An interventional study of Insertion of a single drain and Insertion of double drains in Breast Cancer and Mastectomy, sponsored by Ankara Diskapi Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-04-10.
Sponsored by Ankara Diskapi Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Ankara Diskapi Training and Research Hospital is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 · Procedure: Ultrasonography after removal of the drains
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 · Procedure: Ultrasonography after removal of the drains
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.
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
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
Length of Hospital Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
The recruitment period: July 2014-february 2015 Location: Dıskapi Research and training Hospital General Surgery Clinic
| Milestone | Single Drain | Double Drain |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
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).
| units on a scale | Single Drain | Double Drain |
|---|---|---|
| Patient Comfort Scale | 3 (1 to 8) | 3 (1 to 9) |
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..
| participants | Single Drain | Double Drain |
|---|---|---|
| Seroma Formation | 18 | 10 |
| days | Single Drain | Double Drain |
|---|---|---|
| Length of Hospital Stay | 3 (2 to 7) | 3 (2 to 17) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Drain | — | 0/30 (0%) | 0/30 (0%) |
| Double Drain | — | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Single Drain | Double Drain | Total |
|---|---|---|---|
| Mean | 54.1 ± 11.6 | 53.9 ± 11.5 | 54 ± 11.5 |
| Sex: Female, Male(Participants) | Single Drain | Double Drain | Total |
|---|---|---|---|
| Female | 30 | 30 | 60 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Ankara Diskapi Training and Research Hospital