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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hernia, Inguinal, Postoperative Complications, Postoperative Hemorrhage

Intervention / Treatment
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* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 81mg aspirin<br>This arm will include perioperative 81 mg of aspirin. | Drug: Aspirin<br>* Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin<br>* Other names: acetylsalicylic acid;|
| Experimental: 325mg aspirin<br>Subjects will be taking 325mg of aspirin. | Drug: Aspirin<br>* Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin<br>* Other names: acetylsalicylic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspirin, Postoperative hemorrhage, Inguinal hernia