Surgeons from the Legacy Health System in Portland, Oregon, and Northwestern University in Chicago, Illinois, reported on the first 7 transgastric natural orifice transluminal surgery (NOTES) cholecystectomies ever performed on humans here at the Society of American Gastrointestinal and Endoscopic Surgeons 2008 Annual Scientific Session and Postgraduate Course.
The thinking behind the NOTES approach is that by using the body’s orifices to get close to target organs, the surgeon can perforate the internal tissue barriers to these organs. Patients would experience no external scarring and much diminished levels of pain.
Until now, most NOTES operations performed on humans have been transvaginal. However, as Nathaniel Soper, MD, chair of surgery at Northwestern University and coprincipal investigator of the study, told Medscape General Surgery, this is simply “not applicable to half the population.” He added that some women are uncomfortable with transvaginal procedures. In addition, he observed that because the stomach is a naturally sterile area, “going through the stomach makes more sense than going through, for example, the rectum.”
Because the use of NOTES for cholecystectomy is in such an early stage of development, the study’s institutional review board (IRB) required that each patient have at least 1 laparoscopic port to monitor the procedure’s safety and to assess that the hole in the stomach was closed securely.
Dr. Soper said that the IRB required that patients stay in hospital overnight but that these surgeries could have been outpatient procedures. In addition, most of the patients did not require any pain medication. The pain that patients did experience was located around the laparoscopic ports.
The session moderator, C. Daniel Smith, MD, FACS, chair of the Department of Surgery, Mayo Clinic, Jacksonville, Florida, is a NOTES skeptic. Although he acknowledged to Medscape General Surgery that the study was well designed and that the patients enrolled did not experience any significant complications, he noted that the sample size was too small to come to any conclusion about how NOTES compares with laparoscopic surgery. In fact, Dr. Smith observed that the obstacles to proving NOTES superior to the laparoscopic approach will be high.
“[Patients who undergo] laparoscopic procedures,” Dr. Smith noted, “have such a short length of stay in the hospital and such a favorable recovery in terms of pain, it may take a huge number of patients to show even minor improvements.”
Dr. Smith doubts that surgeons will have a compelling reason to switch to NOTES, because right now they have a readily available procedure with “exceptionally good outcomes.”
However, Dr. Smith conceded that if NOTES can access places, such as the upper chest wall, that laparoscopic techniques cannot, then NOTES will have real value.
Lee Swanström, MD, PhD, from Legacy Health System, the study’s other principal investigator, told the session that twice as many patients volunteered for the study as were accepted. One reason for patient exclusion was mental stability. He noted that the chances of instability in patients who learn of a study through the Internet can be high and mentioned that the study was looking for more funding because insurance companies are refusing coverage to Oregon patients.
This study was funded by various insurance companies, USGI, Covidien, Power Medical, Karl Storz Endoscopy America, and Ethicon Endo-Surgery Inc, who assisted in the laboratory. Dr. Soper has received funding from Covidien and has been on the ethical advisory boards of Covidien, Ethicon Endo-Surgery Inc, and USGI Medical. Dr. Smith has disclosed no relevant financial relationships. Dr. Swanström receives research support from USGI Medical, Boston Scientific, and Olympus Surgical America; is a consultant with USGI Medical; and was a speaker/teacher for Ethicon Endo-Surgery.
Society of American Gastrointestinal and Endoscopic Surgeons 2008 Annual Scientific Session and Postgraduate Course: Abstract S034. Presented April 9–12, 2008.
Reviewed By Dr. Ramaz MItaishvili
