstrated for the transvaginal group. 2. The safety profile for transvaginal surgery demonstrates that this approach is safe and produces at least equivalent clinical results with superior cosmesis and transient reduction in peri-procedure discomfort in the transvaginal group. 3. The study also demonstrates successful intersociety collaboration as a model for basic research, procedural development, investigation fundraising, and clinical trial execution for novel interventional concepts. 4. The transvaginal approach to cholecystectomy should not be considered experimental.

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