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

January 30, 2012 updated by: Jacek Zielinski, Medical University of Gdansk

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-952
        • Recruiting
        • Medical University of Gdansk, Department of Surgical Oncology
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 13, 2010

First Posted (Estimate)

October 14, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUGSO-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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