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随机临床试验比较了有和无侧方止血缝线的冷刀宫颈锥切术。

Randomized clinical trial comparing cold knife conization of the cervix with and without lateral hemostatic sutures.

机构信息

Universidade Federal do Rio Grande do Sul (PPGCM-UFRGS), Porto Alegre, Brazil.

Gynecologic Oncology Department, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.

出版信息

Int J Surg. 2015 Jun;18:224-9. doi: 10.1016/j.ijsu.2015.04.081. Epub 2015 Apr 30.

DOI:10.1016/j.ijsu.2015.04.081
PMID:25937157
Abstract

OBJECTIVE

Compare blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures in the cervical branches of the uterine arteries.

DESIGN

Randomized clinical trial.

SETTING

Hospital de Clínicas de Porto Alegre (HCPA).

POPULATION

102 patients that underwent cold knife conization.

METHODS

Women that underwent cold knife conization of the cervix were randomized to undergo the procedure with or without lateral hemostatic sutures.

PRIMARY OUTCOME MEASURE

blood loss measured in grams.

SECONDARY OUTCOME MEASURES

operative time and postoperative intervention. Only the participants were blinded to group assignment.

RESULTS

From March 2009 to August 2012, patients were randomly assigned to one of the study groups. There were no differences in amount of blood loss between patients that underwent the procedure with and without sutures (p = 0.39). Operative time was shorter in the group without suture (p = 0.020). There were no differences in intervention due to bleeding (p = 0.20). Blood loss was greater among menstruating women than for menopausal women (p = 0.011). There were no differences in amount of blood lost between smoking and nonsmoking patients (p = 0.082).

CONCLUSIONS

Lateral hemostatic sutures do not affect the amount of intraoperative bleeding or the number of postoperative interventions. Their use is not necessary because they result in longer operative time, have a higher cost due to the use of suture material and pose the risk of ureter lesion in case the sutures are not placed at a lower position in the cervix. ClinicalTrials. gov identifier: NCT02184975.

摘要

目的

比较在子宫动脉宫颈分支行冷刀锥切术时使用和不使用侧向止血缝线的出血量。

设计

随机临床试验。

地点

阿雷格里港临床医院(HCPA)。

人群

102 例接受冷刀宫颈锥切术的患者。

方法

将接受冷刀宫颈锥切术的女性随机分为行或不行侧向止血缝线的两组。

主要结局指标

以克为单位测量的出血量。

次要结局指标

手术时间和术后干预。只有参与者对分组分配不知情。

结果

2009 年 3 月至 2012 年 8 月,患者被随机分配到研究组之一。行或不行缝线的两组之间出血量无差异(p = 0.39)。无缝线组的手术时间更短(p = 0.020)。因出血干预的差异无统计学意义(p = 0.20)。月经期女性的出血量大于绝经后女性(p = 0.011)。吸烟和不吸烟患者的出血量无差异(p = 0.082)。

结论

侧向止血缝线不会影响术中出血量或术后干预的次数。由于它们会导致手术时间延长、缝线材料使用成本增加以及在缝线未放置在宫颈较低位置时存在输尿管损伤的风险,因此它们的使用并非必要。临床试验.gov 标识符:NCT02184975。

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