Review of Efficacy of Used ultraSonic Energy Device (REUSED)

May 14, 2020 updated by: Jakov Mihanovic, University of Split, School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 23000
        • Clinical Hospital Split
      • Zadar, Croatia, 23000
        • General Hospital Zadar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: New Device
Laparoscopic appendectomy will be done using new ultrasonic shears.
Device: New Device
Laparoscopic appendectomy using new ultrasonic shears.
Experimental: Used Device
Laparoscopic appendectomy will be done using reprocessed ultrasonic shears.
Device: Used Device
Laparoscopic appendectomy using reprocessed ultrasonic shears.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lateral Thermal Damage of Mesoappendix
Time Frame: Through study completion, an average of 1 year.
Microscopically measured distance of lateral thermal damage of mesoappendix
Through study completion, an average of 1 year.
Lateral Thermal Damage of Appendiceal Base
Time Frame: Through study completion, an average of 1 year.
Microscopically measured distance of lateral thermal damage of appendiceal base
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome - Postoperative complications
Time Frame: Postoperative 30 days follow-up
Clavien Dindo classification of postoperative complications
Postoperative 30 days follow-up
Clinical outcome - Length of stay
Time Frame: Through study completion, an average of 1 year.
In-hospital stay in days
Through study completion, an average of 1 year.
Time to transect appendiceal base
Time Frame: During the surgery
Speed of transection of appendiceal base regarding its diameter in seconds
During the surgery
Rating Device Functionality
Time Frame: Immediately after surgery

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

Collaborators

University Hospital of Split
General Hospital Zadar

Investigators

  • Principal Investigator: Jakov Mihanovic, MD, General Hospital Zadar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2019

Primary Completion (Actual)

April 13, 2020

Study Completion (Actual)

May 14, 2020

Study Registration Dates

First Submitted

December 28, 2019

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REUSED2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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