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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01221064

Acronym

CHLONKA

Enrollment

100

Registered

2010-10-14

Start date

2010-10-31

Completion date

2014-05-31

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, Axillary clearance, lymphorrhoea

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

Interventions

PROCEDUREEarly drainage removal

Drainage will be removed in postoperative day 1

PROCEDURELate drainage removal

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Total lymph volume and time	3 months	Assessment of total lymph volume and lymphorrhoea time up to 3 months after the surgery

Secondary

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

Countries

Poland

Contacts

Primary ContactJacek Zielinski, MD, PhD

jaziel@gumed.edu.pl660 123 402

Backup ContactPawel Kabata, MD

pakabata@uck.gda.pl509 707 959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026