Observational studyTechniques in coloproctology2017
Outcomes of Gatekeeper
Observational study in Techniques in coloproctology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.
- 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
- Long-term outcome after SphinKeeper® surgery for treating fecal incontinence-who are good candidates?Langenbeck's archives of surgery · 2023Article
- 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
- Sphinkeeper Procedure for Treating Severe Faecal Incontinence-A Prospective Cohort Study.Journal of clinical medicine · 2021Article
- Surgical Treatment Alternatives to Sacral Neuromodulation for Fecal Incontinence: Injectables, Sphincter Repair, and Colostomy.Clinics in colon and rectal surgery · 2021Review
- Efficacy of Sphinkeeper™ implant in treating faecal incontinence.The British journal of surgery · 2020Observational
- Gatekeeper Improves Voluntary Contractility in Patients With Fecal Incontinence.Surgical innovation · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe implantation of Gatekeeper ™ (GK) represents a new option for the treatment of fecal incontinence (FI). The aim of this study was to analyze the postoperative morbidity associated with GK and to determine its clinical efficacy after at least 1 year of follow-up.
methodsThis was a multicenter, retrospective and longitudinal study of patients with FI who were treated with GK at our institutions between January 2010 and December 2015. Patients with FI without sphincter lesions or with sphincter injuries < 120° and with low anterior resection syndrome were included. Postoperative complications, long-term adverse effects and migration were recorded. FI severity was assessed using the Vaizey score. Patients were classified as responders or non-responders according to the improvement of the Vaizey score (≥ than 50 and < 50%, respectively) during the first 6 months after implantation.
resultsForty-nine consecutive patients treated with GK between 2010 and 2015 were included (11 males and 38 females, mean age 63.3 years, SD 13.5). No postoperative and long-term complications were observed. Prosthesis migration was observed in 51% of patients. Twenty-three patients (48%) were classified as responders and 25 (52%) as non-responders. The mean Vaizey score at baseline, 6, 12 months and last visit post-surgery in the responder group was, respectively, 13.3 (SD 3.8), 4.3 (SD 2.1), 4.2 (SD 3.6) and 5.7 (SD 5.3). Significant differences were observed between the mean baseline Vaizey score and the mean 6, 12 and last follow-up Vaizey score values (p < 0.001). In long-term follow-up (2.7 years (SD 1.1)), responders maintained an improvement of more than 50% of the baseline Vaizey score. In the non-responder group the mean number of migrated prostheses was higher than in the responder group (2.4 SD 2.5 vs. 1.0 SD 1.6; p = 0.040).
conclusionsGK is a safe and effective procedure in more than 50% of the patients for at least 1 year after the implantation.
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Registered trials
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.