Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-09-30
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Intervention group
The patients undergoing intervention exercise.
Lifting exercise
Patients are instructed for a light lifting exercise after mastectomy.
Control Group
The patients undergoing the normal exercise program
Standard exercise
Standard exercise program after mastectomy
Interventions
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Lifting exercise
Patients are instructed for a light lifting exercise after mastectomy.
Standard exercise
Standard exercise program after mastectomy
Eligibility Criteria
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Inclusion Criteria
* patients being operated in day-care regime
Exclusion Criteria
* patients undergoing axillary clearance operation
FEMALE
No
Sponsors
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Anselm Tamminen
OTHER_GOV
Responsible Party
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Anselm Tamminen
Consultant General Surgeon
Principal Investigators
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Ilkka Koskivuo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
TYKS
Central Contacts
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Other Identifiers
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93 /1801/2021
Identifier Type: -
Identifier Source: org_study_id
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