Clinical trial NCT04100265: ANTERO-5: Gastric Motility in Postoperative Ileus
Official title: ANTERO-5: A Clinical Investigation of Gastric Motility in Adult Patients at Risk to Develop Postoperative Ileus Following Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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%).
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility (composite endpoint)
timeFrame: Day 1 - Day 14
Secondary outcomes:
measure: Gastric motility
timeFrame: Day 1 until termination motility recording (maximum 48 hours)
measure: Evolution postoperative ileus - staff reported
timeFrame: Day 1 until completion study procedures (maximum 14 days).
measure: In hospital quality of life (EQ-5D-3L questionnaire)
timeFrame: Day 1 until completion study procedures (maximum 14 days)
measure: Device performance
timeFrame: Day 1 until removal of device, no later than Day 14
measure: Nausea severity
timeFrame: Day 1 until completion study procedures (maximum 14 days)
measure: Abdominal bloating severity
timeFrame: Day 1 until completion study procedures (maximum 14 days)
measure: Abdominal pain severity
timeFrame: Day 1 until completion study procedures (maximum 14 days)
measure: Abdominal discomfort severity
timeFrame: Day 1 until completion study procedures (maximum 14 days)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: