ANTERO-5: Gastric Motility in Postoperative Ileus

Not Applicable

Terminated

• Conditions: Postoperative Ileus
• Interventions: Device: Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System); Device: Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)

• Registration Number: NCT04100265
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-24
• Study Start: 2019-10-16
• Status Verified: 2019-11
• Primary Completion: 2021-01-21
• Study Completion: 2021-01-21
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Panel 2 - Postoperative ileus arm with investigational device	Panel 2 - Postoperative ileus arm with investigational device (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.
Panel 1 - High risk for postoperative ileus	Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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'.
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)
Gastric motility	Day 1 until termination motility recording (maximum 48 hours)	Long term motility index
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)
Device performance	Day 1 until removal of device, no later than Day 14	Incidence of device deficiencies

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium