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OptiBra 研究,一项关于乳腺癌手术后最佳术后胸罩支持的随机对照试验。

OptiBra study, a randomized controlled trial on optimal postoperative bra support after breast cancer surgery.

机构信息

Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden; Department of Breast, Endocrine and Sarcoma Surgery, Karolinska University Hospital, Stockholm, Sweden.

Department of Breast, Endocrine and Sarcoma Surgery, Karolinska University Hospital, Stockholm, Sweden.

出版信息

Eur J Oncol Nurs. 2023 Apr;63:102285. doi: 10.1016/j.ejon.2023.102285. Epub 2023 Feb 15.

Abstract

AIM

This randomized controlled trial aimed to compare two different postoperative bras after breast cancer surgery and evaluate their impact on primary outcome pain.

METHOD

The study included 201 patients scheduled for primary surgery (breast conserving surgery with sentinel node biopsy or axillary clearance, mastectomy, or mastectomy with primary implant reconstruction with sentinel node biopsy or axillary clearance). Participants were randomized to either a soft bra or stable bra with compression. The patients were recommended to use the bra 24 h/day for 3 weeks, record daily pain (NRS), analgesic use and hours of bra use.

RESULTS

Follow up was completed by 184 patients. No significant differences between the arms were found considering pain score over time, neither day 1-14, nor after 3 weeks. Sixty-eight percent of all patients, regardless of randomization, reported pain during the first 14 days. After 3 weeks 46% still reported pain in the operated breast. Among these, patients randomized to the stable bra with compression reported significantly lower pain score than those randomized to the soft bra. Patients who used the stable bra with compression reported significantly higher levels of comfort, sense of security during activity, less difficulty moving the arm, as well as support and stability for the operated breast compared to those using the soft bra.

CONCLUSION

Using a stable bra with compression is the optimal evidence-based choice after breast cancer surgery to reduce remaining pain 3 weeks after surgery, increasing mobility, comfort, and sense of security.

TRIAL REGISTRATION NUMBER

NCT04059835 at www.

CLINICALTRIALS

gov.

摘要

目的

本随机对照试验旨在比较乳腺癌手术后两种不同的术后胸罩,并评估它们对主要结局疼痛的影响。

方法

本研究纳入了 201 名计划行原发性手术(保乳手术伴前哨淋巴结活检或腋窝清扫术、乳房切除术或乳房切除术伴前哨淋巴结活检或腋窝清扫术的原发性植入物重建术)的患者。参与者被随机分配至软胸罩或带压缩的稳定胸罩。建议患者在 3 周内每天 24 小时佩戴胸罩,记录每日疼痛(NRS)、镇痛药使用情况和胸罩佩戴时间。

结果

184 例患者完成了随访。考虑到疼痛评分随时间的变化,在第 1-14 天和 3 周后,两组之间均无显著差异。无论随机分组如何,所有患者中有 68%在最初 14 天内报告有疼痛。3 周后,仍有 46%的患者报告在手术乳房处有疼痛。在这些患者中,与软胸罩相比,随机分配至带压缩的稳定胸罩的患者报告的疼痛评分显著更低。与使用软胸罩的患者相比,使用带压缩的稳定胸罩的患者报告舒适度、活动时的安全感、手臂活动的困难程度、手术乳房的支撑和稳定性显著更高。

结论

在乳腺癌手术后使用带压缩的稳定胸罩是减少术后 3 周内残余疼痛、提高活动度、舒适度和安全感的最佳循证选择。

试验注册号

NCT04059835 在 www.clinicaltrials.gov。

临床试验

NCT04059835。

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