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扁桃体切除术后出血:冷剥离术与双极电凝剥离术的前瞻性、随机对照临床试验

Post-tonsillectomy haemorrhage: a prospective, randomized, controlled clinical trial of cold dissection versus bipolar diathermy dissection.

作者信息

Haddow K, Montague M-L, Hussain S S M

机构信息

Department of Otolaryngology, Ninewells Hospital and Medical School, Dundee, UK.

出版信息

J Laryngol Otol. 2006 Jun;120(6):450-4. doi: 10.1017/S0022215106000120. Epub 2006 Jan 27.

Abstract

OBJECTIVE

To determine whether bipolar dissection tonsillectomy is associated with a higher post-operative haemorrhage rate than cold dissection tonsillectomy.

DESIGN

Prospective, randomized, controlled trial.

SETTING

Otolaryngology department of a teaching hospital.

PARTICIPANTS

Two hundred and forty-five patients undergoing elective tonsillectomy between July 2002 and November 2004.

INTERVENTIONS

Patients were randomly assigned to either bipolar dissection or cold dissection (with bipolar haemostasis).

MAIN OUTCOME MEASURES

Post-operative haemorrhage rates, management (conservative or surgical) and blood transfusion requirements were recorded. The grade of surgeon and history of quinsy were also recorded.

RESULTS

One hundred and forty-one patients (58 per cent) were randomized to the bipolar dissection and 104 (42 per cent) to the cold dissection groups. Seventeen patients (12.1 per cent) in the bipolar dissection group and eight patients (7.7 per cent) in the cold dissection group suffered haemorrhage (p = 1.0; degrees of freedom (Df) 0.0; 95 per cent confidence intervals (CI) -0.1 to 0.0). The haemorrhage rates for procedures conducted by senior house officers, specialist registrars and consultants were 11.4 per cent, 10.3 per cent and 5.0 per cent, respectively. Two patients required surgical intervention, both from the bipolar dissection group. No patients required blood transfusion. A history of quinsy was not associated with an increased haemorrhage rate.

CONCLUSION

The difference in haemorrhage rates between groups and surgeon grades did not reach statistical significance. Nonetheless the trend towards a greater incidence of haemorrhage in the bipolar group and in procedures conducted by more junior surgeons during the trial raised concerns. The results of the National Prospective Tonsillectomy Audit and our interim results have led us to abandon the trial and disallow the use of bipolar dissection in tonsillectomies performed by junior staff members.

摘要

目的

确定双极电凝扁桃体切除术与冷剥离扁桃体切除术相比,术后出血率是否更高。

设计

前瞻性、随机、对照试验。

地点

一家教学医院的耳鼻喉科。

参与者

2002年7月至2004年11月期间接受择期扁桃体切除术的245例患者。

干预措施

患者被随机分配接受双极电凝或冷剥离(使用双极止血)。

主要观察指标

记录术后出血率、处理方式(保守或手术)及输血需求。还记录外科医生级别及扁桃体周围炎病史。

结果

141例患者(58%)被随机分配至双极电凝组,104例(42%)被分配至冷剥离组。双极电凝组17例患者(12.1%)发生出血,冷剥离组8例患者(7.7%)发生出血(p = 1.0;自由度(Df)0.0;95%置信区间(CI)-0.1至0.0)。住院医师、专科住院医师和顾问医生进行手术的出血率分别为11.4%、10.3%和5.0%。2例患者需要手术干预,均来自双极电凝组。无患者需要输血。扁桃体周围炎病史与出血率增加无关。

结论

两组间及不同外科医生级别之间的出血率差异未达到统计学显著性。尽管如此,在试验期间双极电凝组及低年资外科医生进行的手术中出血发生率更高的趋势令人担忧。全国前瞻性扁桃体切除术审计结果及我们的中期结果使我们放弃了该试验,并禁止低年资工作人员在扁桃体切除术中使用双极电凝。

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