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

Not Applicable

• Conditions: Breast Cancer
• Interventions: Procedure: Early drainage removal; Procedure: Late drainage removal

• Registration Number: NCT01221064
• Lead Sponsor: Medical University of Gdansk

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-30
• Last Update Posted: 2012-01-31
• Primary Completion: 2013-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early drainage removal	Early drainage removal	Patients randomised to early drainage removal arm will have the drain removed in postoperative day 1. Lymph will be punctured on a regular basis
Late drainage removal	Late drainage removal	Patients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed

Primary Outcome Measures

Name	Time	Method
Total lymph volume and time	3 months	Assessment of total lymph volume and lymphorrhoea time up to 3 months after the surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Gdansk, Department of Surgical Oncology; 🇵🇱 Gdansk, Pomorskie, Poland