Our group performed transvaginal hybrid cholecystectomies using a flexible endoscope in twenty women between 2009 and 2014. Only patients with symptomatic cholelithiasis or biliary dyskinesia were included; patients with acute cholecystitis, gallstone pancreatitis, or suspicion of malignancy were excluded. Women who previously underwent hysterectomy or pelvic surgery or open abdominal surgery were excluded. None of the patients suffered from a major complication. All patients successfully underwent the endoscopic procedure, and all were able to have their gallbladders removed transvaginally (in other words, none were “converted” to laparoscopy). There were no major complications, but there were three minor complications: One woman had an intrauterine device that had been in place at the time of the procedure, which was inadvertently dislodged. A second woman had a metal piece of the EndoGrab™ fracture and fall into the pelvis, which was not found at laparoscopy (even though it was seen on radiograph). It was left in place but never caused symptoms. A third patient had gallstones spill into the abdominal cavity upon retrieval, and we were able to remove these using an endoscopic Roth Net^® retrieval device (US Endoscopy, Mentor, OH).

All of the women had at least one laparoscopic trocar utilized, and three patients required a second trocar. Gallbladder retraction methods varied between simple suture retraction, EndoGrab™, and NovaTract™. Mean age of the group was 41 (range 20–66). The median operative time was 163 min (range 110–269). Transvaginal access was generally by direct dissection into the peritoneal cavity, although a 15-mm trocar was placed in five cases. While the trocar does aid in entering the peritoneum, its presence does create a “drag”-like effect, or friction, on the endoscope, which sometimes can be problematic during the procedure.

Thirteen of the patients listed above participated in a randomized clinical trial comparing NOTES transvaginal cholecystectomy with laparoscopic cholecystectomy, which was sponsored by NOSCAR [21]. In this trial, known as the “NOVEL” trial (Natural Orifice VErsus Laparoscopy), transvaginal cholecystectomy was found to be non-inferior to standard laparoscopic approaches in both pain and major complications. There was an unsurprising statistically significant difference in operative time, but no major biliary complications in the study. This study demonstrates both the safety and efficacy of the transvaginal approach.

Of note, during the period of time when the procedure was being offered, five women had consented to the procedure, three of whom were in the NOSCAR trial. One of the three women in the trial went on to develop acute cholecystitis and had to be taken out of the trial and operated on emergently. Two others decided against surgery altogether. One of them later went on to have a cholecystectomy two years later for acute cholecystitis, and the third patient did not return for follow-up. Two more recent patients who consented after the completion of the NOSCAR trial also changed their minds and opted against surgery.

There are several small published series of flexible endoscope transvaginal cholecystectomy in the literature, although the predilection does appear to be toward the use of rigid endoscopic and laparoscopic instrumentation. Palanivelu et al. [22] reported on their initial series of 10 transvaginal cholecystectomies, and although their mean operating time was similar to other studies (148 min), their complication rate was significant, with six of ten cases converted to laparoscopic cholecystectomy—two for hemorrhage—and one cystic duct leak controlled by ERCP and stenting. Forgione et al. [23] published their initial three cases using a flexible endoscope, although this group later adopted a rigid platform for further transvaginal cholecystectomies. Navarra et al. [24] published a series of six hybrid transvaginal cholecystectomies. Similar to our early technique, they reported gallbladder retraction with multiple transabdominal sutures. Salinas et al. [25] published a much larger series of 27 transgastric and 12 transvaginal cholecystectomies using a flexible endoscope and one laparoscopic port. Interestingly, their transvaginal mean operative time of 147 min was 10 min longer than the transgastric route, which has not been reported by other authors. They did, however, present a 25% minor complication rate. Horgan et al. [26] reported on four transvaginal cholecystectomies, among other NOTES procedures, in a series of cases utilizing the Incisionless Operating Platform (USGI Medical, San Clemente, CA). Their mean operating time was 86 min, and they utilized only one additional laparoscopic port. They reported no major complications. Santos et al. [27] reported on a series of seven transvaginal and seven conventional laparoscopic cholecystectomies. Their mean operative time was similar to our group at 162 min; they found less postoperative pain in the immediate postoperative period. Noguera et al. [28] published a randomized trial comparing transumbilical NOTES, transvaginal NOTES, and conventional laparoscopic cholecystectomy. Unsurprisingly, the transvaginal group took the longest in OR time, but it was faster than our series at 64.85 min. There were twenty patients in each group, and no major complications reported in the transvaginal group.