Prospective Study Comparing Aspirin Versus Placebo and Blood Loss in Inguinal Hernia Repair
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital, Hospital, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | May 2014 |
| End Date: | June 2016 |
| Contact: | Joseph M Vitello, MD |
| Email: | joseph.vitello@va.gov |
| Phone: | 630-234-8214 |
A Prospective, Randomized, Double-blinded Study Comparing the Use of Aspirin Versus Placebo and Intraoperative Blood Loss and Postoperative Complications Following Open Inguinal Hernia Repair.
The purpose of this study is to determine whether aspirin administered 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.
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.
This is a prospective, randomized, double-blinded study which compares the use of 81mg of
aspirin, 325mg of aspirin and placebo in adult men undergoing an open tension free mesh
inguinal hernia repair. Subjects will be randomized to one of the three groups
preoperatively. Study medication will be administered for 7 days preoperatively and 7 days
postoperatively. 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.
aspirin, 325mg of aspirin and placebo in adult men undergoing an open tension free mesh
inguinal hernia repair. Subjects will be randomized to one of the three groups
preoperatively. Study medication will be administered for 7 days preoperatively and 7 days
postoperatively. 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.
Inclusion Criteria:
- adult male veterans ages 18-99
- inguinal hernia
Exclusion Criteria:
- recurrent hernia
- "giant" hernia
- women
- known allergy or adverse reaction to aspirin
- known allergy to non steroidal anti-inflammatory drugs
- active peptic ulcer disease
- heavy alcohol use (greater than 5 drinks/day)
- International Normalized Ratio > 1.7
- Hemophilia or other know congenital bleeding disorder
- Subject currently taking aspirin with history of prior cerebral vascular accident
- Subject with known cardiac, coronary, carotid or other vascular stents on aspirin
therapy
- Subjects currently on aspirin therapy under the advise of a physician where
withdrawal of aspirin therapy could be hazardous
- severe renal insufficiency (GFR < 10 mL/min)
- Cirrhosis of hepatitis with coagulopathy
- Thrombocytopenia with platelet counts < 100,000
- Subjects currently on Coumadin or other platelet inhibitors
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