Clinical Trial: Postoperative Ileus: Duration and Severity Assessment With the SmartPill®

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: The SmartPill® as an Objective Parameter to Evaluate Severity and Duration of Postoperative Ileus

Brief 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).