Endoscopy 2019; 51(01): 85-92
DOI: 10.1055/a-0632-1927
Original article
© Georg Thieme Verlag KG Stuttgart · New York

A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study

Kelly E. van Keulen
1  Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands
,
Helmut Neumann
2  Department of Gastroenterology and Hepatology, University of Mainz, Mainz, Germany
,
Jörn M. Schattenberg
2  Department of Gastroenterology and Hepatology, University of Mainz, Mainz, Germany
,
Aura A. J. van Esch
1  Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands
,
Wietske Kievit
3  Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands
,
Manon C. W. Spaander
4  Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, the Netherlands
,
Peter D. Siersema
1  Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands
› Author Affiliations
TRIAL REGISTRATION: Single-arm, international, multicenter study NCT03026075at clinicaltrials.gov
Further Information

Publication History

submitted 16 January 2018

accepted after revision 23 April 2018

Publication Date:
11 July 2018 (eFirst)

Abstract

Background The importance of high quality preprocedural bowel preparation is widely acknowledged, but suboptimal bowel cleansing still occurs in up to 20 % of all colonoscopy patients. The aim of this study was to evaluate the performance of a novel intraprocedural cleaning device for cleaning poorly prepared colons.

Methods This multicenter feasibility study included patients aged 18 – 75 years who were referred for colonoscopy. Intraprocedural cleaning was performed in patients after a limited preprocedural bowel preparation regimen (2 days of dietary restrictions and 2 × 10 mg bisacodyl). The primary outcome was the proportion of adequately prepared patients (Boston Bowel Preparation scale [BBPS] ≥ 2 in each segment) before and after segmental washing with the new device. Secondary outcomes included: cecal intubation rate, procedure time, system usability, patient satisfaction, and safety.

Results 47 patients (42.6 % male), with a median age of 61 years (interquartile range [IQR] 46 – 67 years), were included at three clinical sites. Cecal intubation was achieved in 46/47 patients (97.9 %). The cleaning device significantly improved the proportion of patients with adequate bowel cleansing (from 19.1 % to 97.9 %; P < 0.001) and median BBPS score (from 3.0 [IQR 0.0 – 5.0] to 9.0 [IQR 8.0 – 9.0]). Median cecal intubation time and total procedure time were 16.5 minutes (IQR 9.0−28.3) and 34.0 minutes (IQR 25.0 – 42.8), respectively. Physicians were satisfied with the ease of use of the device and it was well tolerated by patients. No severe adverse events occurred during the study period.

Conclusions This feasibility study suggests that the intraprocedural cleaning device appears to be safe and effective in cleaning poorly prepared colons to an adequate level, allowing a thorough colorectal examination.