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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Jacek Zielinski, Medical University of Gdansk.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01221064
First Posted: October 14, 2010
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jacek Zielinski, Medical University of Gdansk
  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
Intervention Model: Parallel Assignment
Masking: None (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 Jacek Zielinski, Medical University of Gdansk:

Primary Outcome Measures:
  • Total lymph volume and time [ Time Frame: 3 months ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jacek Zielinski, Assistant Profesor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01221064     History of Changes
Other Study ID Numbers: MUGSO-001
First Submitted: October 6, 2010
First Posted: October 14, 2010
Last Update Posted: January 31, 2012
Last Verified: January 2012

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