Subjects: R and D
Surgeons at UC San Diego have removed a woman’s gallbladder through her mouth. The procedure, known as natural orifice translumenal endoscopic surgery (NOTES), was performed as part of a prospective multicenter clinical trial designed to compare it with laparoscopy.
Soon after laparoscopy was introduced in the 1980s, it became the technique of choice for gallbladder removal (cholecystectomy), because it was associated with reduced costs and morbidity.
Typically, laparoscopic cholecystectomy requires creating 3-5 incisions in the abdominal wall. In contrast, NOTES involves accessing the gallbladder through the mouth and a subsequent a hole created in the stomach (the so-called transgastric approach). An alternative NOTES procedure accesses the gallbladder through the vagina (the transvaginal approach).
“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 Santiago Horgan a principal investigator in the study and chief of minimally invasive surgery at UCSD Health System. Horgan has performed more than 70 NOTES surgeries.
Horgan said that traditional laparoscopy is highly effective, but suggested the newer approach might reduce post-operative infection, hernia, scarring and pain.
“We hypothesize that NOTES procedures may reduce pain and infection by eliminating abdominal wall incisions altogether,” Horgan explained. “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.”
The trial is designed to perform 70 NOTES cases (35 transgastric and 35 transvaginal) and 70 laparoscopic cases. The UCSD site plans to enroll 20 patients.
Cholecystectomy is one of the most common surgeries in the US. Nearly 750,000 patients undergo the procedure each year.