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

June 16, 2015 updated by: Joseph Vitello, MD, Jesse Brown VA Medical Center

A Prospective, Nonrandomized, Study Comparing the Use of Aspirin and Intraoperative Blood Loss and Postoperative Complications Following Open Inguinal Hernia Repair.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 81mg aspirin
This arm will include perioperative 81 mg of aspirin.
Drug: Aspirin
Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin
Other Names:
  • acetylsalicylic acid
Experimental: 325mg aspirin
Subjects will be taking 325mg of aspirin.
Drug: Aspirin
Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin
Other Names:
  • acetylsalicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative blood loss
Time Frame: intraoperative only
intraoperative blood loss will be accurately measured among the three arms of the study
intraoperative only

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: 30 days post operative
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
30 days post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jesse Brown VA Medical Center

Investigators

  • Principal Investigator: Joseph M Vitello, MD, Jesse Brown VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 9, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 16, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0976

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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