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
COMPLETED
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-05-27
Study Completion Date
2020-05-14
Brief Summary
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Single-use medical instruments are intended by the manufacturers for single-use only or for single-patient-use only. Nevertheless, single-use instruments are being reused more than once in many countries around the world. The reasons are mainly economic in developing countries and environmental in developed countries. Concerns are being raised regarding reused instruments sterility and efficacy. Since there is paucity of evidence on safety of multiple use of single-use instruments in surgery, we decided to conduct a clinical study comparing the same surgical procedure performed with new versus reused surgical instrument. We decided to study laparoscopic appendectomy which is a simple and the most common emergency surgery. Instrument under the scrutiny is ultrasonic scalpel which uses high-frequency ultrasound vibration for coagulating and cutting tissue. In the studied period of time, all eligible patients with acute appendicitis will be randomized in two groups, first having surgery with new device and the second having surgery with reused device. Removed appendix will be analyzed for lateral thermal damage and the patients will be followed-up for one month for potential differences in clinical outcomes like pain-killers consumption, length of stay and postoperative complications.
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Detailed Description
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Laparoscopic appendectomy provides enhanced recovery at increased costs due to a need for a specific sophisticated equipment. Currently many of the commonly used devices are labeled by manufacturers as single-use only. This trend has stronghold in concerns about patient safety, especially about prevention of cross-infections and other safety-related issues. On the other hand, surgery costs are increased exponentially. There is paucity of evidence on safety of reusing single-use devices (SUD) in surgery. Reuse of SUD which may include refurbishing or reprocessing and resterilization is a complex issue with moral, technical, economical and environmental repercussions. There are several papers discussing the ethical dilemmas involved. The reprocessed instruments are generally deemed equally safe as new one. However there are only few experimental and clinical studies on this topic. Most of them are influenced by sponsors or manufacturers and therefore biased. What's more their conclusions are sometimes highly controversial. Goal of this study is to provide solid evidence on safety of reuse of SUD and to discover differences in in-vitro and clinical outcomes. One of the most common SUD for laparoscopic surgery is ultrasonic scalpel which uses high-frequency jaw vibration which simultaneously coagulates and divides structures with minimal thermal damage to surrounding tissue. One of the best known ultrasonic shears intended for single-use is harmonic scalpel (Ultracision® Ethicon EndoSurgery, Johnson\&Johnson Company). Ultrasonic shears are being refurbished and/or resterilized for repetitive use in limited number of cycles or until become dysfunctional or disintegrate. Routine depends on local regulations and variations in practice. To encourage or to ban aforementioned practice we need solid evidence based on properly conducted clinical trial. Therefore we have designed a single-blind randomised clinical trial depending on virginity of instrument used for tissue dissection. Since Ultracision device is the most commonly used ultrasonic sealing device we decided to study outcomes of surgery performed with the new (unused) instrument versus resterilized reused instrument.
All of the patients with clinical and radiological suspicion of having acute appendicitis will be blindly allocated in two arms according to the predefined random sequence provided by independent statistician. Eligible patients will sign an informed consent form. First arm will have laparoscopic appendectomy with new ultrasonic device. The patient will be blinded for the allocation, but the surgeon can not be blinded since packing of the new and reused instruments differ. Even if the scrub nurse would give surgeon instruments without packing, some minor damage might be seen on the plastic coating of the instrument jaws. The second arm will have laparoscopic appendectomy with reused ultrasonic device. All other treatment including surgical technique, postoperative management and follow-up will be unchanged or within the standard of care. Surgical technique is standardised three-trocar approach in general anesthesia. All other details of the surgery are variable depending on local findings, extent of inflammation, anatomy variations etc. Removed specimens will be analyzed routinely with addition of measurement of lateral thermal damage of mesoappendix and appendiceal base. Patients will be screened for antibiotic therapy length, analgesics consumption, early surgical complications according to Clavien-Dindo classification and length of stay. Additionally one month follow-up will be conducted to pick-up possible late complications or readmissions. Study will be conducted in two centers for a period of time until sufficient number of participants are recruited.
All of the patients with clinical and radiological suspicion of having acute appendicitis will be blindly allocated in two arms according to the predefined random sequence provided by independent statistician. Eligible patients will sign an informed consent form. First arm will have laparoscopic appendectomy with new ultrasonic device. The patient will be blinded for the allocation, but the surgeon can not be blinded since packing of the new and reused instruments differ. Even if the scrub nurse would give surgeon instruments without packing, some minor damage might be seen on the plastic coating of the instrument jaws. The second arm will have laparoscopic appendectomy with reused ultrasonic device. All other treatment including surgical technique, postoperative management and follow-up will be unchanged or within the standard of care. Surgical technique is standardised three-trocar approach in general anesthesia. All other details of the surgery are variable depending on local findings, extent of inflammation, anatomy variations etc. Removed specimens will be analyzed routinely with addition of measurement of lateral thermal damage of mesoappendix and appendiceal base. Patients will be screened for antibiotic therapy length, analgesics consumption, early surgical complications according to Clavien-Dindo classification and length of stay. Additionally one month follow-up will be conducted to pick-up possible late complications or readmissions. Study will be conducted in two centers for a period of time until sufficient number of participants are recruited.
