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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02084615
• Other study ID #: 2013-0976
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 9, 2014
• Last updated: June 16, 2015
• Start date: August 2014
• Est. completion date: June 2017

Study information

• Verified date: June 2015
• Source: Jesse Brown VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: June 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Hernia
• Hernia, Inguinal
• Postoperative Complications
• Postoperative Hemorrhage

Intervention

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

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Jesse Brown VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

Antolovic D, Rakow A, Contin P, Ulrich A, Rahbari NN, Büchler 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. — View Citation

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. — View Citation

Burger W, Chemnitius JM, Kneissl GD, Rücker 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative blood loss	intraoperative blood loss will be accurately measured among the three arms of the study	intraoperative only	Yes
Secondary	Number of Participants with Serious and Non-Serious Adverse Events	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	30 days post operative	Yes