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临床试验/NCT03796845
NCT03796845已完成不适用

Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery

Instituto Nacional de Cancer, Brazil2 个研究点 分布在 1 个国家目标入组 465 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
465
试验地点
2
主要终点
Presence or absence of wound complications.

研究概览

简要总结

Randomized clinical trial that will include women aged 18 or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA). Patients will be allocated into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points). Sociodemographic and clinical data will be collected through interviews, questionnaires and electronic and physical records. The outcomes will be incidence of operative wound complications, like edema, joint restraint, winged scapula, pain, axillary web syndrome through the physical examination, performed by the nursing and physiotherapy team throughout the intervention period, ending in the 30-day post-operatory.

详细描述

Breast cancer treatment has been accompanying advances in technology, surgeries are more conservative, however postoperative complications are still observed. At early postoperative period, the most common operative wound complications are seroma, infection and necrosis. Shoulder dysfunctions are a frequent complication and difficult women to return to their activities. There is no consensus regarding the onset and type of exercise in postoperative period. Thus, the objective of this study is to compare the active no-limited mobilization with limited mobilization in the immediate post operatory at the incidence of wound complications in women submitted to surgery for the treatment of breast cancer.

It's a randomized clinical trial that will include women aged 18 years or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA) located in Rio de Janeiro. All patients admitted for surgical treatment at the institution and during the study period will be evaluated for eligibility criteria. Those considered eligible for the study will be clarified regarding the objectives, treatment groups, adverse effects and non-compulsory participation of the study. Upon acceptance to participate, they will be allocated to the respective intervention groups. Group 1 - upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder; Group 2 - upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 and over;
  • Indication of curative surgical treatment for breast cancer axillary approach at Hospital do Câncer III / INCA.

排除标准

  • Bilateral breast cancer;
  • Surgical treatment and / or previous radiotherapy for breast cancer;
  • Reconstruction surgery;
  • Functional alteration in upper limbs prior to diagnosis of breast cancer;
  • Illiterate women who are not able to read and complete the protocol of adhesion;
  • Women who are not able to answer questions clearly;
  • Age over 80.

结局指标

主要结局

Presence or absence of wound complications.

时间窗: Thirty days of follow-up

Occurrence of wound complications (necrosis, dehiscence, seroma, infection or hematoma) will be obtained by the physical examination, performed routinely by the nursing and physiotherapy during the first month after the surgical procedure.

次要结局

  • Measurement of shoulder's range of motion(Thirty days of follow-up)
  • Measurement of upper limb functionality(Thirty days of follow-up)

研究者

发起方
Instituto Nacional de Cancer, Brazil
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anke Bergmann

Principal Investigator

Instituto Nacional de Cancer, Brazil

研究点 (2)

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