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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Medical University of Gdansk.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jacek Zielinski, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01221064
First received: October 6, 2010
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Breast Cancer
Procedure: Early drainage removal
Procedure: Late drainage removal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prospective Randomised Clinical Trial Comparing the Effect of Early and Late Drainage Removal in Female Patients After Radical Mastectomy With Axillary Clearance

Resource links provided by NLM:


Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • Total lymph volume and time [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assessment of total lymph volume and lymphorrhoea time up to 3 months after the surgery


Secondary Outcome Measures:
  • Post operative pain assessment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Post operative pain assessment using VAS (Visual Analogue Scale) scale until 30 days after surgery


Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: Early drainage removal
Drainage will be removed in postoperative day 1
Late drainage removal
Patients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed
Procedure: Late drainage removal
Drains will be kept until daily drainage is 30ml and then removed

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221064

Contacts
Contact: Jacek Zielinski, MD, PhD 660 123 402 ext +48 jaziel@gumed.edu.pl
Contact: Pawel Kabata, MD 509 707 959 ext +48 pakabata@uck.gda.pl

Locations
Poland
Medical University of Gdansk, Department of Surgical Oncology Recruiting
Gdansk, Pomorskie, Poland, 80-952
Contact: Jacek Zielinsk, MD, PhD    660 123 402 ext +48    jaziel@gumed.edu.pl   
Contact: Pawel Kabata, MD    509 707 959 ext +48    pakabata@uck.gda.pl   
Principal Investigator: Jacek Zielinski, MD, PhD         
Sub-Investigator: Pawel Kabata, MD         
Sub-Investigator: Maciej Bobowicz, MD         
Sub-Investigator: Piotr Rak, MD, PhD         
Sub-Investigator: Iwona Chruscicka, MD, PhD         
Sub-Investigator: Radoslaw Jaworski, MD, PhD         
Sponsors and Collaborators
Medical University of Gdansk
Investigators
Study Director: Janusz Jaśkiewicz, MD, PhD Medical University of Gdansk
Principal Investigator: Jacek Zielinski, MD, PhD Medical University of Gdansk
  More Information

No publications provided

Responsible Party: Jacek Zielinski, Assistant Profesor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01221064     History of Changes
Other Study ID Numbers: MUGSO-001
Study First Received: October 6, 2010
Last Updated: January 30, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Gdansk:
Breast cancer
Axillary clearance
lymphorrhoea

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2014