NCT02202252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 10, 2015

Completed
Last Updated

April 10, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

July 23, 2014

Results QC Date

March 9, 2015

Last Update Submit

March 25, 2015

Conditions

Breast CancerMastectomy

Keywords

Patient comfortDrainsBreast cancerModified radical mastectomySeroma

Outcome Measures

Primary Outcomes (1)

  • 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).

    Postoperative 5 days

Secondary Outcomes (1)

  • Seroma Formation

    Twenty-four hours after removal of the drains up to 4 weeks

Other Outcomes (1)

  • Length of Hospital Stay

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

Study Arms (2)

Single drain

EXPERIMENTAL

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 drainProcedure: Ultrasonography after removal of the drains

Double drain

EXPERIMENTAL

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 drainsProcedure: Ultrasonography after removal of the drains

Interventions

Insertion of a single drainPROCEDURE

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

Single drain
Insertion of double drainsPROCEDURE

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

Double drain
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.

Double drainSingle drain

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer
  • Modified radical mastectomy

You may not qualify if:

  • Distant metastasis
  • Male breast cancer
  • Bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (5)

  • 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. doi: 10.1080/00015458.2009.11680464.

    PMID: 19803259BACKGROUND

  • Aitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. doi: 10.1016/s0039-6109(16)43192-0. No abstract available.

    PMID: 6359504BACKGROUND

  • 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. doi: 10.1002/bjs.4435.

    PMID: 14716794BACKGROUND

  • Talbot ML, Magarey CJ. Reduced use of drains following axillary lymphadenectomy for breast cancer. ANZ J Surg. 2002 Jul;72(7):488-90. doi: 10.1046/j.1445-2197.2002.02456.x.

    PMID: 12123509BACKGROUND

  • 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.

    PMID: 19933080BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsSeroma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Melih Akinci, MD, Associate Prof
Organization
Diskapi Training and Research Hospital
melihakinci@yahoo.com
90 312 5962080

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Melih Akinci

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 28, 2014

Study Start

July 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 10, 2015

Results First Posted

April 10, 2015

Record last verified: 2015-03

Locations

TU(1)