Postoperative Ileus
Conditions
Brief 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.
Interventions
DEVICEPanel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)
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.
DEVICEPanel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)
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.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention 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%).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (composite endpoint) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution postoperative ileus - staff reported | Day 1 until completion study procedures (maximum 14 days). | Incidence of markers of resolution of postoperative ileus (first flatus, bowel sounds, bowel movements, solid food tolerance) |
| In hospital quality of life (EQ-5D-3L questionnaire) | Day 1 until completion study procedures (maximum 14 days) | 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'. |
| Device performance | Day 1 until removal of device, no later than Day 14 | Incidence of device deficiencies |
| Gastric motility | Day 1 until termination motility recording (maximum 48 hours) | Long term motility index |
| Abdominal bloating severity | Day 1 until completion study procedures (maximum 14 days) | Patient reported severity of abdominal bloating (100 mm visual analogue scale ranging from Absent to Worst possible) |
| Abdominal pain severity | Day 1 until completion study procedures (maximum 14 days) | Patient reported severity of abdominal pain (100 mm visual analogue scale ranging from Absent to Worst possible) |
| Abdominal discomfort severity | Day 1 until completion study procedures (maximum 14 days) | Patient reported severity of abdominal discomfort (100 mm visual analogue scale ranging from Absent to Worst possible) |
| Nausea severity | Day 1 until completion study procedures (maximum 14 days) | Patient reported severity of nausea (100 mm visual analogue scale ranging from Absent to Worst possible) |
Countries
Belgium
Outcome results
None listed