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Postoperative Ileus: Duration and Severity Assessment With the SmartPill® (PIDuSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329912
Recruitment Status : Unknown
Verified December 2015 by Dr. med. Tim Vilz, University Hospital, Bonn.
Recruitment status was:  Recruiting
First Posted : January 1, 2015
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
University of Bonn
Information provided by (Responsible Party):
Dr. med. Tim Vilz, University Hospital, Bonn

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).
  • 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.


Condition or disease Intervention/treatment Phase
Postoperative Ileus Device: SmartPill Not Applicable

Detailed Description:

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. Instead, the quality of the existing clinical trials are just of low or moderate quality. The main reason for this is the lack of a valid surrogate marker to define the end of POI: Some trials used first flatus or first defecation as a marker for purposeful peristalsis and resolution of POI, others used the ability to consume solid food again or auscultation of bowel sounds. However it remains questionable whether these parameters are really able to demonstrate the severity or the end of POI.

Therefore POI research needs a reliable, patient and investigator independent parameter that is able to determine resolution of POI to improve the quality of future clinical trials.

A novel tool to examine gastrointestinal function is the SmartPill®. The capsule is able to measure pH value, temperature and intraluminal pressure after oral application, the data is sent to a transmitter located near the patient. Using those values, it is possible to analyse gastric emptying, length of small bowel, large bowel or whole gut passage and the smooth muscle contractility/peristalsis of the whole gastrointestinal tract. Therefore the SmartPill® would be an ideal, patient and investigator independent tool to investigate gastrointestinal function and transit time after visceral surgery.

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 lenght of POI and to examine whether the used prokinetic drugs and postoperative mobilization are able to influence peristaltic activity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The SmartPill® as an Objective Parameter to Evaluate Severity and Duration of Postoperative Ileus
Study Start Date : December 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Patients after abdominal surgery
SmartPill application after abdominal surgery
Device: SmartPill
Application of the SmartPill at the end of surgery

Sham Comparator: Patients after extraabdominal surgery
SmartPill after extraabdominal surgery
Device: SmartPill
Application of the SmartPill at the end of surgery




Primary Outcome Measures :
  1. ADEs / SADEs in Patients after surgery [ Time Frame: Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days ]
    Number of participants with ADEs / SADEs in Patients after surgery


Secondary Outcome Measures :
  1. Analysis of pH value measured by the SmartPill during gastrointestinal passage [ Time Frame: Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days ]
    Analysis of pH changes measured by the SmartPill during gastrointestinal passage

  2. Correlation between clinical signs of POI resolution and passage time of the SmartPill [ Time Frame: Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days ]
    Analysis of the correlation between clinical signs of targeted peristalsis (time until first defecation in combination with tolerance of solid food) and gastric emptying (hours), small bowel and large bowel transit time (hours)

  3. Peristaltic activity before and after application of prokinetics [ Time Frame: Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days ]
    Variation of intraluminal pressure and peristaltic waves (mmHg) measured by the SmartPill before and after intravenous application of prokinetic drugs

  4. Peristaltic activity before, during and after physiotherapy [ Time Frame: Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days ]
    Variation of intraluminal pressure and peristaltic waves (mmHg) measured by the SmartPill before, during, and one hour after physiotherapy

  5. Analysis of pressure measured by the SmartPill during gastrointestinal passage [ Time Frame: Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days ]
    Analysis of pressure changes (mmHg) measured by the SmartPill during gastrointestinal passage

  6. Analysis of temperature measured by the SmartPill during gastrointestinal passage [ Time Frame: Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days ]
    Analysis of temperature changes (°C) measured by the SmartPill during gastrointestinal passage



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • abdominal surgery or thoracic/periphery vascular surgery with an estimated operation time > 90 min and < 10 h
  • Age > 18 years
  • written informed consent
  • ASA score I - III
  • negative serum pregnancy test

Exclusion Criteria:

  • allergy against the device or components of the device
  • existing or planned pregnancy
  • emergency surgery
  • NSAID (non steroidal antiinflammatory drugs) induced enteropathy
  • BMI > 40
  • dysphagia
  • medical history of gastric bezoars
  • medication with proton pump inhibitor, H2-blockers or antacids
  • necessity of an MRI in the first two weeks after the operation
  • ASA score IV or higher
  • gastro-esophageal reflux ("Savary and Miller" III or IV)
  • anastomosis between esophagus and jejunum
  • fistula or stenosis of the GI tract which is not treated by the operation
  • active Crohn´s disease
  • Diverticulitis/severe diverticulosis, which is not treated during the operation
  • the following operations: all kind of organ transplantations, extended liver resections (extended right or left hemihepatectomy), very low rectum resection with or without a loop ileostoma, small bowel resection with end-to-end anastomosis, near total gastrectomy, transhiatal extended gastrectomy
  • patients undergoing abdominal surgery with an increased bleeding propensity (INR > 2, thrombocytes < 50 G/l...)
  • perioperative treatment with ciclosporin, tacrolimus, sirolimus, everolimus, methotrexate, Decortin > 15 mg/d, bevazicumab
  • no complete inspection for adhesions, fistulas etc. was possible during the operation
  • unexpected events during the operation (major bleeding with transfusion of 2 or more erythrocyte concentrates, hazardously anastomosis) mentioned by the surgeon

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329912


Contacts
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Contact: Tim O. Vilz, MD 0049 228 287 15109 tim.vilz@ukb.uni-bonn.de
Contact: Martin Coenen, MD 0049 228 287 16045 martin.coenen@ukb.uni-bonn.de

Locations
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Germany
Department of Surgery, University of Bonn Recruiting
Bonn, Germany, 53127
Contact: Tim Vilz, MD    0049 228 287 15109    tim.vilz@ukb.uni-bonn.de   
Contact: Sven Wehner, PhD    0049 228 287 11007    sven.wehner@ukb.uni-bonn.de   
Sponsors and Collaborators
University Hospital, Bonn
University of Bonn
Investigators
Layout table for investigator information
Study Director: Tim O. Vilz, MD Department of Surgery, University of Bonn
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. med. Tim Vilz, Deputy Head of the Surgical Study Center, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT02329912    
Other Study ID Numbers: CHI-201202
O-112.0055 ( Other Grant/Funding Number: BONFOR )
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015
Keywords provided by Dr. med. Tim Vilz, University Hospital, Bonn:
postoperative ileus
SmartPill
gastrointestinal transit
prokinetic drugs
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases