Validation of body surface colonic mapping against high resolution colonic manometry: a novel non-invasive tool for evaluation of colonic motility

Sean HB Seo, Cameron I Wells, Tully Dickson,David Rowbotham, Armen Gharibans,Stefan Calder, Ian Bissett,Greg O’Grady,Jonathan C Erickson

medrxiv(2023)

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Abstract
Abnormal cyclic motor pattern (CMP) activity is implicated in colonic dysfunction, but the only tool to evaluate CMP activity, high-resolution colonic manometry (HRCM), remains expensive and not widely accessible. This study aimed to validate body surface colonic mapping (BSCM) through direct correlation with HRCM. Synchronous meal-test recordings were performed in asymptomatic participants with intact colons. A signal processing method for BSCM was developed to detect CMPs. Quantitative temporal analysis was performed comparing the meal responses and motility indices (MI). Spatial heat maps were also compared. Post-study questionnaire evaluated participants’ preference and comfort/distress experienced from either test. 11 participants were recruited and 7 had successful synchronous recordings (5 females/2 males; median age: 50 years [range: 38-63]). The best-correlating MI temporal analyses achieved a high degree of agreement (median Pearson correlation coefficient ( R p ) value: 0.69; range: 0.47 - 0.77). HRCM and BSCM meal response start and end times ( R p = 0.998 and 0.83; both p < 0.05) and durations ( R p = 0.85; p = 0.03) were similar. Heat maps demonstrated good spatial agreement. BSCM is the first non-invasive method to be validated by demonstrating a direct spatio-temporal correlation to manometry in evaluating colonic motility. ### Competing Interest Statement Greg O'Grady, Stefan Calder, Armen Gharibans and Jonathan Erickson are shareholders of Alimetry Ltd and hold intellectual property in the field of noninvasive gastric mapping. No commercial financial support was received for this study. The other authors have no conflict of interest to declare. ### Funding Statement This project was financially supported by CSSANZ with a Foundation Grant and New Zealand Health Research Council. Sean Ho Beom Seo is a recipient of the New Zealand Research Scholarship from RACS. Jonathan Erickson was supported by a Washington and Lee University Lenfest Sabbatical Fellowship. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical approval was obtained from Auckland Health Research Ethics Committee (AHREC); AH1287. This study was conducted in accordance with the ethical principles outlined in the Helsinki Declaration. All participants provided informed consent which included the use of non-identifying photographs in publication of the study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data generated in this work will be made available upon reasonable request.
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