The group in Hamburg, Germany, summarizes their results as follows [24]: All operations (n = 204) could be successfully performed in the described method except one case (0.5%). The latter case was converted to a traditional laparoscopic cholecystectomy due to severe acute inflammation. In 9 cases (4.5%), an additional abdominal port was used for larger clips, drainage, or a linear stapler.

The average operation time was 50 (23–110) minutes. In 9 cases (4.5%), the transvaginal approach was abandoned and no instruments were inserted through the vagina due to difficulties of the inspection of the pouch of Douglas. The most common reason for this decision was adhesions in the pelvis. These patients were not included in the group of the 204 patients.

There was one (0.5%) intraoperative and two postoperative (1.0%) complications. During the insertion of the transvaginal port, the urinary bladder was perforated with a 5-mm dissector in a patient with a previous hysterectomy. A transurethral catheter was placed for 3 days, and the injury healed spontaneously as was shown using contrast radiography. One patient (0.5%) developed a biliary fistula from the liver parenchyma and a laparoscopic closure with a suture on postoperative day 3 was performed. The other (0.5%) postoperative complication was an abscess in the pouch of Douglas 3 weeks after surgery, which was drained laparoscopically. No other complications occurred. The average length of the hospital stay was 2.1 days [1–7].

Zornig et al. asked their patients to be examined by the associated gynecologists within one week after hospital discharge, and 183 (90%) of the patients underwent this examination. Interestingly, the patient with the abscess in the pouch of Douglas was one of the patients who did not follow this recommendation. They were asked about discomfort or pain in the lower abdomen/pelvis or vagina, and the wounds in the vagina were inspected. A transvaginal ultrasound was performed. None of the examinations presented pathological findings. In another study, Zornig et al. compared the results of matched pairs, investigating transvaginal cholecystectomy with traditional laparoscopic cholecystectomy, and found no differences in all analyzed parameters with the exception of duration of the procedures and cosmesis [26]. The latter was based on subjective patient opinion after transvaginal procedures.

The EuroNOTES Clinical Registry (ECR) was created as a European database to monitor the clinical application of Natural Orifice Translumenal Endoscopic Surgery™ (NOTES^®) [27]. The ECR was sponsored by the EuroNOTES Foundation, founded in 2008 as a joint initiative of the European Society for Gastrointestinal Endoscopy (ESGE) and the European Association for Endoscopic Surgery (EAES). The concept of a NOTES clinical registry was announced at several congresses, and all members of ESGE and EAES performing (or intending to perform) NOTES procedures were asked to participate to the ECR.

Data were collected between May 2010 and April 2014, and are visible in an anonymous way online (http://​www.​euronotes.​world.​it). Although 62 accounts were created, indicating the number of centers that were interested in participating, only 14 centers participated in data collection. Procedures were included in the ECR retrospectively, so the ECR includes cases performed between April 2007 and April 2014.

At the time of publication in 2014, a total of 571 patients had been entered into the registry [27]. The most frequent procedure in the ECR was cholecystectomy, performed in 442 cases (78.5%). Cholecystectomy was performed in 4 different techniques:

Table 17.1 demonstrates patient characteristics, showing an average age of 45.3 years and a BMI of 25.3 kg/m. The mean operative time of transvaginal cholecystectomy was 60.5 min (15–270). Age and BMI did not differ significantly among the groups. In all cases, optics were introduced through the transmural access, i.e., transvaginal or transgastric technique.

The transvaginal approach was chosen in 430 of 442 cholecystectomies (97.2%), and only 12 patients underwent a transgastric hybrid approach. Analyzing the transvaginal approach, 145 cases were performed with the support of a flexible endoscope, 279 cases with the aid of a rigid laparoscope, and the remaining 6 cases were conducted with modified TEM equipment. In 406 cases, the transvaginal access was created with a direct surgical opening after a stable pneumoperitoneum was established via transumbilical access. In the remaining 24 cases, the access to the abdominal cavity was obtained by direct insertion of a 12-mm trocar transvaginally, without a previous pneumoperitoneum. The transvaginal access was sutured closed in all cases via a standard colposcope.

In most hybrid NOTES procedures, the transabdominal trocar was used for introducing instruments for dissection, with the exception of the transvaginal approach, which used modified TEM instrumentation with the transabdominal trocar only used to obtain a safe and clear transvaginal access. The TEM instrumentation consists of a 50-cm-long and 33-mm diameter dedicated colposcope through which four dedicated extra-long instruments were used for tissue manipulation, dissection, and suturing.

Conversion to traditional laparoscopy was needed in only 3 cases during any of the transvaginal cholecystectomy procedures, not related to the use of flexible or rigid instruments. The reasons for adding one or more trocarswere for better manipulation in 21 cases, while in 2 cases it was to control bleeding, in 2 additional cases it was due to unclear anatomy, and in 1 case because of a large cystic duct.

Overall, transvaginal procedures were faster than transgastric procedures (58.7 min vs. 125.4 min, P < 0.001). Among transvaginal techniques, operative time was significantly shorter in the group with rigid laparoscopes compared to each of the other techniques (P < 0.001).

Table 17.2 summarizes complications and hospital stay for the different cholecystectomy techniques. Eight complications (2.5%) were observed post-operatively. Two complications (1.4%) occurred after transvaginal and transumbilical access with a flexible endoscope. One intra-abdominal hematoma was probably due to the dislodgement of the endoscopic clip on the cystic artery. One complication consisted of minimal vaginal bleeding which was controlled by suture. Five complications (1.8%) occurred post-operatively after transvaginal and transumbilical access with a rigid laparoscope. Two required additional surgery due to a bile leak and a pelvic abscess. Another 2 patients needed postoperative ERCP for a bile leak.