Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
13 participants
OBSERVATIONAL
2014-01-31
2015-12-31
Brief Summary
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The aim of this study is to evaluate Gatekeeper™ treatment for this subgroup of patients with faecal incontinence, not studied before.
Consecutive case series single-centre study. Patients with mainly soiling and/or gas incontinence were treated with polyacrylonitrile prostheses
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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Gatekeeper
Six polyacrylonitrile prostheses (THD Gatekeeper™ Delivery System, THD SpA, Correggio, Italy) were implanted under 3D-EUS control through a 5mm perianal incision at 1, 3, 5, 7, 9 and 11 o'clock in lithotomy position, and located in the upper-middle intersphincteric space of the anal canal, using a specifically designed system.
Eligibility Criteria
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Inclusion Criteria
* with at least 6 months of GI and/or soiling
* non-responding to conservative treatment and biofeedback.
Exclusion Criteria
* common Bristol score \> 4
* malignant diseases
* chronic diarrhoea
* inflammatory bowel disease
* acute anorectal disease
* rectal prolapse
* neurological disease,
* obstructive defecation syndrome
* low anterior resection syndrome,
* previous pelvic radiation,
* any anaesthetic contraindication
* St. Mark's score \> 12
* external anal sphincter lesion \> 30º.
18 Years
ALL
No
Sponsors
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Hospital Mutua de Terrassa
OTHER
Responsible Party
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Arantxa Muñoz-Duyos
Clinical Chief of General and Digestive Surgery
Other Identifiers
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P21/0001
Identifier Type: -
Identifier Source: org_study_id
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