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

Jesse Brown VA Medical Center

Status: Unknown

Conditions: Postoperative Complications; Postoperative Hemorrhage; Hernia, Inguinal

Treatments: Drug: Aspirin

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02084615

2013-0976

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

81mg aspirin

Experimental group

Description:

This arm will include perioperative 81 mg of aspirin.

Treatment:

Drug: Aspirin

325mg aspirin

Experimental group

Description:

Subjects will be taking 325mg of aspirin.

Treatment:

Drug: Aspirin