Transvaginal/Transumbilical Hybrid-NOTES-Versus 3-Trocar Needlescopic Cholecystectomy: Short-term Results of a Randomized Clinical Trial
Transvaginal/Transumbilical Hybrid-NOTES-Versus 3-Trocar Needlescopic Cholecystectomy: Short-term Results of a Randomized Clinical Trial
复制标题
DOI：
10.1097/sla.0000000000000218
复制
发表时间：
2015-03-01
影响因子：
9
通讯作者：
Heiss, Markus Maria
中科院分区：
文献类型：
--
作者：
Bulian, Dirk Rolf;Knuth, Juergen;Heiss, Markus Maria
目的：对于胆囊切除术，使用2至3 mm套管针的针式胆囊切除术（NC）3套管技术和脐辅助经阴道胆囊切除术（TVC）技术均已进入临床常规。本研究比较了这两种技术在女性患者谁是在需要一个择期cholecystectomy.Background：自然腔道经腔内镜手术（NOTES）是一种外科概念，允许无瘢痕的腹腔内手术通过自然孔，如阴道。由于缺乏足够的动力试验，我们设计了这第一个随机对照研究比较TVC和NC.Methods：这一前瞻性，随机，非盲，单中心试验评估的安全性和有效性TVC（干预），与NC（对照）在女性患者有症状的胆囊结石。主要终点为术后第2天（POD）早晨的疼痛强度。次要结局包括术中和术后并发症、手术时间、镇痛剂用量、术后第10天的疼痛强度、住院时间、对美容结果的满意度以及术后第10天的生活质量（使用Eypasch胃肠生活质量指数（GIQLI）进行量化）。在2010年2月至2012年6月期间，40名患者被随机分配到干预组或对照组。所有患者均完成随访。两组的手术时间、术后住院时间以及术中和术后并发症发生率相似。然而，尽管外周镇痛药的使用显著较少（P = 0.019），但经阴道入路在术后第2天和术后第10天的疼痛方面具有显著优势（P = 0.043 vs P = 0.010）。在TVC组中，患者对美学结果的满意度明显更高（P < 0.001），GIQLI明显更好（P = 0.028）。结论：尽管在安全性方面相当，但TVC引起的疼痛更少，对美学结果的满意度增加，并在短期内改善了术后生活质量。
Objective: For cholecystectomy, both the needlescopic cholecystectomy (NC) 3-trocar technique using 2 to 3 mm trocars and the umbilical-assisted transvaginal cholecystectomy (TVC) technique have found their way into clinical routine. This study compares these 2 techniques in female patients who are in need of an elective cholecystectomy.Background: Natural orifice transluminal endoscopic surgery (NOTES) is a surgical concept permitting scarless intra-abdominal operations through natural orifices, such as the vagina. Because of the lack of an adequately powered trial, we designed this first randomized controlled study for the comparison of TVC and NC.Methods: This prospective, randomized, nonblinded, single-center trial evaluates the safety and effectiveness of TVC (intervention), compared with NC (control) in female patients with symptomatic cholecystolithiasis. The primary endpoint was intensity of pain until the morning of postoperative day (POD) 2. Secondary outcomes were among others intra-and postoperative complications, procedural time, amount of analgesics used, pain intensity until POD 10, duration of hospital stay, satisfaction with the aesthetic result, and quality of life on POD 10 as quantified with the Eypasch Gastrointestinal Quality of Life Index (GIQLI).Results: Between February 2010 and June 2012, 40 patients were randomly assigned to the interventional or control group. All patients completed follow-up. Procedural time, length of postoperative hospital stay, and the rate of intra-and postoperative complications were similar in the 2 groups. However, significant advantages were found for the transvaginal access regarding pain until POD 2, but also until POD 10 (P = 0.043 vs P = 0.010) despite significantly less use of peripheral analgesics (P = 0.019). In the TVC group, patients were significantly more satisfied with the aesthetic result (P < 0.001) and had a significantly better GIQLI (P = 0.028).Conclusions: Although comparable in terms of safety, TVC caused less pain, increased satisfaction with the aesthetic result, and improved postoperative quality of life in the short term.