Injectable Bulking Agent, Dextranomer/Hyaluronic Acid Copolymer Implant, Anal Canal (L8605)

Name of the Procedure:

Common Names: Injectable Bulking Agent, Dextranomer/Hyaluronic Acid Implant
Medical Terms: L8605, Dextranomer/Hyaluronic Acid Copolymer Implantation

Summary

This procedure involves injecting a substance made of dextranomer and hyaluronic acid into the anal canal to treat certain types of fecal incontinence. It aims to bulk up the tissues, providing better control over bowel movements.

Purpose

• Medical Conditions Addressed: Treats fecal incontinence.
• Goals/Outcomes: Improve bowel control and reduce instances of fecal leakage.

Indications

• Symptoms/Conditions: Chronic fecal incontinence, particularly when other treatments have failed.
• Patient Criteria: Suitable for patients experiencing moderate to severe fecal incontinence who have not responded well to lifestyle changes or medications.

Preparation

• Pre-Procedure Instructions: Patients may be advised to fast for a specific period before the procedure. Medication adjustments might be needed.
• Diagnostic Tests/Assessments: Pre-procedure evaluations may include physical exams, anorectal manometry, and imaging studies.

Procedure Description

1. Preparation: The patient is prepared in a sterile environment.
2. Anesthesia: Local anesthesia is typically applied to minimize discomfort.
3. Insertion: A specialized needle is used to inject the dextranomer/hyaluronic acid copolymer into the submucosal layer of the anal canal.
4. Placement: The bulking agent is carefully injected to ensure it forms a cushion-like structure, enhancing the anal closure.

• Tools/Equipment: Injection needle, syringe, dextranomer/hyaluronic acid copolymer.
• Anesthesia/Sedation: Local anesthesia; more extensive sedation is rare but possible.

Duration

The procedure typically takes about 30 to 60 minutes.

Setting

Usually performed in an outpatient clinic or a specialized surgical center.

Personnel

• Surgeons or specialized healthcare providers trained in fecal incontinence treatments.
• Nurses for procedural assistance and patient care.
• Occasionally, anesthesiologists or nurse anesthetists if sedation beyond local anesthesia is required.

Risks and Complications

• Common Risks: Minor bleeding, temporary pain at the injection site, minor infection.
• Rare Risks: Allergic reactions, migration of the bulking agent, significant infection.
• Complication Management: Most complications are managed with medications and monitoring.

Benefits

• Expected Benefits: Improved bowel control, reduced fecal leakage.
• Realization Timeframe: Benefits are typically noted within a few weeks post-procedure.

Recovery

• Post-Procedure Care: Rest for the remainder of the day, mild activity the following day.
• Recovery Time: Minimal, usually within a few days.
• Restrictions: Light activity for a few days, avoid strenuous activities.
• Follow-Up: Routine follow-up appointments to monitor progress and address any concerns.

Alternatives

• Other Treatments: Dietary changes, pelvic floor exercises, medications, sacral nerve stimulation, surgical sphincter repair.
• Pros and Cons of Alternatives:
  • Dietary and Lifestyle Changes: Non-invasive, no risk of surgical complications, but may be less effective for severe cases.
  • Medications: Low-risk, but may have side effects and variable efficacy.
  • Surgical Options: Potentially longer-lasting results but higher risk and more invasive.

Patient Experience

• During the Procedure: Minimal discomfort due to local anesthesia, might feel pressure or mild pain.
• After the Procedure: Mild soreness, possible minor bleeding or temporary discomfort managed with over-the-counter pain relief.
• Pain Management: Over-the-counter pain relievers like acetaminophen or ibuprofen typically suffices.

This document is intended to provide a comprehensive overview of the dextranomer/hyaluronic acid copolymer implantation procedure, covering essential aspects to ensure patients and healthcare providers are well informed.