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Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250)

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Abstract

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.

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Disclosures

Drs. J Noguera, A Cuadrado, C Dolz, J Olea, and J García have no conflicts of interest or financial ties to disclose.

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Authors and Affiliations

  1. Instituto Digestivo Médico-Quirúrgico, Instituto Universitario de Investigación en Ciencias de la Salud, Hospital Son Llàtzer, Carretera de Manacor, Km 4, 07198, Palma, Spain

    José F. Noguera, Angel Cuadrado, Carlos Dolz, José M. Olea & Juan C. García

Authors
  1. José F. Noguera
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  2. Angel Cuadrado
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  3. Carlos Dolz
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  4. José M. Olea
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  5. Juan C. García
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Corresponding author

Correspondence to José F. Noguera.

Additional information

Presented at the SAGES 2012 Annual Meeting, March 7- March 10, 2012, San Diego, CA.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Video 1: Transvaginal approach for hybrid NOTES cholecystectomy (WMV 13748 kb)

Video 2: Transumbilical approach for hybrid NOTES cholecystectomy. (WMV 14107 kb)

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Noguera, J.F., Cuadrado, A., Dolz, C. et al. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc 26, 3435–3441 (2012). https://doi.org/10.1007/s00464-012-2359-4

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