Single vs. Double Drain in Modified Radical Mastectomy

NCT ID: NCT02411617

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Modified Radical mastectomy is commonly performed procedure for carcinoma breast. After surgery two drains are placed, one in axilla and one beneath the flap. The use of two drains is associated with significant post operative discomfort and pain. On the other hand two drains have not been proven to decrease post operative seroma formation.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single drain in modified radical mastectomy

Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain

Group Type ACTIVE_COMPARATOR

Drain

Intervention Type DEVICE

Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain

Double drain in modified radical mastectomy

Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain

Group Type ACTIVE_COMPARATOR

Drain

Intervention Type DEVICE

Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain

Interventions

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Drain

Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All female patients underwent MRM for biopsy proven carcinoma breast

Exclusion Criteria

* Immediate reconstruction
* Patient refusal to participate in study
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Memon Medical Institute

OTHER

Sponsor Role lead

Responsible Party

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salma khan

Consultant General Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 38026913 (View on PubMed)

Other Identifiers

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ERC:02

Identifier Type: -

Identifier Source: org_study_id

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