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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05178329
Other study ID # 93 /1801/2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2022
Est. completion date December 2024

Study information

Verified date December 2021
Source Turku University Hospital
Contact Anselm Tamminen, MD
Phone +35823138626
Email anselm.tamminen@tyks.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - patients with breast cancer diagnosis requiring mastectomy - patients being operated in day-care regime Exclusion Criteria: - patients not eligible for day-care mastectomy - patients undergoing axillary clearance operation

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Lifting exercise
Patients are instructed for a light lifting exercise after mastectomy.
Standard exercise
Standard exercise program after mastectomy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Anselm Tamminen

Outcome

Type Measure Description Time frame Safety issue
Primary Volume of seroma formation after mastectomy. 30 days
Secondary Number of wound problems requiring intervention. six months
Secondary Rate of lymphedema Difference in upper limb volume after the surgery one year
See also
  Status Clinical Trial Phase
Recruiting NCT03738527 - SEroma Reduction pOst MAstectomy "SEROMA Study" Phase 4