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Defecatory Function Studies Using the Fecobionics Device Are Repeatable

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A Concise Commentary to this article was published on 07 March 2023

Abstract

Background

Only limited data exist on repeatability of anorectal studies with the established physiological and clinical technologies for assessment of anorectal function. Fecobionics is a new multi-sensor simulated feces that provide data by integrating elements from current tests.

Aims

To study repeatability of anorectal data obtained with the Fecobionics device.

Methods

We assessed the database of Fecobionics studies to determine how many repeated studies were done. From a total of 260 Fecobionics studies, 19 subjects with repeated studies using approximately the same protocol and prototype were identified. Key pressure and bending parameters were assessed and the repeatability analyzed using Bland Altman plots. Furthermore, the inter- and intra-individual coefficient of variation (CV) were computed.

Results

Fifteen subjects (5F/10 M) with repeated studies were normal subjects, three were patients with fecal incontinence and one subject suffered from chronic constipation. The main analysis was conducted on the cohort of normal subjects. The bias for 11 parameters were within the confidence interval, whereas two were slightly outside. The interindividual CV was lowest for the bend angle (10.1–10.7) and between 16.3 and 51.6 for the pressure parameters. The intra-individual CVs were approximately half of the inter-individual CVs, spanning from 9.7 to 27.6.

Conclusion

All data from normal subjects were within previously defined normality. The Fecobionics data showed acceptable repeatability with bias within the confidence limits for almost all parameters. The intra-individual CV was much lower than the inter-individual CV. Dedicated large-scale studies are warranted to evaluate the influence of age, sex, and disease on repeatability as well as comparing between technologies.

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Funding

Research reported in this publication was supported by RCG grants #14106717 and #14112020, and HMRF project 6905522 (Hong Kong) and from the Office of The Director, National Institutes of Health of the National Institutes of Health under Award Number OT2ODO28203.

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Authors and Affiliations

  1. California Medical Innovations Institute, San Diego, CA, USA

    Kar Man Lo & Hans Gregersen

  2. Chongqing Engineering Research Center of Medical Electronics and Information Technology, Chongqing University of Posts and Telecommunications, Chongqing, China

    Daming Sun

  3. Department of Surgery, The Chinese University of Hong Kong, Shatin, Hong Kong

    Ssu-Chi Chen, Wing Wa Leung, Cherry Wong, Tony Mak, Simon Ng & Kaori Futaba

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  1. Kar Man Lo
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  2. Daming Sun
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  3. Ssu-Chi Chen
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  6. Tony Mak
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Contributions

HG and KML designed the study, obtained funding, and advised the experimental work during the study period. DS, SCC, KF, KML, and HG participated in the experiments. Data analysis was conducted by DS, KML, and HG and interpreted by all authors. HG and KML drafted the manuscript. All authors had access to the data, revised the manuscript and approved the final version for submission.

Corresponding author

Correspondence to Hans Gregersen.

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Conflict of interest

Gregersen has filed patent applications on the Fecobionics technology. No other conflicts of interest noted.

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A commentary on this article is available at https://doi.org/10.1007/s10620-023-07891-8.

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Lo, K.M., Sun, D., Chen, SC. et al. Defecatory Function Studies Using the Fecobionics Device Are Repeatable. Dig Dis Sci 68, 2501–2507 (2023). https://doi.org/10.1007/s10620-023-07889-2

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