NCT03280043

Brief Summary

The investigators hope to answer the question, "does ketorolac increase the risk of hematoma after reduction mammoplasty?" using a case-control study. All patients who developed a hematoma post reduction mammoplasty (cases) at our institution, and match these with women who had an uncomplicated reduction mammoplasty (controls), and then compare frequency of ketorolac exposure between these two groups as the primary outcome. If ketorolac increases the risk of hematoma, one should expect cases to have been exposed to ketorolac more frequently than controls. Based on previously existing literature, the investigators hypothesize that cases and controls will not differ in their ketorolac exposure, that is, ketorolac does not increase the risk of hematoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

2 active sites

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

September 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

1.7 years

First QC Date

May 24, 2017

Last Update Submit

September 8, 2017

Conditions

Breast ReductionReduction MammoplastyHematomaHemorrhage

Keywords

Breast reductionReduction mammoplastyHematomaHemorrhageKetorolacToradol

Outcome Measures

Primary Outcomes (1)

  • Ketorolac exposure.

    Whether or not cases and controls were exposed to ketorolac on the day of surgery will be determined and compiled as a categorical variable (yes/no).

    Sept 2015 - Aug 2017.

Secondary Outcomes (13)

  • Year of reduction mammoplasty.

    Sept 2015 - Aug 2017.

  • Age of patients in each group will be calculated.

    Sept 2015 - Aug 2017.

  • Body mass index compared between cases and controls.

    Sept 2015 - Aug 2017.

  • Volume of breast tissue resected during surgery (in grams) for each patient.

    Sept 2015 - Aug 2017.

  • Pre-operative platelet count.

    Sept 2015 - Aug 2017.

  • +8 more secondary outcomes

Study Arms (2)

Cases

Women who underwent reduction mammoplasty and then developed a hematoma which required return to the operating room for evacuation.

Procedure: Hematoma

Controls

Women who had uncomplicated reduction mammoplasty.

Interventions

HematomaPROCEDURE

Hematoma requiring return to operating room.

Cases

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical coders will identify all possible cases of hematoma by searching the key words "hemorrhage," "hematoma," and "plastic surgery". Hematomas post reduction mammoplasty will be manually retrieved and reviewed. Control patients will be randomly pulled from the database of uncomplicated reduction mammoplasties.

You may qualify if:

  • Cases:
  • \- Patients who developed hematoma post-reduction mammoplasty requiring repeat surgery
  • Controls:
  • \- Uncomplicated bilateral reduction mammoplasty

You may not qualify if:

  • Hematoma patients treated with observation or needle aspiration
  • Concomitant surgeries in addition to the reduction mammoplasty
  • Allergy/sensitivity to non-steroidal anti-inflammatory drugs
  • Unilateral reduction mammoplasty
  • Male reduction mammoplasty
  • Documented bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8N3Z5, Canada

Location

Related Publications (1)

  • Cawthorn TR, Phelan R, Davidson JS, Turner KE. Retrospective analysis of perioperative ketorolac and postoperative bleeding in reduction mammoplasty. Can J Anaesth. 2012 May;59(5):466-72. doi: 10.1007/s12630-012-9682-z. Epub 2012 Mar 21.

    PMID: 22434401BACKGROUND

MeSH Terms

Conditions

HematomaHemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Achilleas Thoma, MD, MSc, BSc

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2017

First Posted

September 12, 2017

Study Start

September 1, 2015

Primary Completion

May 20, 2017

Study Completion

August 20, 2017

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)