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临床试验/NCT05178329
NCT05178329尚未招募不适用

Lifting Effect on Recovery After Mastectomy

Anselm Tamminen0 个研究点目标入组 50 人开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
Volume of seroma formation after mastectomy.

研究概览

简要总结

Breast cancer surgery has evolved towards ever more breast conserving direction. Even thought the surgical regime has become easier for the patient, many instructions given to the patient after the operation base on instructions, which have been used when the performed operations have been more burdensome.

Previously the patients have been instructed to lift only light objects after the operation, but according to the current knowledge, this instruction might be unnecessary.

The meaning of this study is to compare two patient groups to each other. The other group is instructed to avoid lifting, and the other group is given instructions to lift light weights several times daily.

In the study we compare will this have an effect on

  1. incidence of upper limb lymphedema
  2. seroma formation after surgery
  3. quality of patients life after the surgery

Inclusion criteria is patients underoing mastectomy but no axillary clearance on day-care basis. Patietns will be randomized in two groups, the other as an intervention group and other as an control group. The patients are asked to fill a questionnaire considering recovery from the operation and possible wound healing problems. The amount of seroma is recorded. The volume of upper limbs is measured before and after the surgery.

The study is started in January 2022 and finished in December 2024.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • patients with breast cancer diagnosis requiring mastectomy
  • patients being operated in day-care regime

排除标准

  • patients not eligible for day-care mastectomy
  • patients undergoing axillary clearance operation

结局指标

主要结局

Volume of seroma formation after mastectomy.

时间窗: 30 days

次要结局

  • Number of wound problems requiring intervention.(six months)
  • Rate of lymphedema(one year)

研究者

发起方
Anselm Tamminen
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Anselm Tamminen

Consultant General Surgeon

Turku University Hospital

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