N/A
N=60
Single Versus Double Drains After Mastectomy
Breast Cancer · Mastectomy
Bottom Line
View on ClinicalTrials.gov: NCT02202252 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Patient Comfort Scale — 3; 3 units on a scale — p=0.490
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Insertion of a single drain (Procedure); Insertion of double drains (Procedure); Ultrasonography after removal of the drains (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ankara Diskapi Training and Research Hospital
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Comfort Scale |
3; 3 | 0.490 |
| SECONDARY Seroma Formation |
18; 10 | 0.035 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Breast cancer
- Modified radical mastectomy
Exclusion Criteria
- Distant metastasis
- Male breast cancer
- Bleeding diathesis
Data sourced from ClinicalTrials.gov (NCT02202252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.