Conditions
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Appendicitis Acute
Safety Issues
Complication of Surgical Procedure
Device Induced Injury
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants will be randomized to laparoscopic appendectomy with new ultrasonic shears versus laparoscopic appendectomy with reused ultrasonic shears. Randomization sequence will be issued by independent statistician and the participants will be blinded to the surgical instrument used for laparoscopic appendectomy.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Participants will be blinded to allocation and instrument used for surgery, with the same clinical treatment and postoperative follow-up.
Study Groups
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New Device
Laparoscopic appendectomy will be done using new ultrasonic shears.
Group Type
ACTIVE_COMPARATOR
New Device
Intervention Type
DEVICE
Laparoscopic appendectomy using new ultrasonic shears.
Used Device
Laparoscopic appendectomy will be done using reprocessed ultrasonic shears.
Group Type
EXPERIMENTAL
Used Device
Intervention Type
DEVICE
Laparoscopic appendectomy using reprocessed ultrasonic shears.
Interventions
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New Device
Laparoscopic appendectomy using new ultrasonic shears.
Intervention Type
DEVICE
Used Device
Laparoscopic appendectomy using reprocessed ultrasonic shears.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of acute appendicitis confirmed during surgery
* Laparoscopic appendectomy
* Operated with UltraCision harmonic scalpel.
* Laparoscopic appendectomy
* Operated with UltraCision harmonic scalpel.
Exclusion Criteria
* Finding of innocent (white) appendix
* Pregnancy
* Significant co-morbidity (ASA III-IV)
* Open appendectomy
* Laparoscopic appendectomy using instruments other than Ultracision harmonic scalpel.
* Pregnancy
* Significant co-morbidity (ASA III-IV)
* Open appendectomy
* Laparoscopic appendectomy using instruments other than Ultracision harmonic scalpel.
Minimum Eligible Age
5 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital of Split
OTHER
Sponsor Role
collaborator
General Hospital Zadar
OTHER
Sponsor Role
collaborator
University of Split, School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Jakov Mihanovic
Jakov Mihanovic, Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jakov Mihanovic, MD
Role: PRINCIPAL_INVESTIGATOR
General Hospital Zadar
Locations
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Clinical Hospital Split
Split, , Croatia
Site Status
General Hospital Zadar
Zadar, , Croatia
Site Status
Countries
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Croatia
References
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Chu T, Chandhoke RA, Smith PC, Schwaitzberg SD. The impact of surgeon choice on the cost of performing laparoscopic appendectomy. Surg Endosc. 2011 Apr;25(4):1187-91. doi: 10.1007/s00464-010-1342-1. Epub 2010 Sep 11.
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Dunn D. Reprocessing single-use devices--the ethical dilemma. AORN J. 2002 May;75(5):989-99; quiz 1000-4. doi: 10.1016/s0001-2092(06)61462-2.
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Collier R. The ethics of reusing single-use devices. CMAJ. 2011 Aug 9;183(11):1245. doi: 10.1503/cmaj.109-3907. Epub 2011 Jul 11. No abstract available.
Reference Type
BACKGROUND
Lester BR, Miller K, Boers A, Harris DC, Gamble WG. Comparison of in vivo clinical performance and shaft temperature and in vitro tissue temperature and transection times between new and reprocessed harmonic scalpels. Surg Laparosc Endosc Percutan Tech. 2010 Oct;20(5):e150-9. doi: 10.1097/SLE.0b013e3181eff973.
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Weld KJ, Dryer S, Hruby G, Ames CD, Venkatesh R, Matthews BD, Landman J. Comparison of mechanical and in vivo performance of new and reprocessed harmonic scalpels. Urology. 2006 May;67(5):898-903. doi: 10.1016/j.urology.2005.11.027.
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Manatakis DK, Georgopoulos N. Reducing the Cost of Laparoscopy: Reusable versus Disposable Laparoscopic Instruments. Minim Invasive Surg. 2014;2014:408171. doi: 10.1155/2014/408171. Epub 2014 Jul 22.
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Druzijanic N, Pogorelic Z, Perko Z, Mrklic I, Tomic S. Comparison of lateral thermal damage of the human peritoneum using monopolar diathermy, Harmonic scalpel and LigaSure. Can J Surg. 2012 Oct;55(5):317-21. doi: 10.1503/cjs.000711.
