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UEG Week Berlin 2025 Recordings Gut Guide online

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Introduction

Accurate diagnosis of Pelvic Floor Disorders (PFD) requires multiple tests, including balloon expulsion, anorectal manometry, and defecography. Current diagnostic approaches have significant limitations: they require multiple visits to specialized clinics, are conducted in non-private and often embarrassing environments, and use non-physiologic (lying) positions. As a result, they (a) provide fragmented, sometimes inaccurate, and difficult-to-integrate information, and (b) are inconvenient and distressing for patients, while time-consuming for providers and payers.

Aims & Methods

To develop a novel, comprehensive, accurate, all-in-one diagnostic system to replace current multi-test approaches.
We developed a disposable balloon and catheter system capable of simultaneously measuring rectal and anal pressures and anorectal angle. These physiological metrics are recorded during balloon expulsion in a physiologic seated position. Data are transmitted via Bluetooth to a nearby computer, enabling the test to be performed in a private toilet room. The system was tested for functionality, convenience, and safety, and compared with balloon expulsion (Mui Scientific) and high-resolution manometry (HRM, ManoScan™, Medtronic) in both lying and seated positions, using standardized protocols (London and IAPWG).

Results

The Ano-Rectal Diagnostic System (ARDiS) reliably measured rectal and anal pressures in both positions, with values comparable to standard HRM. ARDiS also enabled novel assessment of anorectal angle. These parameters were recorded simultaneously in real time during seated balloon expulsion. Data transmission to a nearby laptop or office computer was seamless. The procedure was well tolerated, with no reported side effects. Patients preferred the private, seated testing environment.

Conclusion

The ARDiS system enables comprehensive, accurate, and simultaneous assessment of anorectal function in one convenient session. Designed for both hospitals and outpatient clinics, ARDiS streamlines the diagnostic process, improves patient compliance, and supports accurate diagnosis and personalized management of PFD. It may fundamentally transform clinical practice by replacing multiple fragmented tests with a single integrated solution.

Disclosure

Glukhovsky & Melamud: Shares in ARDiS Medical Ltd.
Ringel: Scientific Advisory Board, ARDiS Medical Ltd

ALL-IN-ONE NOVEL DIAGNOSTIC SYSTEM FOR PELVIC FLOOR DISORDERS – RESULTS FROM FIRST IN HUMAN STUDY

Yaron Rudnicki 1, Yehuda Ringel 2

1 Meir Medical Center, Kefar Sava, Israel

2 Meir Medical Center, Tel Aviv University, Tel Aviv, Israel

Conference

UEG Week Berlin 2025

Topics

Colorectal

Submission format

Abstract

Session

LOWER GI (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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THREE-ARM RANDOMIZED CONTROLLED TRIAL OF ACETIC ACID–INDIGO CARMINE MIXTURE (AIM) CHROMOCOLONOSCOPY FOR ENHANCED DETECTION OF PROXIMAL COLONIC SERRATED LESIONS

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Introduction

Serrated lesions (SLs) in the proximal colon are increasingly recognized as important precursors to colorectal cancer (CRC), yet their detection remains challenging due to their flat morphology and subtle appearance. While chromoendoscopy using indigo carmine (IC) improves detection rates compared to white-light imaging (WLI), the utility of acetic acid-indigo carmine mixture (AIM)–based chromocolonoscopy remains unverified. This randomized controlled trial aimed to evaluate the efficacy of AIM compared to WLI and IC in detecting SLs in the proximal colon, with a focus on the impact of a second tandem examination.

Aims & Methods

In this multicenter, prospective, randomized controlled trial conducted at nine Japanese institutions, patients undergoing total colonoscopy were randomly assigned to three groups (WLI, IC, or AIM). All patients underwent a tandem examination of the proximal colon, defined as the region from the cecum to the hepatic flexure. The primary outcomes were the SL detection rate in the second observation (SDR2nd) and SL additional rate (SAR). Secondary outcomes included the detection and additional rates of other polys and factors contributing to SAR.

Results

A total of 1,319 patients were included in the per-protocol analysis. SDR2nd in the AIM group was significantly higher than that in the IC and WLI groups (14.0% vs. 7.9% vs. 2.7%, respectively). Similarly, ADR2nd was 24.7% in the AIM group, 22.2% in the IC group, and 10.5% in the WLI group. SAR was highest in the AIM group (69.3%), compared to 45.8% in IC and 22.4% in WLI. Multivariate logistic regression showed that AIM (OR 7.79, 95% CI: 3.76–17.08) and IC (OR 2.87, 95% CI: 1.37–6.28) were independently associated with improved SAR. GEE analysis indicated minimal interobserver variability. AIM also facilitated the detection of previously missed advanced SLs and sessile serrated polyposis syndrome (SPS), leading to changes in surveillance intervals.

Conclusion

AIM-based chromocolonoscopy significantly improves the detection of SLs in the proximal colon compared with IC and WLI. These findings support the incorporation of duplicate, contrast-enhanced examinations into routine colonoscopy practice and suggest AIM as a superior technique for detecting flat and mucus-covered SLs. Further studies are warranted to assess the long-term impact of improved SL detection on CRC incidence and mortality.