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Novel bulking agent for faecal incontinence.
1Department of Surgical Sciences, Catholic University, Rome, Italy. carloratto@tiscali.it
The British Journal of Surgery
|September 20, 2011
Summary
The Gatekeeper™ anal implant offers a safe and effective treatment for fecal incontinence (FI), significantly reducing symptoms and improving quality of life over medium-term follow-up.
Area of Science:
- Gastroenterology
- Colorectal Surgery
- Medical Devices
Background:
- Injectable bulking agents for fecal incontinence (FI) often show waning efficacy.
- A novel bulking agent, Gatekeeper™, was evaluated for sustained treatment of FI.
Purpose of the Study:
- To assess the short- and medium-term effectiveness and safety of the Gatekeeper™ anal implant for treating fecal incontinence.
Main Methods:
- Fourteen patients with FI received Gatekeeper™ implants in the intersphincteric space under ultrasound guidance.
- Outcomes measured included FI episodes, Cleveland Clinic FI Score (CCFIS), Vaizey score, anorectal manometry, endoanal ultrasonography (EUS), and quality of life questionnaires.
Main Results:
- Significant reductions in major FI episodes (P = 0.002) and improvements in CCFIS (P < 0.001) and Vaizey scores (P = 0.010) were observed.
- Patients reported enhanced quality of life, improved soiling, and better ability to postpone defecation.
- No complications or prosthesis dislocations were noted on follow-up (mean 33.5 months).
Conclusions:
- The Gatekeeper™ anal implant demonstrates safety, reliability, and sustained efficacy in treating fecal incontinence.
- The initial improvements achieved with Gatekeeper™ are maintained over medium-term follow-up, indicating encouraging results.
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