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ANTERO-5: Gastric Motility in Postoperative Ileus

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Terminated
CT.gov ID
NCT04100265
Collaborator
(none)
5
Enrollment
1
Location
3
Arms
15.2
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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%).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%).
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
ANTERO-5: A Clinical Investigation of Gastric Motility in Adult Patients at Risk to Develop Postoperative Ileus Following Colorectal Surgery
Actual Study Start Date :
Oct 16, 2019
Actual Primary Completion Date :
Jan 21, 2021
Actual Study Completion Date :
Jan 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Panel 1 - High risk for postoperative ileus

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)
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.
Other Names:
  • VIPUN Gastric Monitoring System prototype 0.3

    		•
    Experimental: Panel 2 - Postoperative ileus arm with investigational device

    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)
    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.
    Other Names:
  • VIPUN Gastric Monitoring System prototype 0.3

    		•
    No Intervention: Panel 3 - Postoperative ileus arm with standard of care

    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Gastric motility [Day 1 until termination motility recording (maximum 48 hours)]

      Long term motility index

    2. 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)

    3. 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'.

    4. Device performance [Day 1 until removal of device, no later than Day 14]

      Incidence of device deficiencies

    5. 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)

    6. 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)

    7. 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)

    8. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT04100265
    Other Study ID Numbers:
    • S63029
    First Posted:
    Sep 24, 2019
    Last Update Posted:
    Feb 10, 2021
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ileus

    Study Results

    No Results Posted as of Feb 10, 2021