NCT02329912

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

December 1, 2014

Last Update Submit

December 1, 2015

Conditions

Postoperative Ileus

Keywords

postoperative ileusSmartPillgastrointestinal transitprokinetic drugs

Outcome Measures

Primary Outcomes (1)

  • ADEs / SADEs in Patients after surgery

    Number of participants with ADEs / SADEs in Patients after surgery

    Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days

Secondary Outcomes (6)

  • Analysis of pH value measured by the SmartPill during gastrointestinal passage

    Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days

  • Correlation between clinical signs of POI resolution and passage time of the SmartPill

    Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days

  • Peristaltic activity before and after application of prokinetics

    Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days

  • Peristaltic activity before, during and after physiotherapy

    Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days

  • Analysis of pressure measured by the SmartPill during gastrointestinal passage

    Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days

  • +1 more secondary outcomes

Study Arms (2)

Patients after abdominal surgery

EXPERIMENTAL

SmartPill application after abdominal surgery

Device: SmartPill

Patients after extraabdominal surgery

SHAM COMPARATOR

SmartPill after extraabdominal surgery

Device: SmartPill

Interventions

SmartPillDEVICE

Application of the SmartPill at the end of surgery

Patients after abdominal surgeryPatients after extraabdominal surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, University of Bonn

Bonn, 53127, Germany

RECRUITING

Related Publications (3)

  • Tran K, Brun R, Kuo B. Evaluation of regional and whole gut motility using the wireless motility capsule: relevance in clinical practice. Therap Adv Gastroenterol. 2012 Jul;5(4):249-60. doi: 10.1177/1756283X12437874.

    PMID: 22778790BACKGROUND

  • Storch I, Barkin JS. Contraindications to capsule endoscopy: do any still exist? Gastrointest Endosc Clin N Am. 2006 Apr;16(2):329-36. doi: 10.1016/j.giec.2006.01.017.

    PMID: 16644461BACKGROUND

  • Vilz TO, Pantelis D, Lingohr P, Fimmers R, Esmann A, Randau T, Kalff JC, Coenen M, Wehner S. SmartPill(R) 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). BMJ Open. 2016 Jul 8;6(7):e011014. doi: 10.1136/bmjopen-2015-011014.

    PMID: 27401360DERIVED

Study Officials

  • Tim O. Vilz, MD

    Department of Surgery, University of Bonn

    STUDY DIRECTOR

Central Study Contacts

Tim O. Vilz, MD

CONTACT

0049 228 287 15109tim.vilz@ukb.uni-bonn.de

Martin Coenen, MD

CONTACT

0049 228 287 16045martin.coenen@ukb.uni-bonn.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head of the Surgical Study Center

Study Record Dates

First Submitted

December 1, 2014

First Posted

January 1, 2015

Study Start

December 1, 2014

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

DE(1)