ANTERO-5: Gastric Motility in Postoperative Ileus

NCT04100265 | Terminated

• 1 other identifier: S63029
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Gastric motility

  Day 1 until termination motility recording (maximum 48 hours)

• Evolution postoperative ileus - staff reported

  Day 1 until completion study procedures (maximum 14 days).

• In hospital quality of life (EQ-5D-3L questionnaire)

  Day 1 until completion study procedures (maximum 14 days)

• Device performance

  Day 1 until removal of device, no later than Day 14

• Nausea severity

  Day 1 until completion study procedures (maximum 14 days)

Study Arms (3)

Panel 1 - High risk for postoperative ileus

EXPERIMENTAL

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.

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

Panel 2 - Postoperative ileus arm with investigational device

EXPERIMENTAL

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.

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

Panel 3 - Postoperative ileus arm with standard of care

NO INTERVENTION

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.

Interventions

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

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.

Also known as: VIPUN Gastric Monitoring System prototype 0.3

Panel 1 - High risk for postoperative ileus

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

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.

Also known as: VIPUN Gastric Monitoring System prototype 0.3

Panel 2 - Postoperative ileus arm with investigational device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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%).

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 24, 2019
• Study Start: October 16, 2019
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: February 10, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)