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Pogorelic Z, Katic J, Mrklic I, Jeroncic A, Susnjar T, Jukic M, Vilovic K, Perko Z. Lateral thermal damage of mesoappendix and appendiceal base during laparoscopic appendectomy in children: comparison of the harmonic scalpel (Ultracision), bipolar coagulation (LigaSure), and thermal fusion technology (MiSeal). J Surg Res. 2017 May 15;212:101-107. doi: 10.1016/j.jss.2017.01.014. Epub 2017 Jan 28.
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Colak T, Ersoz G, Akca T, Kanik A, Aydin S. Efficacy and safety of reuse of disposable laparoscopic instruments in laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2004 May;18(5):727-31. doi: 10.1007/s00464-004-8112-x. Epub 2004 Mar 19.
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Ramshaw BJ. Reusing disposal laparoscopic instruments. Surg Endosc. 2004 Aug;18(8):1161-2. doi: 10.1007/s00464-004-8203-8. Epub 2004 Jul 7. No abstract available.
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Chan AC, Ip M, Koehler A, Crisp B, Tam JS, Chung SC. Is it safe to reuse disposable laparoscopic trocars? An in vitro testing. Surg Endosc. 2000 Nov;14(11):1042-4. doi: 10.1007/s004640000118.
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Lopes Cde L, Graziano KU, Pinto Tde J. Evaluation of single-use reprocessed laparoscopic instrument sterilization. Rev Lat Am Enfermagem. 2011 Mar-Apr;19(2):370-7. doi: 10.1590/s0104-11692011000200020. English, Portuguese, Spanish.
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Bruning LM. Disposables v. reusables in OR practice: Part I, Weighing contributions to patient care. Nurs Manage. 1992 Feb;23(2):80J-80K, 80N, 80P. doi: 10.1097/00006247-199202000-00026. No abstract available.
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Gartner D, Munz K, Huckelheim E, Hesse U. Ultrasound scissors: new single-use instruments vs. resterilised single-use instruments - a prospective randomised study. GMS Krankenhhyg Interdiszip. 2008 Sep 3;3(3):Doc20.
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Siu J, Hill AG, MacCormick AD. Systematic review of reusable versus disposable laparoscopic instruments: costs and safety. ANZ J Surg. 2017 Jan;87(1-2):28-33. doi: 10.1111/ans.13856. Epub 2016 Nov 23.
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Renton D, Denk P, Varban O. Reprocessed single-use devices in laparoscopy: assessment of cost, environmental impact, and patient safety. Surg Endosc. 2018 Oct;32(10):4310-4313. doi: 10.1007/s00464-018-6275-0. Epub 2018 Jun 15. No abstract available.
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Brady JT, Bhakta A, Steele SR, Trunzo JA, Senagore AJ, Holmgren K, Schillero A, Champagne BJ. Reprocessed bipolar energy for laparoscopic colectomy: Is it worth it? Am J Surg. 2017 Jul;214(1):59-62. doi: 10.1016/j.amjsurg.2017.02.012. Epub 2017 Feb 20.
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BACKGROUND
Mihanovic J, Sikic NL, Mrklic I, Katusic Z, Karlo R, Jukic M, Jeroncic A, Pogorelic Z. Comparison of new versus reused Harmonic scalpel performance in laparoscopic appendectomy in patients with acute appendicitis-a randomized clinical trial. Langenbecks Arch Surg. 2021 Feb;406(1):153-162. doi: 10.1007/s00423-020-02039-y. Epub 2020 Nov 25.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
https://www.nlcahr.mun.ca/CHRSP/SUDS_full_web.pdf
The Reprocessing and Reuse of Single-Use Medical Devices in Newfoundland \& Labrador (2010)
http://www.amdr.org/wp-content/uploads/2010/09/White-Paper-Safety-and-Performance-Eval-of-Remfd-Harmonic-Scalpels.pdf
Safety and performance evaluation of remanufactured harmonic scalpels (2010)
https://www.zakon.hr/z/1253/Zakon-o-provedbi-Uredbe-%28EU%29-2017-745-o-medicinskim-proizvodima-i-Uredbe-%28EU%29-2017-746-o-in-vitro-dijagnostičkim-medicinskim-proizvodima
Croatian Law on Medical Products 2017/745 (2018) - Article in Croatian
http://www.glas-slavonije.hr/189637/3/Jednokratna-oprema-za-operacije-ce-se-sterilizirati-i-ponovno-koristiti
Newspaper article in Croatian part 1
http://www.glas-slavonije.hr/190133/1/Zaustavljena-sterilizacija-jednokratnih--instrumenata
Newspaper article in Croatian part 2
Other Identifiers
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REUSED2019
Identifier Type: -
Identifier Source: org_study_id
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