Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250).
Surg Endosc
; 26(12): 3435-41, 2012 Dec.
Article
en En
| MEDLINE
| ID: mdl-22648123
BACKGROUND AND STUDY AIMS: 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. PATIENTS AND 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.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Colecistectomía Laparoscópica
/
Cirugía Endoscópica por Orificios Naturales
Tipo de estudio:
Clinical_trials
/
Observational_studies
Límite:
Adolescent
/
Adult
/
Aged
/
Female
/
Humans
/
Middle aged
Idioma:
En
Revista:
Surg Endosc
Asunto de la revista:
DIAGNOSTICO POR IMAGEM
/
GASTROENTEROLOGIA
Año:
2012
Tipo del documento:
Article
País de afiliación:
España
Pais de publicación:
Alemania