Breast Cancer, Mastectomy
Conditions
Keywords
Patient comfort, Drains, Breast cancer, Modified radical mastectomy, Seroma
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.
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* Breast cancer * Modified radical mastectomy
Exclusion criteria
* Distant metastasis * Male breast cancer * Bleeding diathesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Seroma Formation | 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
| Measure | Time frame |
|---|---|
| Length of Hospital Stay | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
The recruitment period: July 2014-february 2015 Location: Dıskapi Research and training Hospital General Surgery Clinic
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Single Drain | Double Drain | Total |
|---|---|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 11.6 | 53.9 years STANDARD_DEVIATION 11.5 | 54 years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Patient Comfort Scale
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).
Time frame: Postoperative 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Drain | Patient Comfort Scale | 3 units on a scale |
| Double Drain | Patient Comfort Scale | 3 units on a scale |
Seroma Formation
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..
Time frame: Twenty-four hours after removal of the drains up to 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Drain | Seroma Formation | 18 participants |
| Double Drain | Seroma Formation | 10 participants |
Length of Hospital Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Drain | Length of Hospital Stay | 3 days |
| Double Drain | Length of Hospital Stay | 3 days |