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随机临床试验比较原发性甲状旁腺功能亢进的开放手术与电视辅助微创甲状旁腺手术。

Randomized clinical trial comparing open with video-assisted minimally invasive parathyroid surgery for primary hyperparathyroidism.

机构信息

Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.

出版信息

Br J Surg. 2010 Feb;97(2):177-84. doi: 10.1002/bjs.6810.

Abstract

BACKGROUND

: Previous studies of video-assisted techniques for parathyroidectomy in patients with primary hyperparathyroidism have found similar or better results compared with bilateral neck exploration. The aim of the present study was to compare open minimally invasive parathyroidectomy with the video-assisted technique for primary hyperparathyroidism in a multicentre randomized trial.

METHODS

: Some 143 patients were randomized to open (n = 75) or video-assisted (n = 68) parathyroidectomy after positive sestamibi scintigraphy. There were no differences in preoperative data. The open operation was performed through a 15-mm incision. The video-assisted techniques used were minimally invasive video-assisted parathyroidectomy (MIVAP) or video-assisted parathyroidectomy using the lateral approach (VAPLA). Data were collected prospectively including postoperative pain scoring.

RESULTS

: The procedure was significantly quicker for the open compared to the video assisted operations: mean(s.d.) 60(35) versus 84(47) min (P = 0.001). Both groups of patients had similar conversion rates and the same outcome, with comparable incision lengths, low scores for postoperative neck discomfort, high cosmetic satisfaction and low complication rates.

CONCLUSION

: Open minimally invasive parathyroidectomy for primary hyperparathyroidism was quicker than either video-assisted technique.

REGISTRATION NUMBER

NCT00877981 (http://www.clinicaltrials.gov)

摘要

背景

先前对原发性甲状旁腺功能亢进症患者行甲状旁腺切除术的视频辅助技术研究发现,与双侧颈部探查相比,其结果相似或更好。本研究旨在通过多中心随机试验比较开放式微创甲状旁腺切除术与视频辅助技术治疗原发性甲状旁腺功能亢进症。

方法

对经放射性核素扫描证实为阳性的 143 例患者进行随机分组,分别行开放式(n=75)或视频辅助(n=68)甲状旁腺切除术。术前数据无差异。开放式手术采用 15mm 切口。视频辅助技术包括微创视频辅助甲状旁腺切除术(MIVAP)或侧方入路视频辅助甲状旁腺切除术(VAPLA)。前瞻性收集数据,包括术后疼痛评分。

结果

与视频辅助手术相比,开放式手术时间明显缩短:(均数±标准差)60(35)分钟对 84(47)分钟(P=0.001)。两组患者的转化率和手术结果相似,切口长度相当,术后颈部不适评分较低,美容满意度高,并发症发生率低。

结论

对于原发性甲状旁腺功能亢进症,开放式微创甲状旁腺切除术比任何一种视频辅助技术都更快。

注册号

NCT00877981(http://www.clinicaltrials.gov)

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