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Postoperative Ileus: Duration and Severity Assessment With the SmartPill®

NCT02329912 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2015-12-02

No results posted yet for this study

Summary

Postoperative ileus (POI) is a frequent complication after abdominal surgery leading to nausea, vomiting and infectious complications. Bowel dysmotility can last for days and necessitates parenteral nutrition resulting in an prolonged hospital stay and a high economic burden.

Until now there is no evidence based therapy of manifest POI because of missing valid surrogate markers demonstrating the severity and resolution of POI.

A novel tool to examine gastrointestinal function is the SmartPill®. By measuring pH value, temperature and intraluminal pressure the capsule is able to analyse gastric emptying, small bowel transit, large bowel transit and peristaltic activity.

Unfortunately the use of the SmartPill® is not allowed in the first three months after abdominal surgery. Therefore a trial is needed to investigate the behaviour of the SmartPill® during its passage through the human gastrointestinal tract immediately after surgery.

The primary endpoint is

\- to investigate the safety of the SmartPill® in patients after abdominal surgery.

The secondary endpoints are:

* is the SmartPill® able to detect the gastrointestinal transit and the peristaltic activity followed by abdominal surgery compared with patients which underwent thoracic/vascular surgery.
* is it possible to correlate the measured parameters (delayed gastrointestinal transit, lack of peristalsis) with the clinical signs of POI (nausea, vomiting, prolonged duration until first postoperative defecation).
* is the detected peristaltic activity influenced by intravenous applicated prokinetic drugs
* is the detected peristaltic activity influenced by physiotherapy

Using those endpoints the investigators hope to demonstrate the safety of the SmartPill® after abdominal surgery, to evaluate its ability to analyse severity and length of POI and to examine whether the used prokinetic drugs and postoperative mobilization are able to influence peristaltic activity.

Conditions

  • Postoperative Ileus

Interventions

DEVICE

SmartPill

Application of the SmartPill at the end of surgery

Sponsors & Collaborators

  • University of Bonn

    collaborator OTHER

  • University Hospital, Bonn

    lead OTHER

Principal Investigators

  • Tim O. Vilz, MD · Department of Surgery, University of Bonn

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-03-31
Completion
2016-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02329912 on ClinicalTrials.gov