NOTES Not Ready for Widespread Use

Note to Surgeons: NOTES Not Ready for Widespread Use

Daniel M. Keller, PhD

October 7, 2010 (Washington, DC) — Natural orifice translumenal endoscopic surgery (NOTES) is not ready for prime time. That was the overwhelming consensus of a roomful of surgeons gathered here at a session of the American College of Surgeons 96th Annual Clinical Congress. Data presented at the session supported their reluctance to widely adopt the technique just yet. In NOTES, a surgeon inserts an endoscope into a natural orifice and punctures one of the viscera (eg, stomach, vagina, rectum) to access the abdominal cavity and perform an intraabdominal operation. The expected advantages of NOTES are a lower incidence of wound infections, hernias, and adhesions and less pain. Since 2004, authors have reported using the approach for transgastric peritoneoscopy, transgastric appendectomy, and transvaginal cholecystectomy. Despite fast development of the technique and early clinical application, no controlled studies have been carried out. Kai Lehmann, MD, from Charité Hospital in Berlin, Germany, presented results on 1328 patients at 87 hospitals participating in the German National NOTES Registry between March 2008 and September 2010. The registry is an anonymous online database maintained by the German Society for General and Visceral Surgery. The purpose of the registry is the safe introduction of NOTES and early detection of problems, “because we think this is the responsibility of the surgical community,” Dr. Lehmann said. All but 10 of the patients in the registry are women. Most of the operations used hybrid techniques combining a natural orifice approach with a minilaparoscopy. A transvaginal approach was used in 1310 of the operations, transgastric in 4, transrectal in 9, and another approach in 1. Dr. Lehamnn said conversions are an important parameter to judge the success of a new minimally invasive surgery. In the registry, there were 26 conversions to laparoscopy and 12 to laparotomy. Twenty-nine conversions occurred for technical reasons, such as intraabdominal adhesions; 2 for complications; and 7 in which the reasons were not available. There were 22 intraoperative complications, 34 postoperative ones, and no deaths so far. The 2 major intraoperative complications were a rectal injury requiring a Hartmann procedure later and a small bowel injury necessitating segment resection. In addition to minor complications in the postoperative period, there were 2 laparoscopies for pain (without pathological findings) and 1 laparoscopic drainage for an abscess in the pouch of Douglas. The operative time of cholecystectomies was significantly longer as the body mass index of the patient increased and for older patients, and times were shorter for institutions with higher case volumes (all P ≤ .001). The researchers divided the participating hospitals into high- and low-volume institutions, with the “high-volume” category denoting hospitals that had done more than 30 NOTES operations. For cholecystectomies, the high-volume hospitals had an operative time of 57.0 ± 25.1 minutes vs 76.6 ± 25.2 minutes for low-volume hospitals (P < .001). There were no significant associations between complications and case volume, body mass index, or age. In summary, Dr. Lehmann said NOTES is not routine practice, but the registry has documented its clinical application. He said in Germany it is used mainly for hybrid transvaginal cholecystectomy, “with a low complication rate, and it appears that it’s safe even in low-volume centers.” Transgastric operations for appendectomy have recently appeared in the registry, “and this is probably the next important step for the registry,” he noted. After Dr. Lehmann’s presentation, the session moderator, Daniel Jones, MD, MS, chief of minimally invasive surgery at Beth Israel Deaconess Hospital and associate professor of surgery at Harvard Medical School in Boston, Massachusetts, asked for a show of hands of surgeons now performing NOTES and thinking it was a good idea. Fewer than 10 hands went up out of the more than 100 people in the room. There was an overwhelming show of hands of surgeons who would not use the technique at this point. In an interview with Medscape Medical News, Dr. Jones said Dr. Lehmann’s presentation showed that surgeons are taking the lead in developing databases to keep track of outcomes as they accrue. “You also saw early results which showed that you had new complications when you approach laparoscopic cholecystectomy through the vagina,” he said. “That made many in the audience raise their hands and say ‘that’s the data we need to say no to NOTES.’ ” But Dr. Jones pointed out that the real message of the study is that good long-term data are needed as the field makes innovations to “make sure that we are taking care of patients better.” “If [NOTES] is going to be done, it needs to be done on protocols,” Dr Jones stressed. “It needs to be recorded. You don’t want to hide your mistakes and sweep them under the carpet. You want to actually bring them forth so we can think of creative ways to make those problems less.” Dr. Lehmann noted that other NOTES registries are also underway. The new European Health Registry has 320 patients in it, and a South American registry currently includes 650 patients. Dr. Lehmann and Dr. Jones have disclosed no relevant financial relationships. The German Society for General and Visceral Surgery paid Dr. Lehmann for the initial programming of the registry software in 2008. American College of Surgeons 96th Annual Clinical Congress: Session on Bariatric and Foregut Surgery. Presented October 4, 2010.

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