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ANTERO-5: Gastric Motility in Postoperative Ileus (ANTERO-5)

Primary Purpose

Postoperative Ileus

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)
Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Panel 1 - High risk for postoperative ileus

Panel 2 - Postoperative ileus arm with investigational device

Panel 3 - Postoperative ileus arm with standard of care

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Gastric motility
Long term motility index
Evolution postoperative ileus - staff reported
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)
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'.
Device performance
Incidence of device deficiencies
Nausea severity
Patient reported severity of nausea (100 mm visual analogue scale ranging from Absent to Worst possible)
Abdominal bloating severity
Patient reported severity of abdominal bloating (100 mm visual analogue scale ranging from Absent to Worst possible)
Abdominal pain severity
Patient reported severity of abdominal pain (100 mm visual analogue scale ranging from Absent to Worst possible)
Abdominal discomfort severity
Patient reported severity of abdominal discomfort (100 mm visual analogue scale ranging from Absent to Worst possible)

Full Information

First Posted
September 11, 2019
Last Updated
February 5, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04100265
Brief Title
ANTERO-5: Gastric Motility in Postoperative Ileus
Acronym
ANTERO-5
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruitment due to COVID-19 restrictions.
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
January 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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%).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panel 1 - High risk for postoperative ileus
Arm Type
Experimental
Arm 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.
Arm Title
Panel 2 - Postoperative ileus arm with investigational device
Arm Type
Experimental
Arm 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.
Arm Title
Panel 3 - Postoperative ileus arm with standard of care
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)
Other Intervention Name(s)
VIPUN Gastric Monitoring System prototype 0.3
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)
Other Intervention Name(s)
VIPUN Gastric Monitoring System prototype 0.3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility (composite endpoint)
Description
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).
Time Frame
Day 1 - Day 14
Secondary Outcome Measure Information:
Title
Gastric motility
Description
Long term motility index
Time Frame
Day 1 until termination motility recording (maximum 48 hours)
Title
Evolution postoperative ileus - staff reported
Description
Incidence of markers of resolution of postoperative ileus (first flatus, bowel sounds, bowel movements, solid food tolerance)
Time Frame
Day 1 until completion study procedures (maximum 14 days).
Title
In hospital quality of life (EQ-5D-3L questionnaire)
Description
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'.
Time Frame
Day 1 until completion study procedures (maximum 14 days)
Title
Device performance
Description
Incidence of device deficiencies
Time Frame
Day 1 until removal of device, no later than Day 14
Title
Nausea severity
Description
Patient reported severity of nausea (100 mm visual analogue scale ranging from Absent to Worst possible)
Time Frame
Day 1 until completion study procedures (maximum 14 days)
Title
Abdominal bloating severity
Description
Patient reported severity of abdominal bloating (100 mm visual analogue scale ranging from Absent to Worst possible)
Time Frame
Day 1 until completion study procedures (maximum 14 days)
Title
Abdominal pain severity
Description
Patient reported severity of abdominal pain (100 mm visual analogue scale ranging from Absent to Worst possible)
Time Frame
Day 1 until completion study procedures (maximum 14 days)
Title
Abdominal discomfort severity
Description
Patient reported severity of abdominal discomfort (100 mm visual analogue scale ranging from Absent to Worst possible)
Time Frame
Day 1 until completion study procedures (maximum 14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ANTERO-5: Gastric Motility in Postoperative Ileus

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