Observational studyThe British journal of surgery2016
Multicentre observational study of the Gatekeeper for faecal incontinence.
Observational study in The British journal of surgery, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03080753 (Treatment of Anal Incontinence Using Intersphincteric Implants), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Treatment of Anal Incontinence Using Intersphincteric Implants (SphinKeeper)
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 59 citations in OpenAlex.
- Clinical effectiveness and safety of self-expandable implantable bulking agents for faecal incontinence: a systematic review.BMC gastroenterology · 2022Pooled it
- Guideline for the diagnosis and treatment of Faecal Incontinence-A UEG/ESCP/ESNM/ESPCG collaboration.United European gastroenterology journal · 2022Guideline
- Tools for fecal incontinence assessment: lessons for inflammatory bowel disease trials based on a systematic review.United European gastroenterology journal · 2020Pooled it
- Cost-analysis and quality of life after laparoscopic and robotic ventral mesh rectopexy for posterior compartment prolapse: a randomized trial.Techniques in coloproctology · 2019Trial
- Ultrasonographic evidence of Gatekeeper™ prosthesis migration in patients treated for faecal incontinence: a case series.International journal of colorectal disease · 2017Trial
- 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
- Long-term outcome after SphinKeeper® surgery for treating fecal incontinence-who are good candidates?Langenbeck's archives of surgery · 2023Article
- Injection of aluminum potassium sulfate and tannic acid in the treatment of fecal incontinence: a single-center observational study.Annals of coloproctology · 2022Article
- 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
- Gatekeeper Improves Voluntary Contractility in Patients With Fecal Incontinence.Surgical innovation · 2019Article
- Outcomes of GatekeeperTechniques in coloproctology · 2017Observational
- Fecal incontinence - Challenges and solutions.World journal of gastroenterology · 2017Review
- Implantation of SphinKeeper(TM): a new artificial anal sphincter.Techniques in coloproctology · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation.
methodsPatients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow-up.
resultsFifty-four patients were implanted. After Gatekeeper implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required.
conclusionAnal implantation of the Gatekeeper in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1-year follow-up.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.