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01-12-2017 | Original Article

Outcomes of Gatekeeper^TM prosthesis implantation for the treatment of fecal incontinence: a multicenter observational study

Authors: Loris Trenti, Sebastiano Biondo, Fernando Noguerales, Jesus Nomdedeu, Alba Coret, Roland Scherer, Domenico Fraccalvieri, Riccardo Frago, Esther Kreisler

Published in: Techniques in Coloproctology | Issue 12/2017

Abstract

Background

The 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.

Methods

This 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.

Results

Forty-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).

Conclusions

GK 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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Title: Outcomes of GatekeeperTM prosthesis implantation for the treatment of fecal incontinence: a multicenter observational study
Authors: Loris Trenti
Sebastiano Biondo
Fernando Noguerales
Jesus Nomdedeu
Alba Coret
Roland Scherer
Domenico Fraccalvieri
Riccardo Frago
Esther Kreisler
Publication date: 01-12-2017
Publisher: Springer International Publishing
Published in: Techniques in Coloproctology / Issue 12/2017
Print ISSN: 1123-6337
Electronic ISSN: 1128-045X
DOI: https://doi.org/10.1007/s10151-017-1723-8

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Outcomes of Gatekeeper^TM prosthesis implantation for the treatment of fecal incontinence: a multicenter observational study

Abstract

Background

Methods

Results

Conclusions

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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