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

Not Applicable

• Conditions: Hernia, Inguinal; Postoperative Complications; Postoperative Hemorrhage
• Interventions: Drug: Aspirin

• Registration Number: NCT02084615
• Lead Sponsor: Jesse Brown VA Medical Center

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.

Study Timeline

• Study First Submitted: 2014-03-09
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-12
• Study Start: 2014-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-18
• Primary Completion: 2016-08
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
81mg aspirin	Aspirin	This arm will include perioperative 81 mg of aspirin.
325mg aspirin	Aspirin	Subjects will be taking 325mg of aspirin.

Primary Outcome Measures

Name	Time	Method
intraoperative blood loss	intraoperative only	intraoperative blood loss will be accurately measured among the three arms of the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jesse Brown VA Medical Center; 🇺🇸 Chicago, Illinois, United States