Clinical trial NCT02084615: Prospective Study Investigating Aspirin and Intraoperative Blood Loss and Complications Following Inguinal Hernia Repair
Official title: A Prospective, Nonrandomized, Study Comparing the Use of Aspirin and Intraoperative Blood Loss and Postoperative Complications Following Open Inguinal Hernia Repair.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Postoperative Complications
Postoperative Hemorrhage
Keywords: Aspirin
Postoperative hemorrhage
Inguinal hernia
Lead sponsor: Jesse Brown VA Medical Center
Sponsor class: FED
First posted: 2014-03-12
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: intraoperative blood loss
timeFrame: intraoperative only
Secondary outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: 30 days post operative
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
Study officials:
affiliation: Jesse Brown VA Medical Center
name: Joseph M Vitello, MD
role: PRINCIPAL_INVESTIGATOR
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