Not provided
Not provided
Not provided
Not provided
Inadequate recruitment due to COVID-19 restrictions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 1 - Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric motility | Long term motility index | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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%).
Not provided
Not provided
Not provided
Not provided
|
|
| Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System) | 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 upon the manifestation of clinical signs of postoperative ileus. |
|
|
| 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'. | Day 1 until completion study procedures (maximum 14 days) |
| Device performance | Incidence of device deficiencies | 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) | 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) | 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) | 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) | Day 1 until completion study procedures (maximum 14 days) |