Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2014-07-31
2015-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Insertion of a single drain
A negative pressure drain will be inserted below the lower flap directing to the axilla.
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.
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.
Insertion of double drains
Two 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.
Interventions
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Insertion of a single drain
A negative pressure drain will be inserted below the lower flap directing to the axilla.
Insertion of double drains
Two 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.
Eligibility Criteria
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Inclusion Criteria
* Modified radical mastectomy
Exclusion Criteria
* Male breast cancer
* Bleeding diathesis
18 Years
80 Years
FEMALE
No
Sponsors
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Ankara Diskapi Training and Research Hospital
OTHER
Responsible Party
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Melih Akinci
Melih Akinci
Locations
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Diskapi Training and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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DGC-45
Identifier Type: -
Identifier Source: org_study_id
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