Acceptability, effectiveness and safety of a Renew® anal insert in patients who have undergone restorative proctocolectomy with ileal pouch anal anastomosis
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Accepted version
Author(s)
Type
Journal Article
Abstract
Introduction
Restorative proctocolectomy has gained acceptance in the surgical management of medically refractive ulcerative colitis and cancer prevention in familial adenomatous polyposis. Incontinence following restorative proctocolectomy occurs in up to 25% of patients overnight. The Renew® insert is an inert single‐use device which acts as an anal plug. The aim of this study was to assess the acceptability, effectiveness and safety of the Renew® insert in patients who have undergone restorative proctocolectomy. The device has yet to be assessed in patients who have undergone restorative proctocolectomy.
Method
This was a prospective study exploring the acceptability, effectiveness and safety of the Renew® insert in improving incontinence in patients who had undergone restorative proctocolectomy. A total of 15 patients with incontinence were asked to use the Renew® insert for 14 days following their standard care. The Incontinence Questionnaire–Bowels was used pre‐ and posttreatment to assess response and patients were asked to report the perceived acceptability, effectiveness and safety of the device at the end of the trial.
Results
The device was acceptable to 8/15 (53%) of patients and was effective in 6/15 (40%). Only 2/15 (13%) of patients raised any safety concerns, and these were minor. The device was associated with a significant reduction in night seepage (P = 0.034).
Conclusion
In a small study, the Renew® insert can be both acceptable and effective and is also associated with few safety concerns. It is also associated with significant reductions in night‐time seepage.
Restorative proctocolectomy has gained acceptance in the surgical management of medically refractive ulcerative colitis and cancer prevention in familial adenomatous polyposis. Incontinence following restorative proctocolectomy occurs in up to 25% of patients overnight. The Renew® insert is an inert single‐use device which acts as an anal plug. The aim of this study was to assess the acceptability, effectiveness and safety of the Renew® insert in patients who have undergone restorative proctocolectomy. The device has yet to be assessed in patients who have undergone restorative proctocolectomy.
Method
This was a prospective study exploring the acceptability, effectiveness and safety of the Renew® insert in improving incontinence in patients who had undergone restorative proctocolectomy. A total of 15 patients with incontinence were asked to use the Renew® insert for 14 days following their standard care. The Incontinence Questionnaire–Bowels was used pre‐ and posttreatment to assess response and patients were asked to report the perceived acceptability, effectiveness and safety of the device at the end of the trial.
Results
The device was acceptable to 8/15 (53%) of patients and was effective in 6/15 (40%). Only 2/15 (13%) of patients raised any safety concerns, and these were minor. The device was associated with a significant reduction in night seepage (P = 0.034).
Conclusion
In a small study, the Renew® insert can be both acceptable and effective and is also associated with few safety concerns. It is also associated with significant reductions in night‐time seepage.
Date Issued
2019-01-01
Date Acceptance
2018-09-03
Citation
Colorectal Disease, 2019, 21 (1), pp.73-78
ISSN
1462-8910
Publisher
Wiley
Start Page
73
End Page
78
Journal / Book Title
Colorectal Disease
Volume
21
Issue
1
Copyright Statement
© 2018 The Association of Coloproctology of Great Britain and Ireland. This is the accepted version of the following article: Segal, J. P., Leo, C. A., Hodgkinson, J. D., Cavazzoni, E. , Bradshaw, E. , Lung, P. F., Ilangovan, R. , Vaizey, C. J., Faiz, O. D., Hart, A. L. and Clark, S. K. (2018), Acceptability, effectiveness and safety of a Renew® anal insert in patients who have undergone restorative proctocolectomy with ileal pouch–anal anastomosis. Colorectal Dis. . doi:10.1111/codi.14422, which has been published in final form at https://dx.doi.org/10.1111/codi.14422
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/30218632
Subjects
IPAA
Faecal Incontinence
Ileoanal pouch
Renew® Anopress
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2018-09-15