- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04100265
ANTERO-5: Gastric Motility in Postoperative Ileus (ANTERO-5)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- UZ Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DEVICE_FEASIBILITY
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Panel 1 - High risk for postoperative ileus
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.
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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.
Other Names:
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EXPERIMENTAL: Panel 2 - Postoperative ileus arm with investigational device
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.
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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.
Other Names:
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NO_INTERVENTION: Panel 3 - Postoperative ileus arm with standard of care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility (composite endpoint)
Time Frame: Day 1 - Day 14
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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).
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Day 1 - Day 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric motility
Time Frame: Day 1 until termination motility recording (maximum 48 hours)
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Long term motility index
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Day 1 until termination motility recording (maximum 48 hours)
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Evolution postoperative ileus - staff reported
Time Frame: Day 1 until completion study procedures (maximum 14 days).
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Incidence of markers of resolution of postoperative ileus (first flatus, bowel sounds, bowel movements, solid food tolerance)
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Day 1 until completion study procedures (maximum 14 days).
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In hospital quality of life (EQ-5D-3L questionnaire)
Time Frame: Day 1 until completion study procedures (maximum 14 days)
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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'. |
Day 1 until completion study procedures (maximum 14 days)
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Device performance
Time Frame: Day 1 until removal of device, no later than Day 14
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Incidence of device deficiencies
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Day 1 until removal of device, no later than Day 14
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Nausea severity
Time Frame: Day 1 until completion study procedures (maximum 14 days)
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Patient reported severity of nausea (100 mm visual analogue scale ranging from Absent to Worst possible)
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Day 1 until completion study procedures (maximum 14 days)
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Abdominal bloating severity
Time Frame: Day 1 until completion study procedures (maximum 14 days)
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Patient reported severity of abdominal bloating (100 mm visual analogue scale ranging from Absent to Worst possible)
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Day 1 until completion study procedures (maximum 14 days)
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Abdominal pain severity
Time Frame: Day 1 until completion study procedures (maximum 14 days)
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Patient reported severity of abdominal pain (100 mm visual analogue scale ranging from Absent to Worst possible)
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Day 1 until completion study procedures (maximum 14 days)
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Abdominal discomfort severity
Time Frame: Day 1 until completion study procedures (maximum 14 days)
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Patient reported severity of abdominal discomfort (100 mm visual analogue scale ranging from Absent to Worst possible)
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Day 1 until completion study procedures (maximum 14 days)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S63029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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li xiongUnknown
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Gabriele Baldini, MD, MSc, Assistant ProfessorCompleted
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