Assessment of a disposable trocar for insertion ...

Background: Reusable stainless steel trocars have traditionally been used to insert levonorgestrel-releasing contraceptive implants, yet they are cumbersome to maintain because of sterilization requirements. In addition, sterilization equipment is not always available in many settings and inadequate cleaning could lead to HIV transmission.

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Study design: A new disposable trocar for two-rod implants [i.e., Sino-implant (II) and Jadelle] was compared to a traditional reusable two-rod trocar. Clinicians in Kenya assessed the trocars in terms of ease of use, malfunctions and adverse events.

Results: Eighty insertions were done with the new disposable trocar and 80 insertions were done with the traditional reusable trocar; no differences in performance were found. The disposable trocar was easy to use, did not malfunction and did not cause adverse patient events. These clinical data, combined with the review of the product technical file and an inspection of the manufacturing facility by a Norwegian certification body (Det Norske Veritas), resulted in obtaining the CE Mark, a mandatory conformity mark for the distribution of this medical device in European Union member states.

Conclusions: Disposable trocars eliminate the need for sterilization; this will facilitate provision of contraceptive implants in resource-constrained settings and may decrease the risk of HIV transmission. Combined with recent reduction in prices of implants, these new developments should increase access to this important contraceptive technology in many parts of the world.

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5mm, 10mm, 12mm diameters

110mm Length

Available with 1 or 2 Cannulas

Uses

• Instrument Access: Provides a port through which laparoscopic instruments, such as scissors, graspers, or cameras, can be introduced into the abdomen.
• Insufflation: Allows for the introduction of gas (usually CO&#;) to inflate the abdominal cavity, creating space for the surgeon to operate.
• Multiple Sizes: Available in various diameters (5mm, 10mm, 12mm) to accommodate different instruments and procedures.

Advantages of Disposable Trocars

1. Sterility: Each trocar is sterile out of the package, reducing the risk of infection.
2. Convenience: No need for reprocessing or sterilization between uses, saving time and resources.
3. Safety: New, sharp obturators reduce the risk of tissue trauma during insertion compared to potentially dulled reusable devices.
4. Cost-Effective: Despite being single-use, the overall costs can be lower when considering the expenses associated with sterilizing reusable trocars and the potential costs related to infections.

Typical Procedures

• Cholecystectomy: Removal of the gallbladder.
• Appendectomy: Removal of the appendix.
• Hernia Repair: Repairing abdominal hernias.
• Gynecologic Surgeries: Such as hysterectomy or oophorectomy.
• Bariatric Surgery: Weight-loss surgeries like gastric bypass or sleeve gastrectomy.

Usage Protocol

1. Insertion: The trocar, with the obturator in place, is inserted through a small incision in the abdomen.
2. Establishing Pneumoperitoneum: CO&#; is insufflated to inflate the abdominal cavity.
3. Instrument Insertion: The obturator is removed, and laparoscopic instruments are introduced through the cannula.
4. Procedure: The surgeon performs the necessary surgical tasks.
5. Removal: The trocar and instruments are removed at the end of the procedure, and the incisions are closed.

Disposal

After the procedure, the disposable trocar is safely discarded according to medical waste disposal protocols to prevent any risk of contamination or infection.

Using disposable laparoscopic trocars has become standard practice in many surgical settings due to their convenience, safety, and efficiency in minimizing infection risks.