Gatekeeper™ Prostheses Implants in the Anal Canal for Gas Incontinence and Soiling: Long-Term Follow-Up.

Area of Science:

• Gastroenterology
• Colorectal Surgery
• Medical Devices

Background:

• Fecal incontinence (FI), particularly gas incontinence (GI) and soiling, presents management challenges.
• Existing treatments offer limited efficacy for these specific FI subtypes.

Purpose of the Study:

• To evaluate the safety and efficacy of the Gatekeeper™ device for treating fecal incontinence with predominant soiling and/or gas incontinence.
• To assess patient-reported outcomes and objective measures of continence post-intervention.

Main Methods:

• A prospective, single-center case series involving 13 patients treated with polyacrylonitrile prostheses (Gatekeeper™).
• Continence was assessed using diaries, St. Mark's score, Visual Analogue Scale (VAS), 3D-Endoanal Ultrasound, and Anorectal Manometry at baseline and follow-up intervals up to 24 months.
• Key outcome measures included reduction in soiling and GI episodes and patient satisfaction.

Main Results:

• The Gatekeeper™ implant procedure was uneventful in all patients.
• Significant reductions in soiling and GI episodes were observed at 1 year (p=0.002 for soiling, p=0.01 for GI).
• Patient-reported outcomes showed significant improvement in VAS scores (p=0.03), with 70% of patients willing to repeat the treatment.

Conclusions:

• Gatekeeper™ is a safe and minimally invasive option for managing fecal incontinence, specifically soiling and gas incontinence.
• The device demonstrated a significant reduction in symptoms, with a notable improvement in soiling.
• Further studies are warranted to confirm these findings in a larger cohort of patients with this specific FI subtype.