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Single Versus Double Drains After Mastectomy

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ClinicalTrials.gov Identifier: NCT02202252
Recruitment Status : Completed
First Posted : July 28, 2014
Results First Posted : April 10, 2015
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Melih Akinci, Ankara Diskapi Training and Research Hospital

Brief Summary:

It is not known whether decreasing the number of drains used decreases patients' discomfort and duration of hospital stay without increasing seroma formation after mastectomies.

Hypothesis. Use of one drain increases patient comfort without increasing seroma formation after modified radical mastectomy (MRM) as compared to double drains.

Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and Research Hospital will be randomised into single versus double drains groups. A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group or two similar drains will be inserted into the axilla and below the lower flap in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of the patients duration of the hospital stay, duration of the drains in place, total drain output in the first three days after the operation and the need and frequency of aspirations due to seroma formation will be recorded. Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains, The duration of the longer staying drain in the double drain group will be recorded for the duration of the drain in place parameter.


Condition or disease Intervention/treatment Phase
Breast Cancer Mastectomy Procedure: Insertion of a single drain Procedure: Insertion of double drains Procedure: Ultrasonography after removal of the drains Not Applicable

Detailed Description:

Background: Seroma is one of the most common complications after mastectomies. Seroma formation results in delays in wound healing, incisional dehiscence, infections and long hospital stay. Although there are studies proving that drains do not prevent seroma formation, the use of drains for that purpose is still very common. Decreasing the number of drains used after mastectomies has been shown to decrease patients' discomfort and duration of hospital stay without increasing seroma formation.

Objective: To investigate the effects of single versus double drains on patient comfort and seroma formation after modified radical mastectomy (MRM) Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and Research Hospital will be randomised into single versus double drains groups. A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group or two similar drains will be inserted into the axilla and below the lower flap in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of the patients duration of the hospital stay, duration of the drains in place, total drain output in the first three days after the operation and the need and frequency of aspirations due to seroma formation will be recorded. Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains, The duration of the longer staying drain in the double drain group will be recorded for the duration of the drain in place parameter. Two groups will be compared with chi-square, student's t-test or Mann-Whitney U test. P<0.005 will be considered as significant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Single Versus Double Drains After Modified Radical Mastectomy
Study Start Date : July 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single drain

Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Procedure: Insertion of a single drain
A negative pressure drain will be inserted below the lower flap directing to the axilla.

Procedure: Ultrasonography after removal of the drains
One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Experimental: Double drain

Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Procedure: Insertion of double drains
Two drains will be inserted into the axilla and below the lower flap in the double drains group.

Procedure: Ultrasonography after removal of the drains
One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.




Primary Outcome Measures :
  1. Patient Comfort Scale [ Time Frame: Postoperative 5 days ]
    Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).


Secondary Outcome Measures :
  1. Seroma Formation [ Time Frame: Twenty-four hours after removal of the drains up to 4 weeks ]
    Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..


Other Outcome Measures:
  1. Length of Hospital Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer
  • Modified radical mastectomy

Exclusion Criteria:

  • Distant metastasis
  • Male breast cancer
  • Bleeding diathesis

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): NCT02202252


Locations
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Turkey
Diskapi Training and Research Hospital
Ankara, Turkey, 06110
Sponsors and Collaborators
Ankara Diskapi Training and Research Hospital
Publications:
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Responsible Party: Melih Akinci, Ankara Diskapi Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02202252    
Other Study ID Numbers: DGC-45
First Posted: July 28, 2014    Key Record Dates
Results First Posted: April 10, 2015
Last Update Posted: April 10, 2015
Last Verified: March 2015
Keywords provided by Melih Akinci, Ankara Diskapi Training and Research Hospital:
Patient comfort
Drains
Breast cancer
Modified radical mastectomy
Seroma
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases