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单孔经脐腹腔镜胆囊切除术:140例临床结果的前瞻性随机对照研究

Single-port transumbilical laparoscopic cholecystectomy: A prospective randomised comparison of clinical results of 140 cases.

作者信息

Vilallonga Ramon, Barbaros Umut, Sümer Aziz, Demirel Tuğrul, Fort José Manuel, González Oscar, Rodriguez Nivardo, Carrasco Manuel Armengol

机构信息

Department of General Surgery, Universitary Hospital Vall d'Hebron, Barcelona, Spain.

出版信息

J Minim Access Surg. 2012 Jul;8(3):74-8. doi: 10.4103/0972-9941.97586.

DOI:10.4103/0972-9941.97586
PMID:22837593
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3401720/
Abstract

INTRODUCTION

A novel single port access (SPA) cholecystectomy approach is described in this study. We have designed a randomised comparative study in order to elucidate any possible differences between the standard treatment and this novel technique.

MATERIALS AND METHODS

Between July 2009 and March 2010, 140 adult patients with gallbladder pathologies were enrolled in this multicentre study. Two surgeons (RV and UB) randomised patients to either a standard laparoscopic (SL) approach group or to an SPA cholecystectomy group. Two types of trocars were used for this study: the TriPort™ and the SILS™ Port. Outcomes including blood loss, operative time, complications, length of stay and pain were recorded.

RESULTS

There were 69 patients in the SPA group and 71 patients in the SL group. The mean age of the patients was 43.2 (17-77) for the SPA group and 42.6 (19-70) for the SL group. The mean operative time was 63.9 min in the SPA group and 58.4 min in the SL group. For one patient, the SPA procedure was converted to a standard laparoscopic technique and to open approach in the SL group. Complications occurred in eight patients: Five seromas (two in the SPA group) and three hernias (one in the SPA group).The mean hospital stay was 38.5 h in the SPA group and 24.1 h in the SL group. Pain was evaluated and was 2 in the SPA and 2.9 in the SL group, according to the visual analogue scale (VAS) after 24 h (P<0.001). The degree of satisfaction was higher in the SPA group (8.3 versus 6.7). Similar results were found for the aesthetic result (8.8 versus 7.5). (P<0.001).

CONCLUSION

Single-port transumbilical laparoscopic cholecystectomy can be feasible and safe. When technical difficulties arise, early conversion to a standard laparoscopic technique is advised to avoid serious complications. The SPA approach can be undertaken without the expense of additional operative time and provides patients with minimal scarring. The cosmetic results and the degree of satisfaction appear to be significant for the SPA approach.

摘要

引言

本研究描述了一种新型单孔入路(SPA)胆囊切除术方法。我们设计了一项随机对照研究,以阐明标准治疗与这种新技术之间可能存在的差异。

材料与方法

2009年7月至2010年3月期间,140例患有胆囊疾病的成年患者被纳入这项多中心研究。两名外科医生(RV和UB)将患者随机分为标准腹腔镜(SL)入路组或SPA胆囊切除术组。本研究使用了两种类型的套管针:TriPort™和SILS™ Port。记录的结果包括失血量、手术时间、并发症、住院时间和疼痛情况。

结果

SPA组有69例患者,SL组有71例患者。SPA组患者的平均年龄为43.2岁(17 - 77岁),SL组为42.6岁(19 - 70岁)。SPA组的平均手术时间为63.9分钟,SL组为58.4分钟。在SPA组中,有1例患者的手术转为标准腹腔镜技术,在SL组中有1例转为开放手术。8例患者出现并发症:5例血清肿(SPA组2例)和3例疝气(SPA组1例)。SPA组的平均住院时间为38.5小时,SL组为24.1小时。术后24小时根据视觉模拟量表(VAS)评估疼痛,SPA组为2分,SL组为2.9分(P < 0.001)。SPA组的满意度更高(8.3对6.7)。美容效果方面也有类似结果(8.8对7.5)(P < 0.001)。

结论

单孔经脐腹腔镜胆囊切除术可行且安全。出现技术困难时,建议尽早转为标准腹腔镜技术以避免严重并发症。SPA入路不会增加额外手术时间,且给患者留下的疤痕最小。对于SPA入路,美容效果和满意度似乎都很显著。

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