Trial reportInternational journal of colorectal disease2017
Ultrasonographic evidence of Gatekeeper™ prosthesis migration in patients treated for faecal incontinence: a case series.
Trial report in International journal of colorectal disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- A systematic review of the clinical treatment of patients with fecal incontinence by artificial anal sphincter.Techniques in coloproctology · 2024Pooled it
- Clinical effectiveness and safety of self-expandable implantable bulking agents for faecal incontinence: a systematic review.BMC gastroenterology · 2022Pooled it
- Tools for fecal incontinence assessment: lessons for inflammatory bowel disease trials based on a systematic review.United European gastroenterology journal · 2020Pooled it
- Gatekeeper™ Prostheses Implants in the Anal Canal for Gas Incontinence and Soiling: Long-Term Follow-Up.Journal of clinical medicine · 2024Article
- Endosonographic monitoring of SphinkeeperUpdates in surgery · 2024Observational
- An evaluation of the long-term effectiveness of Gatekeeper™ intersphincteric implants for passive faecal incontinence.Techniques in coloproctology · 2022Article
- Critical appraisal of international guidelines for the management of fecal incontinence in adults: is it possible to define what to do in different clinical scenarios?Techniques in coloproctology · 2022Review
- Efficacy of Sphinkeeper™ implant in treating faecal incontinence.The British journal of surgery · 2020Observational
- Sphinkeeper™ for faecal incontinence: a preliminary report.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2020Article
- Outcomes of GatekeeperTechniques in coloproctology · 2017Observational
Corrections and comments
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFaecal incontinence (FI) is both a medical and social problem, with an underestimated incidence. For patients with internal anal sphincter damage, implantation of biomaterial in the anal canal is a recognised treatment option. One such material, Gatekeeper™, has previously shown promising short- and medium-term results without any major complications, including displacement. The main aim of the present study is to assess the degree to which displacement of Gatekeeper prostheses may occur and to determine whether this is associated with patient outcomes.
methodsSeven patients (six females) with a mean age of 55.6 years [50.5-57.2] and a mean FI duration of 6 ± 2 years were prospectively enrolled in the study. Each subject was anaesthetised and underwent implantation of six prostheses in the intersphincteric region, guided by endoanal 3D ultrasound (3D-EAU). Follow-up was performed at post-interventional months 1, 3, and 12 (median 12 ± 4 months), during which data were obtained from a defaecation diary, Wexner scale assessment, anorectal manometry (ARM), 3D-EAU, and a health status and quality of life questionnaire (FIQL).
resultsAt 3-month follow-up, 3D-EAU revealed displacement of 24/42 prostheses in 5/7 patients. Of these, 15 had migrated to the lower portion and 9 to the upper portion of the anal canal and rectum. Despite this migration, treatment was considered successful in 3/7 patients. In one patient, it was necessary to remove a prosthesis due to spontaneous extrusion.
conclusionsWe have shown that displacement of the Gatekeeper™ prosthesis occurs, but is not associated with poorer clinical outcomes.
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