Mode
Text Size
Log in / Sign up
N/A N=77 Diagnostic

Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function

Gastrointestinal Diseases · Ileus Paralytic · Ileus

Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: GI Functional Recovery — 47.94 hours

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
G-tech WPS (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Yale University
Primary completion
Sep 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
GI Functional Recovery
47.94
SECONDARY
Postoperative Ileus
6
SECONDARY
Readmission With Ileus

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • Willing and able to provide informed consent
  • Eighteen (18) years of age or older
  • Subject is willing and able to follow all study requirements
  • Subject has undergone or will undergo a laparoscopic or open colorectal surgery with resection and anastomosis

Exclusion Criteria

  • Subject is pregnant or suspects pregnancy.
  • Known allergy to medical grade adhesive.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05298774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search