ANTERO-5: Gastric Motility in Postoperative Ileus

Universitaire Ziekenhuizen KU Leuven

Status: Terminated

Conditions: Postoperative Ileus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04100265

S63029

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 3 patient groups

Panel 1 - High risk for postoperative ileus

Experimental group

Description:

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.

Treatment:

Device: Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)

Panel 2 - Postoperative ileus arm with investigational device

Experimental group

Description:

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.

Treatment:

Device: Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)

Panel 3 - Postoperative ileus arm with standard of care

No Intervention group

Description:

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.