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临床试验/NCT02159274
NCT02159274已完成不适用

Shoulder Disability and Late Symptoms Following Oncoplastic Breast Surgery

University of Aarhus1 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
408
试验地点
1
主要终点
Shoulder function

研究概览

简要总结

Breast cancer affects a large proportion of Danish women and late morbidity following breast cancer treatment including pain, reduced motility and force of the arm and shoulder, disturbed sensitivity, and lymph edema affects many patients. The risk for such late complications have previously been carefully described by us and others in patients operated by traditional methods, but the follow-up in most of these studies have been rather short , and long time follow-up results are not available. The impact of the new oncoplastic techniques that allows more women to have breast conserving surgery is not known yet. These operations are more extensive and therefore might be accompanied by more complications. The purpose of this study is to give answer to that question.The study includes three parts. First a questionnaire to patients who have breast conserving surgery performed in one of the three breast units in Central Region Denmark. It contains questions regarding arm morbidity, quality of life, comorbidity, and body image. The questionnaire should be filled in preoperatively and 18 months after surgery. The second part consists of an objective evaluation of shoulder and arm function and cosmesis before and after breast conserving surgery with and without oncoplastic techniques. This should be performed at baseline before surgery and 18 months later. The third part is a long time follow-up of patients after breast conserving surgery without oncoplastic techniques. This group of patients is recruited from three breast units in Central Region Denmark. It contains questions regarding arm morbidity, quality of life, comorbidity, and body image. The questionnaire should be filled in preoperatively and 18 months after surgery. The second part consists of an objective evaluation of shoulder and arm function and cosmesis before and after breast conserving surgery with and without oncoplastic techniques. This should be performed at baseline before surgery and 18 months later. The third part is a long time follow-up of patients after breast conserving surgery without oncoplastic techniques. This group of patients is recruited from the cohort in a previous study with 18 months follow-up following breast conserving surgery without oncoplastic technique.

详细描述

Aims and perspectives:

During the last 20 years there has been increasing focus on the morbidity following breast cancer treatment. This has lead to new and less mutilating surgical techniques to replace the traditional operations: Breast conserving surgery (BCS) instead of mastectomy and sentinel lymph node dissection (SLND) instead of axillary lymph node dissection (ALND). Lately, oncoplastic techniques have been introduced. These techniques further increase the ability to preserve the breast in breast cancer and are expected to increase the cosmetic results compared with traditional techniques, but they are somewhat larger procedures and might therefore lead to increased morbidity after treatment. Hitherto this has not been evaluated in clinical research trials.

The aim of the present study is to examine if oncoplastic techniques in relation to breast cancer treatment have an independent influence on morbidity and quality of life compared to traditional BCS.

In addition, a group of breast cancer patients treated with BCS 10 years ago and who underwent a similar study back then, will be invited to a reevaluation of shoulder function and morbidity.

Background:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Invasive breast cancer or carcinoma in situ
  • Breast conserving surgery including or without oncoplastic surgical techniques

排除标准

  • Patients who are unable to sign an informed consent form
  • Patients above the age og 75 and under the age of 18
  • Patients who have previously been operated in the same or the contralateral breast, shoulder or arm

结局指标

主要结局

Shoulder function

时间窗: before and 18 months after surgery

By measuring passive and active range of movement (ROM) in the shoulder, measuring strength by a dynamometer (IsoForceControl). Estimating Constant Shoulder Score.

次要结局

  • Quality of life(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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