Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250).
OBJECTIVE
Natural orifice transluminal endoscopic surgery (NOTES) is a technique still in experimental development whose safety and effectiveness call for assessment through clinical trials. In this paper we present a three-arm, noninferiority, prospective randomized clinical trial of 1 year duration comparing the vaginal and transumbilical approaches for transluminal endoscopic surgery with the conventional laparoscopic approach for elective cholecystectomy.


METHODS
Sixty female patients between the ages of 18 and 65 years who were eligible for elective cholecystectomy were randomized in a ratio of 1:1:1 to receive hybrid transvaginal NOTES (TV group), hybrid transumbilical NOTES (TU group) or conventional laparoscopy (CL group). The main study variable was parietal complications (wound infection, bleeding, and eventration). The analysis was by intention to treat, and losses were not replaced.


RESULTS
Cholecystectomy was successfully performed on 94% of the patients. One patient in the TU group was reconverted to CL owing to difficulty in maneuvering the endoscope. After a minimum follow-up period of 1 year, no differences were noted in the rate of parietal complications. Postoperative pain, length of hospital stay, and time off from work were similar in the three groups. No patient developed dyspareunia. Surgical time was longer among cases in which a flexible endoscope was used (CL, 47.04 min; TV, 64.85 min; TU, 59.80 min).


CONCLUSIONS
NOTES approaches using the flexible endoscope are not inferior in safety or effectiveness to conventional laparoscopy. The transumbilical approach with flexible endoscope is as effective and safe as the transvaginal approach and is a promising, single-incision approach.
Instituto Universitario de Investigación en Ciencias de la Salud, Hospital Son Llàtzer, Carretera de Manacor, Km 4, 07198, Palma, Spain. drjfnoguera@hotmail.com
José F
JF
Noguera
Angel
A
Cuadrado
Carlos
C
Dolz
José M
JM
Olea
Juan C
JC
García
D000293:Adolescent; D000328:Adult; D000368:Aged; D017081:Cholecystectomy, Laparoscopic / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D057605:Natural Orifice Endoscopic Surgery; D011446:Prospective Studies; D014472:Umbilicus; D014621:Vagina; D055815:Young Adult