Hernia, Inguinal, Postoperative Complications, Postoperative Hemorrhage
Conditions
Keywords
Aspirin, Postoperative hemorrhage, Inguinal hernia
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.
Interventions
DRUGAspirin
Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin
Sponsors
Jesse Brown VA Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | intraoperative only | intraoperative blood loss will be accurately measured among the three arms of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Serious and Non-Serious Adverse Events | 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 |
Countries
United States
Outcome results
None listed