By Monica J. Smith

Baltimore—A recent small study finding that natural orifice transluminal endoscopic surgery (NOTES) through the vagina does not affect sexual function or the patient’s ability to deliver a baby vaginally, and reduces postoperative pain and the risk for complications, may assuage the concerns of some providers and patients.

“NOTES surgery provides an obvious aesthetic advantage and a potential to reduce trocar site complications; still, many potential patients and providers have concerns regarding potential sexual dysfunction and gynecologic problems,” said Garth R. Jacobson, MD, of the University of California, San Diego, who presented his team’s findings at the 2013 meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (abstract S104).

Dr. Jacobson and his colleagues retrospectively evaluated the outcomes of 34 procedures performed using NOTES at their institution between 2007 and 2012, including 34 cholecystectomies, three appendectomies and three sleeve gastrectomies. The patients had a mean age of 40 years (23-63), mean body mass index of 27 kg/m2 (16-43), and an ASA classification of 2 or lower.

The hybrid transvaginal approach consisted of the conventional laparoscopic approach followed by transvaginal organ extraction at the end of the procedure.

“This point we believe is important in NOTES access surgery: Our entry is under direct laparoscopic visualization in order to prevent complications,” Dr. Jacobson said.

After dilating the patient’s cervix and inserting a uterine mobilizer, the surgeons place a 15-mm trocar in the posterior cul-de-sac of the vagina under direct view. Then they place an endoscope through the vaginal trocar along with a snare for organ extraction. Once the extraction is complete, the defect is closed with a single figure-of-eight absorbable stitch.

Operative times in this series were 93, 78 and 132 minutes, respectively, for cholecystectomy, appendectomy and sleeve gastrectomy. A single-night hospital stay was mandated by the institutional review board, and length of stay averaged one night. There were no re-operations, conversions or deaths, and the complications that occurred in six patients (18%) were relatively minor, consisting of spotting or heavy menses, which were successfully treated by conventional means.

Notably, using a visual analog scale to rate pain, with zero being no pain and 10 being worst pain, patients reported almost no pain by the end of the first week. During the mean follow-up period of 18 months, there were no trocar site–related complications, no sexual dysfunction or dyspareunia, and two patients became pregnant and had successful vaginal deliveries.

“Our initial experience with transvaginal organ extraction suggests the approach is safe and effective and without pelvic organ dysfunction in the short term. The operation has the potential to improve upon postoperative pain, trocar site complication infections and herniations,” Dr. Jacobson said, noting that further evaluations from randomized studies, such as the NOSCAR trial, and long-term follow-up are needed to corroborate their findings.

“The data presented by the San Diego group are certainly encouraging, and reflect that the introduction of NOTES has been a thoughtful and methodical process where investigators have enrolled patients on IRB-approved protocols,” said Steve D. Schwaitzberg, MD, chief of surgery, Cambridge Health Alliance; associate professor of surgery, Harvard Medical School, Boston; and co-principal investigator, NOSCAR prospective randomized trial.

The leadership for this approach is the result of a joint effort between SAGES and the American Society for Gastrointestinal Endoscopy through the development of the NOSCAR consortium, Dr. Schwaitzberg said. “This approach has led to careful study, first in the laboratory and then in the clinical milieu,” a model that has continued to be followed worldwide.

“Despite the need for better funding and a coordinated streamlined pathway, the approach taken by the leading medical and surgical societies in this realm should be considered a success and the model for the responsible introduction of future innovation,” Dr. Schwaitzberg said.

He noted that regardless of outcomes of any NOTES trials, it would be but one alternative to the minimally invasive treatment of disease. “Some women are simply not interested in transvaginal access; transgastric access still needs more development,” he said.