Postoperative IleusPIDuSANCT02329912
Postoperative Ileus: Duration and Severity Assessment With the SmartPill®
A study testing SmartPill in people with Postoperative Ileus, run by University Hospital, Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- SmartPill
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Surgery, University of Bonn
Bonn, 53127
Tim Vilz, MD, 0049 228 287 15109, tim.vilz@ukb.uni-bonn.de
Sven Wehner, PhD, 0049 228 287 11007, sven.wehner@ukb.uni-bonn.de
About this study
Official title: The SmartPill® as an Objective Parameter to Evaluate Severity and Duration of Postoperative Ileus
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.
Read more
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.
Read the 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.
- Conditions
- Postoperative Ileus
- Being tested
- SmartPill
- Keywords
- postoperative ileus, SmartPill, gastrointestinal transit, prokinetic drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartPillDevice
Application of the SmartPill at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients after abdominal surgery | Experimental | SmartPill application after abdominal surgery Receives: Device: SmartPill |
| Patients after extraabdominal surgery | Sham comparator | SmartPill after extraabdominal surgery Receives: Device: SmartPill |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADEs / SADEs in Patients after surgery
Number of participants with ADEs / SADEs in Patients after surgery
Measured: 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
Analysis of pH changes measured by the SmartPill during gastrointestinal passage
Measured: 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
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)
Measured: 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
Variation of intraluminal pressure and peristaltic waves (mmHg) measured by the SmartPill before and after intravenous application of prokinetic drugs
Measured: 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
Variation of intraluminal pressure and peristaltic waves (mmHg) measured by the SmartPill before, during, and one hour after physiotherapy
Measured: 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
Analysis of pressure changes (mmHg) measured by the SmartPill during gastrointestinal passage
Measured: Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days
Analysis of temperature measured by the SmartPill during gastrointestinal passage
Analysis of temperature changes (°C) measured by the SmartPill during gastrointestinal passage
Measured: Participants will be followed from first postoperative day until excretion of the SmartPill, an expected average of 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bonn
- Responsible party
- Principal investigator, Dr. med. Tim Vilz, University Hospital, Bonn
- Investigators
- Tim O. Vilz, MD, Study director, Department of Surgery, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329912
- Sponsor's protocol ID
- CHI-201202
- Other IDs
- O-112.0055
- Acronym
- PIDuSA
- Status last verified
- Dec 2015
- First submitted
- 1 Dec 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tran K, Brun R, Kuo B. Evaluation of regional and whole gut motility using the wireless motility capsule: relevance in clinical practice. Ther Adv Gastroenterol. 2012 Jul;5(4):249-60. doi: 10.1177/1756283X12437874.
PubMed 22778790Storch 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.
PubMed 16644461Vilz 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.
PubMed 27401360
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SmartPill® as an Objective Parameter to Evaluate Severity and Duration of Postoperative Ileus
- ClinicalTrials.gov ID
- NCT02329912
- Acronym / sponsor ID
- PIDuSA / CHI-201202
- Conditions
- Postoperative Ileus
- Keywords
- postoperative ileus, SmartPill, gastrointestinal transit, prokinetic drugs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- University of Bonn
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients after abdominal surgery | Experimental | Device: SmartPillSmartPill application after abdominal surgery |
| Patients after extraabdominal surgery | Sham comparator | Device: SmartPillSmartPill after extraabdominal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- allergy against the device or components of the device
- existing or planned pregnancy
- emergency surgery
- NSAID (non steroidal antiinflammatory drugs) induced enteropathy
- BMI > 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartPillApplication of the SmartPill at the end of surgery | Device | Patients after abdominal surgery, Patients after extraabdominal surgery |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 22778790Tran K, Brun R, Kuo B. Evaluation of regional and whole gut motility using the wireless motility capsule: relevance in clinical practice. Ther Adv Gastroenterol. 2012 Jul;5(4):249-60. doi: 10.1177/1756283X12437874.
- Background: PubMed 16644461Storch 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.
- Derived from this study: PubMed 27401360Vilz 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.
Related trials for Postoperative Ileus
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim O. Vilz, MD study director
Department of Surgery, University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartPill in people with Postoperative Ileus, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tim O. Vilz, MD (0049 228 287 15109, tim.vilz@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329912, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.