CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Insertion of a single drain +2 moreprocedure
Likely dose
Not stated in record
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Search/NCT02202252
NCT02202252N/ACompleted

Comparison of Single Versus Double Drains After Modified Radical Mastectomy

Ankara Diskapi Training and Research Hospital·interventional·Posted Jul 28, 2014·Updated Apr 10, 2015

In Brief

A clinical study evaluating Insertion of a single drain, Insertion of double drains, and 1 other intervention for Breast Cancer and Mastectomy. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 28, 2014
Enrollment StartJul 1, 2014
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.9 years ago

Interventions

Insertion of a single drainprocedure

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

Insertion of double drainsprocedure

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

Ultrasonography after removal of the drainsprocedure

One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.