Single Versus Double Drains After Mastectomy

• ClinicalTrials.gov Identifier: NCT02202252
• Recruitment Status: Completed
• First Posted: July 28, 2014
• Results First Posted: April 10, 2015
• Last Update Posted: April 10, 2015
• Sponsor: Ankara Diskapi Training and Research Hospital
• Information provided by (Responsible Party): Melih Akinci, Ankara Diskapi Training and Research Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Mastectomy	Procedure: Insertion of a single drain; Procedure: Insertion of double drains; Procedure: Ultrasonography after removal of the drains	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Single Versus Double Drains After Modified Radical Mastectomy
• Study Start Date: July 2014
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Procedure: Insertion of a single drain; A negative pressure drain will be inserted below the lower flap directing to the axilla.; Procedure: 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.
Experimental: 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.	Procedure: Insertion of double drains; Two drains will be inserted into the axilla and below the lower flap in the double drains group.; Procedure: 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

1. Length of Hospital Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Breast cancer
• Modified radical mastectomy

Exclusion Criteria:

• Distant metastasis
• Male breast cancer
• Bleeding diathesis

Contacts and Locations

Locations

Turkey

Diskapi Training and Research Hospital

Ankara, Turkey, 06110

Sponsors and Collaborators

Ankara Diskapi Training and Research Hospital

More Information

Publications:

Akinci M, Cetin B, Aslan S, Kulacoglu H. Factors affecting seroma formation after mastectomy with full axillary dissection. Acta Chir Belg. 2009 Jul-Aug;109(4):481-3.

Aitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. Review.

Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60.

Talbot ML, Magarey CJ. Reduced use of drains following axillary lymphadenectomy for breast cancer. ANZ J Surg. 2002 Jul;72(7):488-90.

Saratzis A, Soumian S, Willetts R, Rastall S, Stonelake PS. Use of multiple drains after mastectomy is associated with more patient discomfort and longer postoperative stay. Clin Breast Cancer. 2009 Nov;9(4):243-6. doi: 10.3816/CBC.2009.n.041.

• Responsible Party: Melih Akinci, Ankara Diskapi Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT02202252
• Other Study ID Numbers: DGC-45
• First Posted: July 28, 2014
• Results First Posted: April 10, 2015
• Last Update Posted: April 10, 2015
• Last Verified: March 2015

Keywords provided by Melih Akinci, Ankara Diskapi Training and Research Hospital:

Patient comfort; Drains; Breast cancer; Modified radical mastectomy; Seroma

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases