Safety Issues Clinical Trial
— REUSEDOfficial title:
Comparison of Lateral Thermal Damage and Clinical Outcomes of Laparoscopic Appendectomy With New Versus Reused Ultrasonic Scalpel in Patients With Acute Appendicitis - Randomized Clinical Trial
NCT number | NCT04226482 |
Other study ID # | REUSED2019 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 27, 2019 |
Est. completion date | May 14, 2020 |
Verified date | May 2020 |
Source | University of Split, School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 14, 2020 |
Est. primary completion date | April 13, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of acute appendicitis confirmed during surgery - 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. |
Country | Name | City | State |
---|---|---|---|
Croatia | Clinical Hospital Split | Split | |
Croatia | General Hospital Zadar | Zadar |
Lead Sponsor | Collaborator |
---|---|
University of Split, School of Medicine | General Hospital Zadar, University Hospital of Split |
Croatia,
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lateral Thermal Damage of Mesoappendix | Microscopically measured distance of lateral thermal damage of mesoappendix | Through study completion, an average of 1 year. | |
Primary | Lateral Thermal Damage of Appendiceal Base | Microscopically measured distance of lateral thermal damage of appendiceal base | Through study completion, an average of 1 year. | |
Secondary | Clinical outcome - Postoperative complications | Clavien Dindo classification of postoperative complications | Postoperative 30 days follow-up | |
Secondary | Clinical outcome - Length of stay | In-hospital stay in days | Through study completion, an average of 1 year. | |
Secondary | Time to transect appendiceal base | Speed of transection of appendiceal base regarding its diameter in seconds | During the surgery | |
Secondary | Rating Device Functionality | Rating of Surgeon's satisfaction with ultrasonic shears' performance using Performance Evaluation Scale (PES) where: 1 is unacceptable, 2 is acceptable, 3 is optimal. PES has 5 categories: 1. Hemostasis, 2. Coagulation effect, 3. Cutting effect, 4. Instrument activation force, 5. Disturbing sounds. |
Immediately after surgery |
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