ANTERO-5: Gastric Motility in Postoperative Ileus

Postoperative Ileus Clinical Trial

— ANTERO-5  

Official title:

ANTERO-5: A Clinical Investigation of Gastric Motility in Adult Patients at Risk to Develop Postoperative Ileus Following Colorectal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04100265
• Other study ID #: S63029
• Status: Terminated
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: January 21, 2021

Study information

• Verified date: November 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gastric motility	Long term motility index	Day 1 until termination motility recording (maximum 48 hours)
Secondary	Evolution postoperative ileus - staff reported	Incidence of markers of resolution of postoperative ileus (first flatus, bowel sounds, bowel movements, solid food tolerance)	Day 1 until completion study procedures (maximum 14 days).
Secondary	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'.	Day 1 until completion study procedures (maximum 14 days)
Secondary	Device performance	Incidence of device deficiencies	Day 1 until removal of device, no later than Day 14
Secondary	Nausea severity	Patient reported severity of nausea (100 mm visual analogue scale ranging from Absent to Worst possible)	Day 1 until completion study procedures (maximum 14 days)
Secondary	Abdominal bloating severity	Patient reported severity of abdominal bloating (100 mm visual analogue scale ranging from Absent to Worst possible)	Day 1 until completion study procedures (maximum 14 days)
Secondary	Abdominal pain severity	Patient reported severity of abdominal pain (100 mm visual analogue scale ranging from Absent to Worst possible)	Day 1 until completion study procedures (maximum 14 days)
Secondary	Abdominal discomfort severity	Patient reported severity of abdominal discomfort (100 mm visual analogue scale ranging from Absent to Worst possible)	Day 1 until completion study procedures (maximum 14 days)