Clinical trial NCT03505476: Optimizing the Previs Device for Prediction of Postoperative Ileus
Official title: Optimizing the Previs Device for Prediction of Postoperative Ileus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileus
Keywords: Ileus
Abdominal surgery
Bowel obstruction
Postoperative Ileus
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects consented and enrolled will receive the same intervention. There is no control group.
Primary purpose: DIAGNOSTIC

Brief summary: The research proposed in this study will develop a noninvasive prototype device that will capture intestinal sounds, process signals, and display predictive information in real-time at the point-of-care using algorithms already developed at this institution.

Detailed description: Following major abdominal surgery, up to 30% of patients develop a poorly understood condition known as ileus. When ileus occurs, the bowels shut down and patients often develop abdominal dissension, nausea, vomiting, and even more serious complications. Because this condition does not develop until many days after surgery has been completed, clinicians do not know if they should begin allowing patients to eat or withhold nutrition until they show signs of bowel function such as passing gas or having bowel movements. Clinicians have different approaches but none are ideal: 1) feed all patients early and the ones that develop an ileus will have their diets reverse, suction tube placed in their stomach, and hopefully don't get develop more serious complications, or 2) don't feed patients until they pass gas or have a bowel movement, which delays nutrition and prolongs hospital stays for the 70% of patients who will not develop an ileus

Participants in this study will be asked to wear a 3-ounce device that adheres to the skin of the abdominal wall for 10 days. They will also be asked to answer questions each day of their hospital stay regarding how they have tolerated eating.

Eligibility criteria: Inclusion Criteria:

Patients undergoing elective intestinal resection surgery by the colorectal surgery service at UIHC.

Age 18 to 100.

Exclusion Criteria:

Allergies to any of the device components. Inability to have prototype device applied to their abdominal wall due to a condition (ie:fistulas, stomas, drains, etc).

Primary outcomes:
measure: Device Sensitivity for Predicting Ileus.
timeFrame: Each patient's device's data was assessed at day 15.
measure: Device Specificity for Predicting Ileus
timeFrame: Each patient's device's data was assessed at day 15.
measure: Device Positive Predictive Value for Predicting Ileus
timeFrame: Each patient's device's data was assessed at day 15.
measure: Device Negative Predictive Value for Predicting Ileus
timeFrame: Each patient's device's data was assessed at day 15.
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Jennifer Hrabe
role: PRINCIPAL_INVESTIGATOR
References: