An interventional study of 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 Postoperative Ileus, sponsored by Universitaire Ziekenhuizen KU Leuven. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-10.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Device feasibility
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.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 5 is below the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Panel 1 - High risk for postoperative ileus (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.
Device: Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)
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.
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.
Also known as: 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.
Also known as: VIPUN Gastric Monitoring System prototype 0.3
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).
Time frame: Day 1 - Day 14
Gastric motility
Long term motility index
Time frame: 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)
Time frame: 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'.
Time frame: Day 1 until completion study procedures (maximum 14 days)
Device performance
Incidence of device deficiencies
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 1 until completion study procedures (maximum 14 days)
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2019 to primary completion in Jan 2021, 15 months.
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This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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