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

N/AUnknownNCT02084615

Jesse Brown VA Medical Center300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Hernia, Inguinal Postoperative Complications Postoperative Hemorrhage

Interventions

AspirinDRUG

Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Jesse Brown VA Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

intraoperative blood loss

intraoperative blood loss will be accurately measured among the three arms of the study

Time frame: intraoperative only

Secondary Outcomes

Number of Participants with Serious and Non-Serious Adverse Events

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

Time frame: 30 days post operative

Data from ClinicalTrials.gov

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