Borchert Dietmar H, Federlein Matthias, Fritze-Büttner Frauke, Burghardt Jens, Liersch-Löhn Britta, Atas Yüksel, Müller Verena, Rückbeil Oskar, Wagenpfeil Stefan, Gräber Stefan, Gellert Klaus
Department of General, Visceral, Vascular and Pediatric Surgery, and Institute of Biometry, Epidemiology and Medical Informatics, Saarland University Hospitals, Kirrberger Straße 100, 66421, Homburg, Saarland, Germany,
Surg Endosc. 2014 Jun;28(6):1886-94. doi: 10.1007/s00464-013-3409-2. Epub 2014 Jan 24.
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.
经自然腔道内镜手术（NOTES）有可能减轻术后疼痛。我们比较了经阴道视频辅助胆囊切除术（TVC）这种混合NOTES手术与标准传统腹腔镜胆囊切除术（CLC）的术后疼痛情况。
2008年6月至2012年6月在一家二级医院进行的单中心、双盲、随机对照试验。
年龄大于18岁且有症状性胆囊结石的女性患者被随机分为接受TVC或CLC治疗。随访期为7天，研究的主要结局是术后疼痛。我们假设术后48小时内休息或咳嗽时疼痛（视觉评分量表≥1）无减轻。次要结局包括伤口感染、并发症及患者报告的结局。装有计算机生成随机化信息的密封信封留存于手术室用于分配。所有患者均接受不透明伤口敷料，如同标准四孔胆囊切除术及阴道填塞。术后手术流程记录和手术笔记分开保存。
总体而言，426名评估参与的患者中有97名被随机分配接受TVC或CLC治疗。共有41例患者接受TVC，51例接受CLC。5例患者被排除在分析之外。年龄、体重指数、美国麻醉医师协会（ASA）分级或住院时间方面无差异，但TVC的麻醉和手术时间显著更长（p < 0.001）。两组患者休息或咳嗽时术后疼痛无统计学差异。并发症包括中转开腹、出血、伤口感染及再次入院。两组并发症发生率未见差异。总体而言，CLC和TVC患者分别有86%和93%会向其他患者推荐该手术。
本研究中，两种方法术后第1天和第2天的疼痛无显著差异。TVC的安全性与CLC相当，且TVC患者一般会向其他患者推荐该手术。
