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

NCT ID: NCT02084615

Last Updated: 2015-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Hernia, Inguinal Postoperative Complications Postoperative Hemorrhage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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81mg aspirin

This arm will include perioperative 81 mg of aspirin.

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

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

325mg aspirin

Subjects will be taking 325mg of aspirin.

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

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

Interventions

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Aspirin

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

Intervention Type DRUG

Other Intervention Names

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acetylsalicylic acid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Jesse Brown VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Joseph Vitello, MD

Interim Chief of Surgical Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph M Vitello, MD

Role: PRINCIPAL_INVESTIGATOR

Jesse Brown VA Medical Center

Locations

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Jesse Brown VA Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Antolovic D, Rakow A, Contin P, Ulrich A, Rahbari NN, Buchler MW, Weitz J, Koch M. A randomised controlled pilot trial to evaluate and optimize the use of anti-platelet agents in the perioperative management in patients undergoing general and abdominal surgery--the APAP trial (ISRCTN45810007). Langenbecks Arch Surg. 2012 Feb;397(2):297-306. doi: 10.1007/s00423-011-0867-7. Epub 2011 Nov 3.

Reference Type BACKGROUND
PMID: 22048442 (View on PubMed)

Binhas M, Salomon L, Roudot-Thoraval F, Armand C, Plaud B, Marty J. Radical prostatectomy with robot-assisted radical prostatectomy and laparoscopic radical prostatectomy under low-dose aspirin does not significantly increase blood loss. Urology. 2012 Mar;79(3):591-5. doi: 10.1016/j.urology.2011.11.031.

Reference Type BACKGROUND
PMID: 22386405 (View on PubMed)

Burger W, Chemnitius JM, Kneissl GD, Rucker G. Low-dose aspirin for secondary cardiovascular prevention - cardiovascular risks after its perioperative withdrawal versus bleeding risks with its continuation - review and meta-analysis. J Intern Med. 2005 May;257(5):399-414. doi: 10.1111/j.1365-2796.2005.01477.x.

Reference Type BACKGROUND
PMID: 15836656 (View on PubMed)

Chechik O, Goldstein Y, Behrbalk E, Kaufman E, Rabinovich Y. Blood loss and complications following carotid endarterectomy in patients treated with clopidogrel. Vascular. 2012 Aug;20(4):193-7. doi: 10.1258/vasc.2011.oa0336. Epub 2012 May 10.

Reference Type BACKGROUND
PMID: 22577162 (View on PubMed)

Gerstein NS, Schulman PM, Gerstein WH, Petersen TR, Tawil I. Should more patients continue aspirin therapy perioperatively?: clinical impact of aspirin withdrawal syndrome. Ann Surg. 2012 May;255(5):811-9. doi: 10.1097/SLA.0b013e318250504e.

Reference Type BACKGROUND
PMID: 22470078 (View on PubMed)

Kang SB, Cho KJ, Moon KH, Jung JH, Jung SJ. Does low-dose aspirin increase blood loss after spinal fusion surgery? Spine J. 2011 Apr;11(4):303-7. doi: 10.1016/j.spinee.2011.02.006.

Reference Type BACKGROUND
PMID: 21474081 (View on PubMed)

Leyh-Bannurah SR, Hansen J, Isbarn H, Steuber T, Tennstedt P, Michl U, Schlomm T, Haese A, Heinzer H, Huland H, Graefen M, Budaus 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.

Reference Type BACKGROUND
PMID: 24127902 (View on PubMed)

Madan GA, Madan SG, Madan G, Madan AD. Minor oral surgery without stopping daily low-dose aspirin therapy: a study of 51 patients. J Oral Maxillofac Surg. 2005 Sep;63(9):1262-5. doi: 10.1016/j.joms.2005.05.164.

Reference Type BACKGROUND
PMID: 16122588 (View on PubMed)

Manning BJ, O'Brien N, Aravindan S, Cahill RA, McGreal G, Redmond HP. The effect of aspirin on blood loss and transfusion requirements in patients with femoral neck fractures. Injury. 2004 Feb;35(2):121-4. doi: 10.1016/s0020-1383(03)00073-1.

Reference Type BACKGROUND
PMID: 14736467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23386161 (View on PubMed)

Oscarsson A, Gupta A, Fredrikson M, Jarhult J, Nystrom 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.

Reference Type BACKGROUND
PMID: 20150346 (View on PubMed)

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. doi: 10.1016/j.joms.2005.11.055.

Reference Type BACKGROUND
PMID: 18083421 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21563946 (View on PubMed)

Other Identifiers

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2013-0976

Identifier Type: -

Identifier Source: org_study_id

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