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Single Versus Double Drains After Mastectomy

Comparison of Single Versus Double Drains After Modified Radical Mastectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02202252
Enrollment
60
Registered
2014-07-28
Start date
2014-07-31
Completion date
2015-02-28
Last updated
2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Mastectomy

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

PROCEDUREInsertion of a single drain

A negative pressure drain will be inserted below the lower flap directing to the axilla.

PROCEDUREInsertion of double drains

Two drains will be inserted into the axilla and below the lower flap in the double drains group.

PROCEDUREUltrasonography 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.

Sponsors

Ankara Diskapi Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Breast cancer * Modified radical mastectomy

Exclusion criteria

* Distant metastasis * Male breast cancer * Bleeding diathesis

Design outcomes

Primary

MeasureTime frameDescription
Patient Comfort ScalePostoperative 5 daysPatient 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

MeasureTime frameDescription
Seroma FormationTwenty-four hours after removal of the drains up to 4 weeksSeroma 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

MeasureTime frame
Length of Hospital StayParticipants 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

ArmCount
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
Total60

Baseline characteristics

CharacteristicSingle DrainDouble DrainTotal
Age, Continuous54.1 years
STANDARD_DEVIATION 11.6
53.9 years
STANDARD_DEVIATION 11.5
54 years
STANDARD_DEVIATION 11.5
Sex: Female, Male
Female
30 Participants30 Participants60 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 30

Outcome results

Primary

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

ArmMeasureValue (MEDIAN)
Single DrainPatient Comfort Scale3 units on a scale
Double DrainPatient Comfort Scale3 units on a scale
p-value: 0.49Wilcoxon (Mann-Whitney)
Secondary

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

ArmMeasureValue (NUMBER)
Single DrainSeroma Formation18 participants
Double DrainSeroma Formation10 participants
p-value: 0.035Chi-squared
Other Pre-specified

Length of Hospital Stay

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days

ArmMeasureValue (MEDIAN)
Single DrainLength of Hospital Stay3 days
Double DrainLength of Hospital Stay3 days
p-value: 0.819Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026