Postoperative Ileus Clinical Trial
— ANTERO-5Official title:
ANTERO-5: A Clinical Investigation of Gastric Motility in Adult Patients at Risk to Develop Postoperative Ileus Following Colorectal Surgery
Verified date | November 2019 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | January 21, 2021 |
Est. primary completion date | January 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Gastric motility | Long term motility index | Day 1 until termination motility recording (maximum 48 hours) | |
Secondary | Evolution postoperative ileus - staff reported | Incidence of markers of resolution of postoperative ileus (first flatus, bowel sounds, bowel movements, solid food tolerance) | Day 1 until completion study procedures (maximum 14 days). | |
Secondary | 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) | |
Secondary | Device performance | Incidence of device deficiencies | Day 1 until removal of device, no later than Day 14 | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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