Postoperative pain after transvaginal cholecystectomy: single-center, double-blind, randomized controlled trial
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Natural orifice transluminal endoscopic surgery (NOTES) has the potential to reduce postoperative pain. We compared postoperative pain in the hybrid NOTES procedure transvaginal video-assisted cholecystectomy (TVC) with standard conventional laparoscopic cholecystectomy (CLC).
Single-center, double-blind, randomized controlled trial in a level II hospital between June 2008 and June 2012.
Female patients, older than 18 years of age with symptomatic cholecystolithiasis were randomized to receive either TVC or CLC. The follow-up period was 7 days and the primary outcome of the study was postoperative pain. We hypothesized that there is no reduction of pain (Visual Rating Scale ≥1) while resting or coughing over a 48-h period after the operation. Secondary outcome included wound infections, complications, and patient reported outcomes. Sealed envelopes with computer-generated randomization information were kept for allocation in theater. All patients received opaque wound dressing, as in standard four-trocar cholecystectomy and a vaginal tamponade. Theater protocol and surgical notes were kept separate after the procedure.
Overall, 97 of 426 patients assessed for participation were randomized for either TVC or CLC. A total of 41 patients had a TVC and 51 had a CLC. Five patients were excluded from the analysis. There was no difference in age, body mass index, American Society of Anesthesiologists (ASA) grade, or hospital stay, but anesthetic and surgical times were significantly longer in TVC (p < 0.001). There was no statistical difference in postoperative pain between the two groups while resting or coughing. Complications included conversion to laparotomy, bleeding, wound infections, and re-admission. No difference in the rate of complications between the two groups was seen. Overall, 86 and 93 % of CLC and TVC patients, respectively, would recommend the procedure to other patients.
In this study, no significant difference in pain on days 1 and 2 postoperatively between the two methods was found. The safety profile of TVC is comparable to CLC, and TVC patients would generally recommend this procedure to other patients.
KeywordsCholecystectomy NOTES Endoscopy Quality of life SF-36 GIQoL
Dietmar H. Borchert, Matthias Federlein, Frauke Fritze-Büttner, Jens Burghardt, Britta Liersch-Löhn, Yüksel Atas, Verena Müller, Oskar Rückbeil, Stefan Wagenpfeil, Stefan Gräber, and Klaus Gellert have no conflicts of interest or financial ties to disclose.
Charité Ethics Committee approval was received on 16 April 2008 (no. EA1/035/08); the trial started on 2 June 2008 and ended on 11 June 2012; International Standard Randomized Controlled Trial Number (ISRCTN) application was made on 10 October 2008, and an ISRCTN number was assigned on 30 December 2008 (no. 14307590).
Equipment used in the study was partially sponsored by Olympus Inc. No other funding was received, although this was a hospital-sponsored trial.
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