Postoperative IleusANTERO-5NCT04100265
ANTERO-5: Gastric Motility in Postoperative Ileus
A study testing Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System) and Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System) in people with Postoperative Ileus, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A monocenter, non-randomized interventional investigation in 3 panels of adult patients undergoing elective colorectal surgery who are at risk to develop postoperative ileus. The feasibility to use the VIPUN Gastric Monitoring System prototype 0.3 will be explored in this population for the first time. 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?
- Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System) and Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Oct 2019to 21 Jan 2021
- 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
- Signed Informed Consent
- At least 18 years old
- BMI between and including 18 and 30
- Understand and able to read Dutch
- Planned to undergo elective colorectal surgery
Who cannot join
- Known history of documented gastroparesis
- Known history of functional dyspepsia
- Known / suspected current use of illicit drugs
- Known psychiatric or neurological illness
- Any prior gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
- Known history of heart or vascular diseases like irregular heartbeats, angina or heart attack
Show all 12Show fewer
- Nasopharyngeal surgery in the last 30 days
- Suspected basal skull fracture or severe maxillofacial trauma
- Known history of thermal or chemical injury to upper respiratory tract or esophagus
- Current esophageal or nasopharyngeal obstruction
- Known coagulopathy
- Known esophageal varices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ANTERO-5: A Clinical Investigation of Gastric Motility in Adult Patients at Risk to Develop Postoperative Ileus Following Colorectal Surgery
A monocenter, non-randomized interventional investigation in 3 panels of adult patients undergoing elective colorectal surgery who are at risk to develop postoperative ileus.
The feasibility to use the VIPUN Gastric Monitoring System prototype 0.3 will be explored in this population for the first time.
- Conditions
- Postoperative Ileus
- Being tested
- Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System), Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)Device
Also called VIPUN Gastric Monitoring System prototype 0.3
The VIPUN Gastric Monitoring System prototype 0.3 comprises a nasogastric balloon catheter which is connected to an extracorporeal pressure sensor and data acquisition system. The device is placed during surgery.
Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)Device
Also called VIPUN Gastric Monitoring System prototype 0.3
The VIPUN Gastric Monitoring System prototype 0.3 comprises a nasogastric balloon catheter which is connected to an extracorporeal pressure sensor and data acquisition system. The device is placed upon the manifestation of clinical signs of postoperative ileus.
| Study group | Role | What they receive |
|---|---|---|
| Panel 1 - High risk for postoperative ileus | Experimental | Intervention in patients at high risk to develop prolonged postoperative ileus. Monitoring postoperative gastric motility for 2 consecutive days in patients who require preventive placement of a nasogastric feeding tube due to a high risk to develop postoperative ileus. Allowing to explore associations between gastric motility and general clinical evolution. Receives: Device: Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System) |
| Panel 2 - Postoperative ileus arm with investigational device | Experimental | Intervention in a population of patients with clinical signs of postoperative ileus, requiring a nasogastric feeding tube for symptom relief. The investigational medical device will be applied. Allowing to explore the association of gastric motility and clinical signs of postoperative ileus in an enriched population with true postoperative ileus. Receives: Device: Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System) |
| Panel 3 - Postoperative ileus arm with standard of care | No intervention | Standard of care control group of patients with clinical signs of postoperative ileus requiring a standard nasogastric feeding tube for symptom relief. Symptoms will be surveyed as control group to assess safety and tolerability of the investigational medical device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (composite endpoint)
Composite endpoint comprising: procedural success (absence of protocol deviations with regard to motility measurement), tolerability of the device (non-validated questionnaire on nasopharyngeal discomfort and the incidence of intolerance resulting in early removal of the investigational device) and device-related safety (incidence of adverse device effects related to the use of the device).
Measured: Day 1 - Day 14
Secondary outcomes (8)
Gastric motility
Long term motility index
Measured: Day 1 until termination motility recording (maximum 48 hours)
Evolution postoperative ileus - staff reported
Incidence of markers of resolution of postoperative ileus (first flatus, bowel sounds, bowel movements, solid food tolerance)
Measured: Day 1 until completion study procedures (maximum 14 days).
In hospital quality of life (EQ-5D-3L questionnaire)
EQ-5D-3L questionnaire consists of 2 pages: EQ-5D descriptive system and an EQ visual analogue scale (EQ VAS).
EQ-5D-3L (not an acronym) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The five dimensions can be combined into a 5-digit number that describes the patient's health state. EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Measured: Day 1 until completion study procedures (maximum 14 days)
Device performance
Incidence of device deficiencies
Measured: Day 1 until removal of device, no later than Day 14
Nausea severity
Patient reported severity of nausea (100 mm visual analogue scale ranging from Absent to Worst possible)
Measured: Day 1 until completion study procedures (maximum 14 days)
Abdominal bloating severity
Patient reported severity of abdominal bloating (100 mm visual analogue scale ranging from Absent to Worst possible)
Measured: Day 1 until completion study procedures (maximum 14 days)
Abdominal pain severity
Patient reported severity of abdominal pain (100 mm visual analogue scale ranging from Absent to Worst possible)
Measured: Day 1 until completion study procedures (maximum 14 days)
Abdominal discomfort severity
Patient reported severity of abdominal discomfort (100 mm visual analogue scale ranging from Absent to Worst possible)
Measured: Day 1 until completion study procedures (maximum 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start16 Oct 2019
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Why it stopped: Inadequate recruitment due to COVID-19 restrictions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized investigation in three panels with different eligibility criteria and study procedures. The target population in each arm consists of 10 'completers'. Completers are defined as: Panel 1: A successful gastric motility recording of at least 6 hours Panel 2: Patients who develop POI (estimated to be 10% of enrolled subjects) and in who gastric motility was recorded successfully for at least 6 hours Panel 3: Patients who develop POI, who completed questionnaires for at least 2 days (with a questionnaire completion rate ≥50%).
