Single vs. Double Drain in Modified Radical Mastectomy
1 other identifier
interventional
176
0 countries
N/A
Brief Summary
Seroma is a common complication following modified radical mastectomy(MRM). Closed drainage is used routinely to reduce incidence of seroma. Usually two drains are used in patients who underwent MRM to reduce post operative seroma. It is often associated with significant patient discomfort and prolonged fluid drainage. The aim of this study is to evaluate effect of number of drains on seroma formation rate, postoperative pain and hospital stay during the immediate postoperative period after mastectomy for breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jan 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 27, 2015
CompletedFirst Posted
Study publicly available on registry
April 8, 2015
CompletedApril 8, 2015
April 1, 2015
1.8 years
February 27, 2015
April 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
seroma formation
fluid collection beneath the flap sufficient to cause patient discomfort and pain
30 days post surgery
Secondary Outcomes (5)
Duration of hospital stay,,
30 days after surgery
wound infection
30 days after surgery
postoperative pain
30 days after surgery
hematoma
30 days after surgery
flap necrosis
30 days after surgery
Study Arms (2)
Single drain in modified radical mastectomy
ACTIVE COMPARATORPost modified radical mastectomy with either one or two drains Intervention is use of single or double drain
Double drain in modified radical mastectomy
ACTIVE COMPARATORPost modified radical mastectomy with either one or two drains Intervention is use of single or double drain
Interventions
Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain
Eligibility Criteria
You may qualify if:
- All female patients underwent MRM for biopsy proven carcinoma breast
You may not qualify if:
- Immediate reconstruction
- Patient refusal to participate in study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Khan S, Khan M, Wasim A. Single vs. double drain in modified radical mastectomy: A randomized controlled trial. Turk J Surg. 2023 Jun 19;39(2):145-152. doi: 10.47717/turkjsurg.2023.5666. eCollection 2023 Jun.
PMID: 38026913DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant General Surgeon
Study Record Dates
First Submitted
February 27, 2015
First Posted
April 8, 2015
Study Start
January 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
April 8, 2015
Record last verified: 2015-04