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NCT Number: NCT02202252

Single Versus Double Drains After Mastectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Diskapi Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Breast cancer
  • Modified radical mastectomy

Exclusion criteria

  • Distant metastasis
  • Male breast cancer
  • Bleeding diathesis

Treatment and study plan

Insertion of a single drain

Procedure

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

Insertion of double drains

Procedure

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

Ultrasonography after removal of the drains

Procedure

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

Primary outcomes

  1. Patient Comfort Scale

    Time frame: 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 outcomes

  1. Seroma Formation

    Time frame: 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 outcomes

  1. Length of Hospital Stay

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

Sponsors and collaborators

Lead sponsor

Ankara Diskapi Training and Research Hospital

Other

Registry information

Official study title

Comparison of Single Versus Double Drains After Modified Radical Mastectomy

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 28, 2014
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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