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Prospective Study Investigating Aspirin and Intraoperative Blood Loss and Complications Following Inguinal Hernia Repair

Primary Purpose

Hernia, Inguinal, Postoperative Complications, Postoperative Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Sponsored by
Jesse Brown VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring Aspirin, Postoperative hemorrhage, Inguinal hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • adult male veterans ages 18-99
  • inguinal hernia
  • subjects currently taking 81mg, 325mg or no aspirin

Exclusion Criteria:

  • recurrent hernia
  • "giant" hernia
  • women
  • International Normalized Ratio > 1.7
  • Hemophilia or other know congenital bleeding disorder
  • Cirrhosis of hepatitis with coagulopathy
  • Thrombocytopenia with platelet counts < 100,000
  • Subjects currently on Coumadin or other platelet inhibitors

Sites / Locations

  • Jesse Brown VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

81mg aspirin

325mg aspirin

Arm Description

This arm will include perioperative 81 mg of aspirin.

Subjects will be taking 325mg of aspirin.

Outcomes

Primary Outcome Measures

intraoperative blood loss
intraoperative blood loss will be accurately measured among the three arms of the study

Secondary Outcome Measures

Number of Participants with Serious and Non-Serious Adverse Events
Subjects will be followed for 30 days post-operatively for bleeding complications such as early return to the operating room to control bleeding, wound hematoma, scrotal hematoma, wound infection, early hernia recurrence, or excessive wound ecchymosis

Full Information

First Posted
March 9, 2014
Last Updated
June 16, 2015
Sponsor
Jesse Brown VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02084615
Brief Title
Prospective Study Investigating Aspirin and Intraoperative Blood Loss and Complications Following Inguinal Hernia Repair
Official Title
A Prospective, Nonrandomized, Study Comparing the Use of Aspirin and Intraoperative Blood Loss and Postoperative Complications Following Open Inguinal Hernia Repair.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jesse Brown VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether aspirin taken in the perioperative period will increase the blood loss associated with open inguinal hernia repairs. A secondary purpose of this study is to determine if the aspirin administered in the perioperative period increases the risk of complications associated with open inguinal hernia repairs.
Detailed Description
This is a prospective, non-randomized, study which compares the use of 81mg of aspirin, 325mg of aspirin or no aspirin in adult men undergoing an open tension free mesh inguinal hernia repair. Subjects currently taking 81mg or 325mg of aspirin will undergo inguinal hernia repair without having their medications stopped. Patient not currently taking aspirin will act as controls. Intraoperative blood loss will be measured utilizing a gravimetric method by weighing surgical sponges before and after use. Subjects will be followed for thirty days postoperatively and be evaluated for bleeding complications. The specific complications include wound or scrotal hematomas, return to the operating room within 72 hour for bleeding, wound infection, early recurrent hernia, excessive wound ecchymosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal, Postoperative Complications, Postoperative Hemorrhage
Keywords
Aspirin, Postoperative hemorrhage, Inguinal hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
81mg aspirin
Arm Type
Experimental
Arm Description
This arm will include perioperative 81 mg of aspirin.
Arm Title
325mg aspirin
Arm Type
Experimental
Arm Description
Subjects will be taking 325mg of aspirin.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
acetylsalicylic acid
Intervention Description
Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin
Primary Outcome Measure Information:
Title
intraoperative blood loss
Description
intraoperative blood loss will be accurately measured among the three arms of the study
Time Frame
intraoperative only
Secondary Outcome Measure Information:
Title
Number of Participants with Serious and Non-Serious Adverse Events
Description
Subjects will be followed for 30 days post-operatively for bleeding complications such as early return to the operating room to control bleeding, wound hematoma, scrotal hematoma, wound infection, early hernia recurrence, or excessive wound ecchymosis
Time Frame
30 days post operative

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult male veterans ages 18-99 inguinal hernia subjects currently taking 81mg, 325mg or no aspirin Exclusion Criteria: recurrent hernia "giant" hernia women International Normalized Ratio > 1.7 Hemophilia or other know congenital bleeding disorder Cirrhosis of hepatitis with coagulopathy Thrombocytopenia with platelet counts < 100,000 Subjects currently on Coumadin or other platelet inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M Vitello, MD
Organizational Affiliation
Jesse Brown VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jesse Brown VA Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
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22048442
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PubMed Identifier
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Citation
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Citation
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Prospective Study Investigating Aspirin and Intraoperative Blood Loss and Complications Following Inguinal Hernia Repair

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