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单孔机器人胆囊切除术与四孔腹腔镜胆囊切除术的短期疗效:一项前瞻性、随机、双盲试验

Short-term outcomes of single-site robotic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective, randomized, double-blind trial.

作者信息

Pietrabissa Andrea, Pugliese Luigi, Vinci Alessio, Peri Andrea, Tinozzi Francesco Paolo, Cavazzi Emma, Pellegrino Eugenia, Klersy Catherine

机构信息

Department of Surgery, Fondazione IRCCS Policlinico San Matteo, Università di Pavia, Pavia, Italy.

Unit of General Surgery 2, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Piazzale Golgi, 19, 27100, Pavia, Italy.

出版信息

Surg Endosc. 2016 Jul;30(7):3089-97. doi: 10.1007/s00464-015-4601-3. Epub 2015 Oct 23.

Abstract

BACKGROUND

Randomized studies could not demonstrate significant outcome benefit after single-incision laparoscopic cholecystectomy compared to classic four-port laparoscopic cholecystectomy (CLC). The new robotic single-site platform might offer potential benefits on local inflammation and postoperative pain due to its technological advantages. This prospective randomized double-blind trial compared the short-term outcomes between single-incision robotic cholecystectomy (SIRC) and CLC.

METHODS

Two groups of 30 eligible patients were randomized for SIRC or CLC. During the first postoperative week, patients and study monitors were blinded to the type of procedure performed by four dressing tapes applied on the abdomen. Pain was assessed at 6 h and on day 1, 7 and 30 after surgery, along with a 1-10 cosmetic score.

RESULTS

No significant difference in postoperative pain occurred in the two groups at any time point nor for any of the abdominal sites. Nineteen (63 %) SIRC patients reported early postoperative pain in extra-umbilical sites. Intraoperative complications which might influence postoperative pain, such as minor bleeding and bile spillage, were similar in both groups and no conversions occurred. The cosmetic score 1 month postoperatively was higher for SIRC (p < 0.001). Two SIRC patients had wound infection, one of which developed an incisional hernia.

CONCLUSIONS

SIRC does not offer any significant reduction of postoperative pain compared to CLC. SIRC patients unaware of their type of operation still report pain in extra-umbilical sites like after CLC. The cosmetic advantage of SIRC should be balanced against an increased risk of incisional hernias and higher costs.

TRIAL REGISTRATION NUMBER

ACTRN12614000119695 ( http://www.anzctr.org.au ).

摘要

背景

与传统四孔腹腔镜胆囊切除术(CLC)相比,随机研究未能证明单切口腹腔镜胆囊切除术具有显著的预后益处。新型机器人单孔平台因其技术优势,可能在局部炎症和术后疼痛方面带来潜在益处。这项前瞻性随机双盲试验比较了单切口机器人胆囊切除术(SIRC)和CLC的短期预后。

方法

将两组各30例符合条件的患者随机分为SIRC组或CLC组。术后第一周,通过在腹部粘贴四条敷料带,使患者和研究监测人员对所行手术类型不知情。在术后6小时、第1天、第7天和第30天评估疼痛情况,并进行1至10分的美容评分。

结果

两组在任何时间点及腹部任何部位的术后疼痛均无显著差异。19例(63%)SIRC患者报告脐外部位有早期术后疼痛。两组术中可能影响术后疼痛的并发症,如轻微出血和胆汁渗漏情况相似,且均未发生中转。术后1个月SIRC组的美容评分更高(p<0.001)。2例SIRC患者发生伤口感染,其中1例发展为切口疝。

结论

与CLC相比,SIRC并未显著减轻术后疼痛。未意识到手术类型的SIRC患者仍像CLC术后一样报告脐外部位疼痛。SIRC的美容优势应与切口疝风险增加和成本较高相权衡。

试验注册号

ACTRN12614000119695(http://www.anzctr.org.au)

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