SmartPill® as an objective parameter for determination of severity and duration of postoperative ileus: study
Tim O Vilz1, Dimitrios Pantelis1, Philipp Lingohr1
1Department of Surgery, University of Bonn, Bonn, Germany.
Insights
This study assessed the safety and feasibility of the SmartPill® in patients after abdominal surgery to monitor postoperative ileus (POI). Findings will help establish objective parameters for POI assessment and treatment efficacy.
Area of Science:
- Gastroenterology
- Surgical Complications
- Medical Device Technology
Background:
- Postoperative ileus (POI) is a common complication following abdominal surgery (AS), lacking objective diagnostic parameters and effective treatments.
- Current clinical trials for POI are often limited by subjective assessments of severity and duration.
- The SmartPill®, a device measuring gastrointestinal (GI) parameters, offers potential for objective POI evaluation.
Purpose of the Study:
- To investigate the safety and feasibility of using the SmartPill® in patients immediately after abdominal surgery.
- To analyze the influence of prokinetics, laxatives, and physiotherapy on postoperative bowel contractility.
- To correlate SmartPill® data with clinical signs of bowel motility disorders for objective POI assessment.
Main Methods:
- The PIDuSA study is a prospective, single-center, open-label trial involving 55 patients undergoing AS and 10 patients undergoing extra-abdominal surgery.
- The primary objective is to assess the safety of the SmartPill® based on adverse device effects (ADE/SADE).
- Secondary objectives include analyzing postoperative intestinal activity and correlating SmartPill® data with clinical outcomes.
Main Results:
- The study is registered as a pre-results trial (NCT02329912).
- Specific results regarding safety, feasibility, and the influence of interventions are pending.
- The SmartPill®'s potential as an objective POI assessment tool is under investigation.
Conclusions:
- The SmartPill® may offer a novel, objective method for evaluating gastrointestinal transit and contractility post-surgery.
- Further research is needed to validate its use in clinical practice for POI management.
- This study aims to provide evidence for the SmartPill®'s utility in improving the quality of POI clinical trials.
Introduction:
Postoperative ileus (POI) is a frequent complication after abdominal surgery (AS). Until today, neither a prophylaxis nor an evidence-based therapy exists. This originates from the absence of objective parameters evaluating the severity and duration of POI resulting in clinical trials of modest quality. The SmartPill(®), a capsule which frequently measures pH value, temperature and intraluminal pressure after swallowing, offers an elegant option for analysing gastrointestinal (GI) transit times and smooth muscle activity in vivo. As the use in patients in the first months after AS is not covered by the marketing authorisation, we aim to investigate the safety and feasibility of the SmartPill(®) immediately after surgery. Additionally, we analyse the influence of prokinetics and laxatives as well as standardised physiotherapy on postoperative bowel contractility, as scientific evidence of its effects is still lacking.
Methods And Analysis:
The PIDuSA study is a prospective, single-centre, two-arm, open-label trial. The SmartPill(®) will be applied to 55 patients undergoing AS having a high risk for POI and 10 patients undergoing extra-abdominal surgery rarely developing POI. The primary objective is the safety of the SmartPill(®) in patients after surgery on the basis of adverse device effects/serious adverse device effects (ADE/SADE). The sample size suggests that events with a probability of 3% could be seen with a certainty of 80% for at least once in the sample. Secondary objective is the analysis of postoperative intestinal activity in the GI tract in both groups. Furthermore, clinical signs of bowel motility disorders will be correlated to the data measured by the SmartPill(®) to evaluate its significance as an objective parameter for assessing POI severity. Additionally, effects of prokinetics, laxatives and physiotherapy on postoperative peristaltic activity recorded by the SmartPill(®) will be analysed.
Ethics And Dissemination:
The protocol was approved by the federal authority (94.1.05-5660-8976) and the local ethics committee (092/14-MPG). Findings will be disseminated through publications and conference presentations.
Trial Registration Number:
NCT02329912; Pre-results.
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