Gatekeeper in fecal incontinence: prospective European multicentre study

Ratto C., Buntzen S., Ganio E., Altomare D.F., De La Portilla F. & Aigner F.
Trial Symposium T3, ESCP Meeting 2012, Wien

Use of bulking agents in patients with faecal incontinence (FI) is still controversial.

To evaluate clinical efficacy, feasibility, safety, impact on QoL and manometry of GateKeeper implant.

Patients’ selection based on: patients’ history, physical examination, continence diary, anorectal manometry, and EAUS. Inclusion: Patients with FI (soiling or incontinence to liquid/solid stools) more than once a week since ≥ 6 months; intact anal sphincters or IAS lesion with maximum circumferential extension of 60°. Major exclusion criteria: current anorectal infection, diabetes, IBDs; ano-rectal dismotility; previous surgery for FI; colorectal cancer in treatment; rectal bleeding; chronic diarrhoea; constipation; EAS lesion; urgency without EAS lesion; full-thickness rectal prolapse; IV-degree haemorrhoids; severe anal scarring. Enrolment: Seventy patients (final minimum number of 60 patients). Surgery: Under locoregional or general anaesthesia, intersphincteric implantation of six GateKeeper prostheses, using the THD® Gatekeeper Delivery System (THD S.p.A., Correggio, Italy). Follow up: Clinical evaluation, anorectal manometry, and EAUS scheduled on postoperative day 30, and 90; Cleveland Clinical FI, Vaizey, and AMS scores, SF36 and FIQL questionnaires collected on postoperative day 30 and 90. Adverse events will be recorded.

Results on this trial could confirm the short-term efficacy of Gatekeeper to treat selected FI patients.