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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Joseph Vitello, MD, Jesse Brown VA Medical Center
ClinicalTrials.gov Identifier:
NCT02084615
First received: March 9, 2014
Last updated: June 16, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Hernia, Inguinal
Postoperative Complications
Postoperative Hemorrhage
Drug: Aspirin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Nonrandomized, Study Comparing the Use of Aspirin and Intraoperative Blood Loss and Postoperative Complications Following Open Inguinal Hernia Repair.

Resource links provided by NLM:


Further study details as provided by Jesse Brown VA Medical Center:

Primary Outcome Measures:
  • intraoperative blood loss [ Time Frame: intraoperative only ] [ Designated as safety issue: Yes ]
    intraoperative blood loss will be accurately measured among the three arms of the study


Secondary Outcome Measures:
  • Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 30 days post operative ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 300
Study Start Date: August 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 81mg aspirin
This arm will include perioperative 81 mg of aspirin.
Drug: Aspirin
Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin
Other Name: acetylsalicylic acid
Experimental: 325mg aspirin
Subjects will be taking 325mg of aspirin.
Drug: Aspirin
Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin
Other Name: acetylsalicylic acid

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02084615

Locations
United States, Illinois
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Jesse Brown VA Medical Center
Investigators
Principal Investigator: Joseph M Vitello, MD Jesse Brown VA Medical Center
  More Information

Publications:

Responsible Party: Joseph Vitello, MD, Interim Chief of Surgical Services, Jesse Brown VA Medical Center
ClinicalTrials.gov Identifier: NCT02084615     History of Changes
Other Study ID Numbers: 2013-0976
Study First Received: March 9, 2014
Last Updated: June 16, 2015
Health Authority: United States: Federal Government

Keywords provided by Jesse Brown VA Medical Center:
Aspirin
Postoperative hemorrhage
Inguinal hernia

Additional relevant MeSH terms:
Hemorrhage
Hernia
Hernia, Inguinal
Postoperative Complications
Postoperative Hemorrhage
Hernia, Abdominal
Pathologic Processes
Pathological Conditions, Anatomical
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 07, 2015