Review of Efficacy of Used ultraSonic Energy Device
Condition: Appendicitis Acute; Safety Issues; Complication of Surgical Procedure; Device Induced Injury
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): New Device; Used Device
Intervention type(s): Device; Device
Intervention description(s): Laparoscopic appendectomy using new ultrasonic shears.; Laparoscopic appendectomy using reprocessed ultrasonic shears.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Appendectomy; Laparoscopic Surgery; Equipment Reuse; Patient Safety