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100265
- Sponsor's protocol ID
- S63029
- Acronym
- ANTERO-5
- Status last verified
- Nov 2019
- First submitted
- 11 Sep 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANTERO-5: A Clinical Investigation of Gastric Motility in Adult Patients at Risk to Develop Postoperative Ileus Following Colorectal Surgery
- ClinicalTrials.gov ID
- NCT04100265
- Acronym / sponsor ID
- ANTERO-5 / S63029
- Conditions
- Postoperative Ileus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment due to COVID-19 restrictions.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 24 Sep 2019 (actual)
- 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.
A monocenter, non-randomized interventional investigation in 3 panels of adult patients undergoing elective colorectal surgery who are at risk to develop postoperative ileus.
The feasibility to use the VIPUN Gastric Monitoring System prototype 0.3 will be explored in this population for the first time.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Non-randomized investigation in three panels with different eligibility criteria and study procedures. The target population in each arm consists of 10 'completers'. Completers are defined as: Panel 1: A successful gastric motility recording of at least 6 hours Panel 2: Patients who develop POI (estimated to be 10% of enrolled subjects) and in who gastric motility was recorded successfully for at least 6 hours Panel 3: Patients who develop POI, who completed questionnaires for at least 2 days (with a questionnaire completion rate ≥50%).
| Arm | Type | Receives |
|---|---|---|
| Panel 1 - High risk for postoperative ileus | Experimental | Device: Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)Intervention in patients at high risk to develop prolonged postoperative ileus. Monitoring postoperative gastric motility for 2 consecutive days in patients who require preventive placement of a nasogastric feeding tube due to a high risk to develop postoperative ileus. Allowing to explore associations between gastric motility and general clinical evolution. |
| Panel 2 - Postoperative ileus arm with investigational device | Experimental | Device: Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)Intervention in a population of patients with clinical signs of postoperative ileus, requiring a nasogastric feeding tube for symptom relief. The investigational medical device will be applied. Allowing to explore the association of gastric motility and clinical signs of postoperative ileus in an enriched population with true postoperative ileus. |
| Panel 3 - Postoperative ileus arm with standard of care | No intervention | –Standard of care control group of patients with clinical signs of postoperative ileus requiring a standard nasogastric feeding tube for symptom relief. Symptoms will be surveyed as control group to assess safety and tolerability of the investigational medical device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Informed Consent
- At least 18 years old
- BMI between and including 18 and 30
- Understand and able to read Dutch
- Planned to undergo elective colorectal surgery
Key exclusion criteria (12 listed)
- Known history of documented gastroparesis
- Known history of functional dyspepsia
- Known / suspected current use of illicit drugs
- Known psychiatric or neurological illness
- Any prior gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
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 |
|---|---|---|
| Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)Also: VIPUN Gastric Monitoring System prototype 0.3The VIPUN Gastric Monitoring System prototype 0.3 comprises a nasogastric balloon catheter which is connected to an extracorporeal pressure sensor and data acquisition system. The device is placed during surgery. | Device | Panel 1 - High risk for postoperative ileus |
| Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)Also: VIPUN Gastric Monitoring System prototype 0.3The VIPUN Gastric Monitoring System prototype 0.3 comprises a nasogastric balloon catheter which is connected to an extracorporeal pressure sensor and data acquisition system. The device is placed upon the manifestation of clinical signs of postoperative ileus. | Device | Panel 2 - Postoperative ileus arm with investigational device |
Primary outcome
Feasibility (composite endpoint)
Time frame: Day 1 - Day 14
Composite endpoint comprising: procedural success (absence of protocol deviations with regard to motility measurement), tolerability of the device (non-validated questionnaire on nasopharyngeal discomfort and the incidence of intolerance resulting in early removal of the investigational device) and device-related safety (incidence of adverse device effects related to the use of the device).
8 secondary outcomes
Gastric motility
Time frame: Day 1 until termination motility recording (maximum 48 hours)
Evolution postoperative ileus - staff reported
Time frame: Day 1 until completion study procedures (maximum 14 days).
In hospital quality of life (EQ-5D-3L questionnaire)
Time frame: Day 1 until completion study procedures (maximum 14 days)
Device performance
Time frame: Day 1 until removal of device, no later than Day 14
Nausea severity
Time frame: Day 1 until completion study procedures (maximum 14 days)
Abdominal bloating severity
Time frame: Day 1 until completion study procedures (maximum 14 days)
Abdominal pain severity
Time frame: Day 1 until completion study procedures (maximum 14 days)
Abdominal discomfort severity
Time frame: Day 1 until completion study procedures (maximum 14 days)
Results and safety
The study was stopped early (reason given: Inadequate recruitment due to COVID-19 restrictions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Postoperative Ileus
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Not yet recruitingPhase 2
TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)
Delay in GI Recovery/Postoperative Ileus (POI)
RecruitingObservational study
The Value of Bowel Sounds in Evaluating Postoperative Intestinal Function Recovery in Colorectal Cancer Patients
Bowel Sounds, Colorectal Cancer
Recruiting
Oral Lactulose for Gastrointestinal Recovery After Complex Appendectomy
Ileus Postoperative, Gastrointestinal Function
Recruiting
Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Recovery in Patients Undergoing Major Abdominal Surgery
Postoperative Pain, 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System) and Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System) in people with Postoperative Ileus, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 12 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: stopped early, as of the sponsor's last update on 10 Feb 2021. 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 Belgium. 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. 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?
The study was stopped early (reason given: Inadequate recruitment due to COVID-19 restrictions.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (composite endpoint) (time frame: Day 1 - Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.