2012

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

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

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

METHODS:
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.

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

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