Non-invasive assessment of bowel function after abdominal surgery
Research type
Research Study
Full title
Non-invasive assessment of bowel function after abdominal surgery – an early feasibility study
IRAS ID
311080
Contact name
Mikolaj Kowal
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Introduction:
Post-operative ileus (POI) is characterised by a delayed return of bowel function after surgery. It leads to greater post-operative complications, increases hospital stay and increases costs for healthcare systems. We aim to explore the possible role of electronic stethoscope technology and point-of-care ultrasonography to monitor post-operative bowel function using an objective non-invasive assessment.Methods:
A single-arm, prospective, development study (IDEAL Stage 2a) will be performed. 30 patients undergoing intestinal surgery will be recruited to the study involving a non-invasive assessment of bowel function pre-operatively and on post-operative days (POD) 1, 3 and 5. Bowel function will be assessed via recordings of bowel sounds using an electronic stethoscope device and dynamic image capture using point-of-care ultrasound. Primary feasibility outcomes include: i) completeness of study assessment protocols as planned; and ii) feasibility of applying existing analysis algorithms to dataset. Secondary clinical outcomes include: i) time to first passage of flatus, ii) time to first passage of stool; iii) time to first tolerance of oral diet, and iv) time to gastrointestinal recovery using a validated tool (GI-2). Up to 10 patients will be invited for an optional qualitative sub-study which will explore patients’ experiences and perspectives of the study assessments.Discussion:
Novel technologies with validated analytical tools could allow us to improve the way we assess bowel function after surgery, leading to improved patient care, reduced costs and a greater capacity to deliver surgical services in the setting of rapidly increasing demand. The results of this study will explore the use of this technology for the first time in a clinical environment, as well as assessing patients’ experiences of the study assessments in preparations for a future trial of clinical efficacy. The results will also inform future efforts to explore these technologies as a possible tool to support future research of GI function.REC name
North East - York Research Ethics Committee
REC reference
22/NE/0128
Date of REC Opinion
16 Aug 2022
REC opinion
Favourable Opinion