Single Versus Double Drains After Mastectomy
Comparison of Single Versus Double Drains After Modified Radical Mastectomy
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey, 06110
- Diskapi Training and Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Breast cancer
- Modified radical mastectomy
Exclusion Criteria:
- Distant metastasis
- Male breast cancer
- Bleeding diathesis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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. |
A negative pressure drain will be inserted below the lower flap directing to the axilla.
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. |
One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Two drains will be inserted into the axilla and below the lower flap in the double drains group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
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Postoperative 5 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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..
|
Twenty-four hours after removal of the drains up to 4 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Length of Hospital Stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
Participants will be followed for the duration of hospital stay, an expected average of 5 days
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Collaborators and Investigators
Publications and helpful links
General Publications
- Akinci M, Cetin B, Aslan S, Kulacoglu H. Factors affecting seroma formation after mastectomy with full axillary dissection. Acta Chir Belg. 2009 Jul-Aug;109(4):481-3. doi: 10.1080/00015458.2009.11680464.
- Aitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. doi: 10.1016/s0039-6109(16)43192-0. No abstract available.
- Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60. doi: 10.1002/bjs.4435.
- Talbot ML, Magarey CJ. Reduced use of drains following axillary lymphadenectomy for breast cancer. ANZ J Surg. 2002 Jul;72(7):488-90. doi: 10.1046/j.1445-2197.2002.02456.x.
- Saratzis A, Soumian S, Willetts R, Rastall S, Stonelake PS. Use of multiple drains after mastectomy is associated with more patient discomfort and longer postoperative stay. Clin Breast Cancer. 2009 Nov;9(4):243-6. doi: 10.3816/CBC.2009.n.041.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DGC-45
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