Single Versus Double Drains After Mastectomy
Condition: Breast Cancer; Mastectomy
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

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.
    

Intervention name(s): Insertion of a single drain; Insertion of double drains; Ultrasonography after removal of the drains
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): A negative pressure drain will be inserted below the lower flap directing to the axilla.; Two drains will be inserted into the axilla and below the lower flap in the double drains group.; One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patient comfort; Drains; Breast cancer; Modified radical mastectomy; Seroma