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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
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.
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.
UZ Leuven
Leuven, Belgium
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).
Time frame: Day 1 - Day 14
Gastric motility
Long term motility index
Time frame: Day 1 until termination motility recording (maximum 48 hours)
Evolution postoperative ileus - staff reported
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).
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'.
Time frame: Day 1 until completion study procedures (maximum 14 days)
Device performance
Incidence of device deficiencies
Time frame: Day 1 until removal of device, no later than Day 14
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Nausea severity
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)
Abdominal bloating severity
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)
Abdominal pain severity
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)
Abdominal discomfort severity
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)