title: SmartPill® as an objective parameter for determination of severity and duration of postoperative ileus: study protocol of a prospective, two-arm, open-label trial (the PIDuSA study).
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02329912; Pre-results.
authors.affiliation: Department of Surgery, University of Bonn, Bonn, Germany.
authors.forename: Tim O
authors.initials: TO
authors.lastname: Vilz
authors.affiliation: Department of Surgery, University of Bonn, Bonn, Germany.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Pantelis
authors.affiliation: Department of Surgery, University of Bonn, Bonn, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Lingohr
authors.affiliation: Clinical Study Core Unit, Study Center Bonn (SZB), University of Bonn, Bonn, Germany Institute of Medical Biometrics, Informatics and Epidemiology, Study Center Bonn, University of Bonn, Bonn, Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Fimmers
authors.affiliation: Department of Surgery, University of Bonn, Bonn, Germany.
authors.forename: Anke
authors.initials: A
authors.lastname: Esmann
authors.affiliation: Department of Orthopedics and Trauma Surgery, University of Bonn, Bonn, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Randau
authors.affiliation: Department of Surgery, University of Bonn, Bonn, Germany.
authors.forename: Jörg C
authors.initials: JC
authors.lastname: Kalff
authors.affiliation: Clinical Study Core Unit, Study Center Bonn (SZB), University of Bonn, Bonn, Germany Institute of Clinical Chemistry and Clinical Pharmacology, University of Bonn, Bonn, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Coenen
authors.affiliation: Department of Surgery, University of Bonn, Bonn, Germany.
authors.forename: Sven
authors.initials: S
authors.lastname: Wehner
mesh_terms: D004864:Equipment and Supplies; D005240:Feasibility Studies; D005772:Gastrointestinal Transit; D006801:Humans; D006863:Hydrogen-Ion Concentration; D045823:Ileus / Q000175:diagnosis* / Q000503:physiopathology; D061214:Patient Safety; D011183:Postoperative Complications / Q000175:diagnosis* / Q000503:physiopathology; D011312:Pressure; D011446:Prospective Studies; D012720:Severity of Illness Index; D013514:Surgical Procedures, Operative; D013696:Temperature; D013997:Time Factors; D059015:Wireless Technology / Q000295:instrumentation
keywords: SmartPill®; physiotherapy; postoperative ileus; prokinetic substances; safety; wireless motility capsule