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

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.

Full Title of Study: “A Prospective, Nonrandomized, Study Comparing the Use of Aspirin and Intraoperative Blood Loss and Postoperative Complications Following Open Inguinal Hernia Repair.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2016

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

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

Arms, Groups and Cohorts

  • Experimental: 81mg aspirin
    • This arm will include perioperative 81 mg of aspirin.
  • Experimental: 325mg aspirin
    • Subjects will be taking 325mg of aspirin.

Clinical Trial Outcome Measures

Primary Measures

  • intraoperative blood loss
    • Time Frame: intraoperative only
    • intraoperative blood loss will be accurately measured among the three arms of the study

Secondary Measures

  • Number of Participants with Serious and Non-Serious Adverse Events
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jesse Brown VA Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joseph Vitello, MD, Interim Chief of Surgical Services – Jesse Brown VA Medical Center
  • Overall Official(s)
    • Joseph M Vitello, MD, Principal Investigator, Jesse Brown VA Medical Center

References

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Leyh-Bannurah SR, Hansen J, Isbarn H, Steuber T, Tennstedt P, Michl U, Schlomm T, Haese A, Heinzer H, Huland H, Graefen M, Budäus L. Open and robot-assisted radical retropubic prostatectomy in men receiving ongoing low-dose aspirin medication: revisiting an old paradigm? BJU Int. 2014 Sep;114(3):396-403. doi: 10.1111/bju.12504. Epub 2014 Jul 15. Review.

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Ono K, Idani H, Hidaka H, Kusudo K, Koyama Y, Taguchi S. Effect of aspirin continuation on blood loss and postoperative morbidity in patients undergoing laparoscopic cholecystectomy or colorectal cancer resection. Surg Laparosc Endosc Percutan Tech. 2013 Feb;23(1):97-100. doi: 10.1097/SLE.0b013e318278cdf8.

Oscarsson A, Gupta A, Fredrikson M, Järhult J, Nyström M, Pettersson E, Darvish B, Krook H, Swahn E, Eintrei C. To continue or discontinue aspirin in the perioperative period: a randomized, controlled clinical trial. Br J Anaesth. 2010 Mar;104(3):305-12. doi: 10.1093/bja/aeq003.

Partridge CG, Campbell JH, Alvarado F. The effect of platelet-altering medications on bleeding from minor oral surgery procedures. J Oral Maxillofac Surg. 2008 Jan;66(1):93-7.

Zigdon H, Levin L, Filatov M, Oettinger-Barak O, Machtei EE. Intraoperative bleeding during open flap debridement and regenerative periodontal surgery. J Periodontol. 2012 Jan;83(1):55-60. doi: 10.1902/jop.2011.110182. Epub 2011 May 12.

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