Trial record 4 of 65 for:    Open Studies | "Hernia, Inguinal"

Prospective Study Comparing Aspirin Versus Placebo and Blood Loss in Inguinal Hernia Repair

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Jesse Brown VA Medical Center
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: March 11, 2014
Last verified: March 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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.

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: 203
Study Start Date: May 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 81mg aspirin
Subjects will be randomized to one of three arms. This arm will include perioperative 81 mg of aspirin for 7 days preoperatively and 7 days postoperatively.
Drug: Aspirin
Subjects will be randomized to receive either 81mg of aspirin, 325mg of aspirin or placebo
Other Name: acetylsalicylic acid
Experimental: 325mg aspirin
Subjects will be randomized to 325mg of aspirin for 7 days preoperatively and 7 days postoperatively
Drug: Aspirin
Subjects will be randomized to receive either 81mg of aspirin, 325mg of aspirin or placebo
Other Name: acetylsalicylic acid
Placebo Comparator: placebo
Subjects will be randomized to the placebo arm and receive no aspirin
Drug: Placebo
Subjects will be randomized to aspirin or a placebo arm
Other Name: placebo

Detailed Description:

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.

  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

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
  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

Contacts
Contact: Joseph M Vitello, MD 630-234-8214 joseph.vitello@va.gov

Locations
United States, Illinois
Jesse Brown VA Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Joseph M Vitello, MD    630-234-8214    joseph.vitello@va.gov   
Sub-Investigator: Dominic J Vitello         
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, Chief, General Surgery, 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: March 11, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on July 24, 2014