Middle-term Outcomes of Gatekeeper Implantation for Fecal Incontinence

Brusciano L., Tolone S., Del Genio G. et al.
Diseases of the Colon & Rectum: April 2020 - 63 (4): 514-519

Intersphincteric injectable bulking agents are one of the current treatment options for fecal incontinence, failing behavioral and medical therapy. Gatekeeper showed promising short-term results, but long-term outcomes are unknown.

The purpose of this study was to clinically evaluate a prospective cohort of fecal incontinence patients up to 36 months after implantation of Gatekeeper.

The study was conducted at a large university tertiary care hospital. 

Consecutive female patients were eligible if fecal incontinence onset was ≥6 months before the first visit and symptoms were refractory to standard conservative measures.

All of the patients underwent implantation of 4 or 6 Gatekeeper prostheses. Three-dimensional endoanal ultrasonography and high-resolution anorectal manometry were performed preoperatively and postoperatively at 2 and 3 months after implantation.

The Cleveland Clinic Fecal Incontinence score was calculated at baseline and 1, 3, 12, 24, and 36 months postoperatively.

Twenty patients (all women; median age, 59 y) were enrolled, and all implants were uneventful. Postoperative endoanal ultrasonography showed normal prosthesis localization in 16 patients (80%). At manometry, mean anal resting pressure significantly improved (57.8 ± 7.5 mm Hg; p = 0.0004). Mean preoperative Cleveland Clinic Fecal Incontinence score was 12.4 ± 1.8, with significant improvements initially documented at 3 months (4.9 ± 1.5; p < 0.0001) and sustained up to 36 months (4.9 ± 1.7; p < 0.0001). Patients receiving only 4 (compared with 6) prostheses and those experiencing pudendal neuropathy (compared with those who did not) showed significantly higher Cleveland Clinic Fecal Incontinence score values in the middle term.