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单孔与传统腹腔镜完全腹膜外腹股沟疝修补术:一项前瞻性、随机、对照临床试验。

Single-port versus conventional laparoscopic total extra-peritoneal inguinal hernia repair: a prospective, randomized, controlled clinical trial.

作者信息

Wijerathne Sujith, Agarwal Narendra, Ramzi Ahmad, Liem Dino H, Tan Wee B, Lomanto Davide

机构信息

Department of Surgery, Minimally Invasive Surgical Centre, National University Health System, Singapore, Singapore.

Department of General Surgery, National University Health System, NUHS Tower Block, Level 08, 1E, Kent Ridge Road, Singapore, 119228, Singapore.

出版信息

Surg Endosc. 2016 Apr;30(4):1356-63. doi: 10.1007/s00464-015-4378-4. Epub 2015 Jul 11.

Abstract

BACKGROUND

The advantage of single-port total extra-peritoneal (TEP) inguinal hernia repair over the conventional technique is still debatable. Our objective was to compare the outcomes of TEP inguinal hernia repair using either a single-port or conventional surgical technique, in two blind randomized groups of patients.

METHODS

In this prospective, randomized, double-blind, controlled clinical trial, 100 patients undergoing surgery for unilateral inguinal hernia were randomized into two groups: One group underwent conventional laparoscopic TEP inguinal hernia repair, while the other was selected for single-port TEP repair. Primary endpoint is postoperative pain (VAS), while secondary endpoints are recurrence, chronic pain and complications.

RESULTS

From 100 patients, 49 underwent single-port hernia TEP repair, 50 had conventional three-port TEP hernia repair, and one patient declined to participate after randomization. The two groups were comparable in terms of patient demographics and operative findings. Mean operative time was 49.1(±13.8) min in the conventional group and 54.1(±14.4) min in the single-port group (p = 0.08). Mean hospital stay was 19.7(±5.8) h in the conventional group and 20.5(±6.4) h in the single-port group (p = 0.489). No major complications and no recurrence reported at 11-month follow-up. No statistically significant difference noted in postoperative pain between the two groups at regular intervals.

CONCLUSIONS

The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are similar but not superior to the conventional technique.

摘要

背景

单孔全腹膜外(TEP)腹股沟疝修补术相对于传统技术的优势仍存在争议。我们的目的是在两组随机双盲患者中比较采用单孔或传统手术技术进行TEP腹股沟疝修补术的效果。

方法

在这项前瞻性、随机、双盲、对照临床试验中,100例接受单侧腹股沟疝手术的患者被随机分为两组:一组接受传统腹腔镜TEP腹股沟疝修补术,另一组接受单孔TEP修补术。主要终点是术后疼痛(视觉模拟评分法[VAS]),次要终点是复发、慢性疼痛和并发症。

结果

100例患者中,49例行单孔疝TEP修补术,50例行传统三孔TEP疝修补术,1例患者在随机分组后拒绝参与。两组在患者人口统计学和手术结果方面具有可比性。传统组平均手术时间为49.1(±13.8)分钟,单孔组为54.1(±14.4)分钟(p = 0.08)。传统组平均住院时间为19.7(±5.8)小时,单孔组为20.5(±6.4)小时(p = 0.489)。11个月随访时未报告重大并发症和复发情况。两组在术后不同时间点的疼痛程度无统计学显著差异。

结论

使用单孔器械进行腹腔镜TEP腹股沟疝修补术的效果与传统技术相似,但并不优于传统技术。

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