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

Medical University of Gdansk100 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Breast Cancer

Interventions

Early drainage removalPROCEDURE

Drainage will be removed in postoperative day 1

Late drainage removalPROCEDURE

Drains will be kept until daily drainage is 30ml and then removed

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Gdansk, Department of Surgical Oncology

Gdansk, Pomeranian Voivodeship, Poland

RECRUITING

Outcomes

Primary Outcomes

Total lymph volume and time

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

Time frame: 3 months

Secondary Outcomes

Post operative pain assessment

Post operative pain assessment using VAS (Visual Analogue Scale) scale until 30 days after surgery

Time frame: 30 days

Central Contacts

Jacek Zielinski, MD, PhD

CONTACT

660 123 402 jaziel@gumed.edu.pl

Pawel Kabata, MD

CONTACT

509 707 959 pakabata@uck.gda.pl

Data from ClinicalTrials.gov

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