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Prospective Randomised Clinical Trial Comparing the Effect of Early and Late Drainage Removal in Female Patients After Radical Mastectomy With Axillary Clearance


N/A
18 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Prospective Randomised Clinical Trial Comparing the Effect of Early and Late Drainage Removal in Female Patients After Radical Mastectomy With Axillary Clearance


Patients with early drainage removal will be compared with patients in whom drainage will be
kept until daily lymphorrhoea is 30ml


Inclusion Criteria:



- Stage IIA and IIB breast cancer treated with radical mastectomy

- Obtaining informed consent

- Total amount of lymph in postoperative day 1 <150ml

Exclusion Criteria:

- Stage I, III-IV breast cancer

- History of benign breast neoplasm or malignant disease of any origin

- Any breast surgery in the past

- Weight <50kg

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Total lymph volume and time

Outcome Description:

Assessment of total lymph volume and lymphorrhoea time up to 3 months after the surgery

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Janusz Jaƛkiewicz, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Medical University of Gdansk

Authority:

Poland: Ethics Committee

Study ID:

MUGSO-001

NCT ID:

NCT01221064

Start Date:

October 2010

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Axillary clearance
  • lymphorrhoea
  • Breast Neoplasms

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