Surgical Complication Nec Clinical Trial
Official title:
Effectiveness of a Radiofrequency Surgical Sponge Detection System for Preventing Retained Surgical Sponges
Verified date | October 2017 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Retained surgical items (e.g. sponges, needles, and instruments) remain the most frequently
reported serious adverse event for five of the last six years. Retained surgical sponges have
resulted in negative patient outcomes (reoperation, readmission/prolonged hospital stay,
infection, fistulas/ bowel obstructions, and death). The national standard for prevention of
retained surgical sponges relies heavily on manual counting several times before, during, and
after the surgical procedure. If a sponge is missing, a series of steps are taken to
reconcile the count. These steps require extra time and pull personnel away from other
competing priorities. If the final closing count remains incorrect, it is common practice to
obtain an intraoperative radiograph to rule out retention of a surgical sponge. This X-Ray is
expensive and increases the time required for the surgery.
Novel technology using a radiofrequency (RF) is now available for detecting and preventing
retained surgical sponges. The objective of this study is to evaluate the in-use
effectiveness of a radiofrequency (RF) surgical sponge detection system for reducing the cost
of searching for sponges and prevention of incorrect counts.
Status | Completed |
Enrollment | 27637 |
Est. completion date | May 31, 2017 |
Est. primary completion date | May 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - We estimate including 27,000 patients during the total of 18 months. 1. The first part of the sample will be retrospective, all patients undergoing surgery in the Main Operating Room during a 9 month period of time of the RF sponge detection system (February through October, 2014) This time frame was selected to allow inclusion of data from our previous study. 2. The second part of the sample will be prospective, for nine months after implementation of the RF sponge detection system. Exclusion Criteria: - ophthalmology, dentistry, non-surgical procedures, aborted surgical procedures, surgeries during which the patient expired, and surgeries performed outside of the Main Operating Room. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Iowa |
Cima RR, Kollengode A, Garnatz J, Storsveen A, Weisbrod C, Deschamps C. Incidence and characteristics of potential and actual retained foreign object events in surgical patients. J Am Coll Surg. 2008 Jul;207(1):80-7. doi: 10.1016/j.jamcollsurg.2007.12.047. Epub 2008 May 23. — View Citation
Dossett LA, Dittus RS, Speroff T, May AK, Cotton BA. Cost-effectiveness of routine radiographs after emergent open cavity operations. Surgery. 2008 Aug;144(2):317-21. doi: 10.1016/j.surg.2008.03.012. Epub 2008 Jun 5. — View Citation
Gawande AA, Studdert DM, Orav EJ, Brennan TA, Zinner MJ. Risk factors for retained instruments and sponges after surgery. N Engl J Med. 2003 Jan 16;348(3):229-35. — View Citation
Guideline for prevention of retained surgical items. In: AORN, ed. Guidelines for Perioperative Practice. 2014 ed. Denver, CO: Association of periOperative Registered Nurses; 2016.
Hart S, Hashemi L, Sobolewski CJ. Effect of a disposable automated suturing device on cost and operating room time in benign total laparoscopic hysterectomy procedures. JSLS. 2013 Oct-Dec;17(4):508-16. doi: 10.4293/108680813X13693422522231. — View Citation
Lincourt AE, Harrell A, Cristiano J, Sechrist C, Kercher K, Heniford BT. Retained foreign bodies after surgery. J Surg Res. 2007 Apr;138(2):170-4. Epub 2007 Feb 1. — View Citation
Rupp CC, Kagarise MJ, Nelson SM, Deal AM, Phillips S, Chadwick J, Petty T, Meyer AA, Kim HJ. Effectiveness of a radiofrequency detection system as an adjunct to manual counting protocols for tracking surgical sponges: a prospective trial of 2,285 patients. J Am Coll Surg. 2012 Oct;215(4):524-33. doi: 10.1016/j.jamcollsurg.2012.06.014. Epub 2012 Jul 6. — View Citation
Steelman VM, Schaapveld AG, Perkhounkova Y, Storm HE, Mathias M. The Hidden Costs of Reconciling Surgical Sponge Counts. AORN J. 2015 Nov;102(5):498-506. doi: 10.1016/j.aorn.2015.09.002. — View Citation
Williams TL, Tung DK, Steelman VM, Chang PK, Szekendi MK. Retained surgical sponges: findings from incident reports and a cost-benefit analysis of radiofrequency technology. J Am Coll Surg. 2014 Sep;219(3):354-64. doi: 10.1016/j.jamcollsurg.2014.03.052. Epub 2014 May 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time spent searching for sponges | The total annualized number of operating room minutes spent searching for missing surgical sponges | 6 months after study start | |
Primary | Cost of time spent searching for sponges | The total annualized cost of operating room time spent searching for sponges | 6 months after study start | |
Primary | Time spent using radiography to rule out the presence of a retained sponge | The total annualized number of operating room minutes spent ruling out the presence of a retained sponge using radiography | 6 months after study start | |
Primary | Cost of using radiography to rule out the presence of a retained sponge | The total annualized cost of operating room time and radiography spent ruling out the presence of a retained sponge | 6 months after study start | |
Primary | Incorrect final counts | The frequency of incorrect final closing counts of surgical sponges. | 6 months after study start |
Status | Clinical Trial | Phase | |
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Enrolling by invitation |
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