A Prospective, Nonrandomized, Study Comparing the Use of Aspirin and Intraoperative Blood Loss and Postoperative Complications Following Open Inguinal Hernia Repair.
Overview
- Phase
- Not Applicable
- Intervention
- Aspirin
- Conditions
- Hernia, Inguinal
- Sponsor
- Jesse Brown VA Medical Center
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- intraoperative blood loss
- Last Updated
- 10 years ago
Overview
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.
Investigators
Joseph Vitello, MD
Interim Chief of Surgical Services
Jesse Brown VA Medical Center
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
- •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
Arms & Interventions
81mg aspirin
This arm will include perioperative 81 mg of aspirin.
Intervention: Aspirin
325mg aspirin
Subjects will be taking 325mg of aspirin.
Intervention: Aspirin
Outcomes
Primary Outcomes
intraoperative blood loss
Time Frame: intraoperative only
intraoperative blood loss will be accurately measured among the three arms of the study
Secondary Outcomes
- Number of Participants with Serious and Non-Serious Adverse Events(30 days post operative)