Effect of Early vs Late Drainage Removal in Women After Radical Mastectomy With Axillary Clearance (CHLONKA)

Medical University of Gdansk

Status: Unknown

Conditions: Breast Cancer

Treatments: Procedure: Late drainage removal; Procedure: Early drainage removal

Study type: Interventional

Funder types: Other

Identifiers

NCT01221064

MUGSO-001

Details and patient eligibility

About

The aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea

Full description

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Early drainage removal

Other group

Description:

Patients randomised to early drainage removal arm will have the drain removed in postoperative day 1. Lymph will be punctured on a regular basis

Treatment:

Procedure: Early drainage removal

Late drainage removal

Other group

Description:

Patients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed

Treatment:

Procedure: Late drainage removal