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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Early drainage removal
Late drainage removal
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Axillary clearance, lymphorrhoea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Medical University of Gdansk, Department of Surgical OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Early drainage removal

Late drainage removal

Arm Description

Patients randomised to early drainage removal arm will have the drain removed in postoperative day 1. Lymph will be punctured on a regular basis

Patients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 6, 2010
Last Updated
January 30, 2012
Sponsor
Medical University of Gdansk
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1. Study Identification

Unique Protocol Identification Number
NCT01221064
Brief Title
Effect of Early vs Late Drainage Removal in Women After Radical Mastectomy With Axillary Clearance
Acronym
CHLONKA
Official Title
Prospective Randomised Clinical Trial Comparing the Effect of Early and Late Drainage Removal in Female Patients After Radical Mastectomy With Axillary Clearance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Gdansk

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Axillary clearance, lymphorrhoea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early drainage removal
Arm Type
Other
Arm Description
Patients randomised to early drainage removal arm will have the drain removed in postoperative day 1. Lymph will be punctured on a regular basis
Arm Title
Late drainage removal
Arm Type
Other
Arm Description
Patients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed
Intervention Type
Procedure
Intervention Name(s)
Early drainage removal
Intervention Description
Drainage will be removed in postoperative day 1
Intervention Type
Procedure
Intervention Name(s)
Late drainage removal
Intervention Description
Drains will be kept until daily drainage is 30ml and then removed
Primary Outcome Measure Information:
Title
Total lymph volume and time
Description
Assessment of total lymph volume and lymphorrhoea time up to 3 months after the surgery
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Post operative pain assessment
Description
Post operative pain assessment using VAS (Visual Analogue Scale) scale until 30 days after surgery
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacek Zielinski, MD, PhD
Phone
660 123 402
Ext
+48
Email
jaziel@gumed.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Pawel Kabata, MD
Phone
509 707 959
Ext
+48
Email
pakabata@uck.gda.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janusz Jaśkiewicz, MD, PhD
Organizational Affiliation
Medical University of Gdansk
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jacek Zielinski, MD, PhD
Organizational Affiliation
Medical University of Gdansk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Gdansk, Department of Surgical Oncology
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacek Zielinsk, MD, PhD
Phone
660 123 402
Ext
+48
Email
jaziel@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Pawel Kabata, MD
Phone
509 707 959
Ext
+48
Email
pakabata@uck.gda.pl
First Name & Middle Initial & Last Name & Degree
Jacek Zielinski, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pawel Kabata, MD
First Name & Middle Initial & Last Name & Degree
Maciej Bobowicz, MD
First Name & Middle Initial & Last Name & Degree
Piotr Rak, MD, PhD
First Name & Middle Initial & Last Name & Degree
Iwona Chruscicka, MD, PhD
First Name & Middle Initial & Last Name & Degree
Radoslaw Jaworski, MD, PhD

12. IPD Sharing Statement

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

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