First US surgery to compare NOTES vs. laparoscopy

July 7, 2010, University of California - San Diego

As part of the only U.S. prospective multicenter clinical trial to compare natural orifice translumenal endoscopic surgery (NOTES) to laparoscopy, surgeons at the University of California, San Diego School of Medicine have performed the trial's first oral gallbladder removal. This landmark study will evaluate whether or not NOTES is safe and as effective as traditional laparoscopic surgery.

"This groundbreaking study is the first in the world to compare oral and transvaginal NOTES to traditional ," said Santiago Horgan, MD, principal investigator of the UCSD study site and chief of minimally at UC San Diego Health System. "Laparoscopy first emerged in the late 1980's. Two decades later, we are evaluating NOTES ─ a technologically-advanced surgical technique that may one day allow lifesaving with no external incisions."

This study uses the mouth and vagina as routes to the . Rather than creating up to five incisions in the abdominal wall, tools are passed down the mouth and through a hole created in the stomach (transgastric) or through the vagina (transvaginal). Under this clinical trial protocol, a laparoscopic port is required. Horgan opted to make two tiny incisions, requiring no stitches, to pass a camera and to inflate the abdomen for optimal safety and visibility. The actual gallbladder removal was performed entirely through the mouth.

"What is unique about this trial is that we will not only evaluate the safety and efficacy of NOTES compared to laparoscopy but will also assess and compare pain levels, cosmetic outcomes, operative costs and logistical outcomes," said Horgan, who has performed more than 70 NOTES surgeries.

Horgan, director of UCSD's Center for the Future of Surgery, said that traditional laparoscopy is a highly effective technique but that there is always room for improvement in reducing post-operative infection, hernia, scarring and pain.

"We hypothesize that NOTES procedures may reduce pain and infection by eliminating abdominal wall incisions altogether," said Horgan. "Post-operatively, many patients experience pain while walking or coughing due to contraction of the abdominal muscles. This discomfort is absent following the natural orifice approach."

On a randomized basis, up to 200 patients will be enrolled in the clinical trial to obtain 70 NOTES cases (35 transgastric and 35 transvaginal) and 70 laparoscopic cases. The UCSD site plans to enroll 20 patients.

Cholecystectomy, or gallbladder removal, is one of the most common surgeries in the United States, performed on approximately 750,000 patients per year.

Related Stories

Recommended for you

Best of Last Year—The top Medical Xpress articles of 2017

December 20, 2017
It was a good year for medical research as a team at the German center for Neurodegenerative Diseases, Magdeburg, found that dancing can reverse the signs of aging in the brain. Any exercise helps, the team found, but dancing ...

Pickled in 'cognac', Chopin's heart gives up its secrets

November 26, 2017
The heart of Frederic Chopin, among the world's most cherished musical virtuosos, may finally have given up the cause of his untimely death.

Sugar industry withheld evidence of sucrose's health effects nearly 50 years ago

November 21, 2017
A U.S. sugar industry trade group appears to have pulled the plug on a study that was producing animal evidence linking sucrose to disease nearly 50 years ago, researchers argue in a paper publishing on November 21 in the ...

Female researchers pay more attention to sex and gender in medicine

November 7, 2017
When women participate in a medical research paper, that research is more likely to take into account the differences between the way men and women react to diseases and treatments, according to a new study by Stanford researchers.

Drug therapy from lethal bacteria could reduce kidney transplant rejection

August 3, 2017
An experimental treatment derived from a potentially deadly microorganism may provide lifesaving help for kidney transplant patients, according to an international study led by investigators at Cedars-Sinai.

Exploring the potential of human echolocation

June 25, 2017
People who are visually impaired will often use a cane to feel out their surroundings. With training and practice, people can learn to use the pitch, loudness and timbre of echoes from the cane or other sounds to navigate ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.