NCT05298774

Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function

Completed NA Results posted Last updated 3 August 2025

What this trial tests

NA trial testing G-tech WPS in Gastrointestinal Diseases in 77 participants. Completed in 1 September 2024.

Timeline

1 June 2022

Primary endpoint
1 September 2024

1 September 2024

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	77
Start date	1 June 2022
Primary completion	1 September 2024
Estimated completion	1 September 2024
Sites	1 location across United States

Drugs / interventions tested

• G-tech WPS

Conditions studied

• Gastrointestinal Diseases — all drugs for Gastrointestinal Diseases →
• Ileus Paralytic — all drugs for Ileus Paralytic →
• Ileus — all drugs for Ileus →

Sponsor

Yale University

Who can join

18 and older, any sex, with Gastrointestinal Diseases or Ileus Paralytic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

GI Functional Recovery Primary · 30 days after index surgery

Time to return of flatus or bowel movement after colorectal surgery

Group	Value	95% CI
Postoperative Recovery With G-tech WPS	47.94	± 30.78

Postoperative Ileus Secondary · 30 days after index surgery

Occurrence of postoperative ileus after colorectal surgery

Group	Value	95% CI
Postoperative Recovery With G-tech WPS	6

Readmission With Ileus Secondary · 30 days after index surgery

Occurrence of readmission with postoperative ileus after colorectal surgery

Group	Value	95% CI
Postoperative Recovery With G-tech WPS	0

Sponsor's own description

The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Subsequently the data will be studied to establish which information in the signals is important in determining when to feed patients and possibly discharge them.

These pilot prospective, open clinical studies suggests that myoelectrical activity, measured on the abdominal surface with a noninvasive wireless patch system, carries predictive value in determining time to feeding and time to flatus following open abdominal surgery. Having such information in advance of clinical measures could facilitate timely interventions, be it early feeding or delaying feeding as dictated by the patient's unique recovery profile. The G-Tech Wireless Patch System would provide a unique insight into the process allowing for a tailored protocol that could improve patient satisfaction and optimize recovery. The system could also enable feedback on the impact to the overall gastrointestinal myoelectrical activity of medications, particularly opioids, used for pain management that are known to inhibit gastrointestinal function by disrupting the normal recovery patterns of colonic motility.23-25 While it remains to be seen, in addition to predicting time to flatus/bowel movement early on, the ability to continue monitoring the patient may allow one to predict onset of secondary complications, such as wound infections or anastomotic leaks, that are associated with ileus. Similarly, given the wireless noninvasive nature of the system the patients could be discharged home with the patches, whereby they would serve as a remote monitoring tool. This could be particularly useful in cases where the patients may have been discharged early and may be at a high risk for readmission. The system would then send updates/alerts to the care team for management and potentially avoid preventable readmissions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.