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首页> 外文期刊>Surgical Endoscopy >Postoperative pain after transvaginal cholecystectomy: Single-center, double-blind, randomized controlled trial
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Postoperative pain after transvaginal cholecystectomy: Single-center, double-blind, randomized controlled trial

机译：经阴道胆囊切除术后的疼痛：单中心，双盲，随机对照试验

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Background: 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). Design: Single-center, double-blind, randomized controlled trial in a level II hospital between June 2008 and June 2012. Methods: 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. Results: 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. Conclusion: 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.
机译：背景：自然孔腔内镜手术（NOTES）具有减轻术后疼痛的潜力。我们将混合式NOTES手术经阴道电视辅助胆囊切除术（TVC）与常规常规腹腔镜胆囊切除术（CLC）的术后疼痛进行了比较。设计：2008年6月至2012年6月间在二级医院进行的单中心，双盲，随机对照试验。方法：将18岁以上有症状胆囊结石症的女性患者随机接受TVC或CLC。随访期为7天，研究的主要结果是术后疼痛。我们假设在术后48小时内休息或咳嗽时疼痛没有减轻（视觉评定量表≥1）。次要结果包括伤口感染，并发症和患者报告的结果。带有计算机生成的随机信息的密封信封保留在剧院分配。所有患者均接受不透明的伤口敷料，如标准的四针胆囊切除术和阴道填塞术。手术后，手术方案和手术笔记分开存放。结果：总体上，在426名参与评估的患者中，有97名被随机分配TVC或CLC。共有41例患者接受TVC，51例患者接受CLC。五名患者被排除在分析之外。在年龄，体重指数，美国麻醉医师学会（ASA）等级或住院时间方面没有差异，但TVC的麻醉和手术时间明显更长（p <0.001）。两组在休息或咳嗽时的术后疼痛无统计学差异。并发症包括开腹手术，出血，伤口感染和再次入院。两组之间的并发症发生率没有差异。总体而言，分别有86％和93％的CLC和TVC患者会推荐该过程给其他患者。结论：在这项研究中，两种方法在术后第1天和第2天疼痛没有显着差异。 TVC的安全性与CLC相当，TVC患者通常会向其他患者推荐该程序。

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