Trial Outcomes & Findings for Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function (NCT NCT05298774)

NCT ID: NCT05298774

Last Updated: 2025-08-03

Results Overview

Time to return of flatus or bowel movement after colorectal surgery

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

77 participants

Primary outcome timeframe

30 days after index surgery

Results posted on

2025-08-03

Participant Flow

Participant milestones

Participant milestones
Measure
Postoperative Recovery With G-tech WPS
Patients had G-tech WPS patches applied and activated within 4 hours of surgery
Overall Study
STARTED
77
Overall Study
COMPLETED
68
Overall Study
NOT COMPLETED
9

Reasons for withdrawal

Reasons for withdrawal
Measure
Postoperative Recovery With G-tech WPS
Patients had G-tech WPS patches applied and activated within 4 hours of surgery
Overall Study
Physician Decision
3
Overall Study
Withdrawal by Subject
2
Overall Study
Lost to Follow-up
3
Overall Study
Screen failure
1

Baseline Characteristics

Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Postoperative Recovery With G-tech WPS
n=77 Participants
Patients had G-tech WPS patches applied and activated within 4 hours of surgery
Age, Continuous
62.42 years
STANDARD_DEVIATION 12.72 • n=5 Participants
Sex: Female, Male
Female
40 Participants
n=5 Participants
Sex: Female, Male
Male
37 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
70 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
Race (NIH/OMB)
White
67 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Height
170.27 cm
STANDARD_DEVIATION 10.60 • n=5 Participants
Weight
79.88 kg
STANDARD_DEVIATION 19.43 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days after index surgery

Population: Of the 77 participants assigned to the arm, 7 did not receive the G-tech WPS patches after enrollment, and outcome data was not recorded for 3 additional participants. Therefore, 67 participants were included in the analysis population.

Time to return of flatus or bowel movement after colorectal surgery

Outcome measures

Outcome measures
Measure
Postoperative Recovery With G-tech WPS
n=67 Participants
G-tech WPS: G-tech WPS patches applied and activated within 4 hours of surgery
GI Functional Recovery
47.94 hours
Standard Deviation 30.78

SECONDARY outcome

Timeframe: 30 days after index surgery

Occurrence of postoperative ileus after colorectal surgery

Outcome measures

Outcome measures
Measure
Postoperative Recovery With G-tech WPS
n=77 Participants
G-tech WPS: G-tech WPS patches applied and activated within 4 hours of surgery
Postoperative Ileus
6 Participants

SECONDARY outcome

Timeframe: 30 days after index surgery

Occurrence of readmission with postoperative ileus after colorectal surgery

Outcome measures

Outcome measures
Measure
Postoperative Recovery With G-tech WPS
n=77 Participants
G-tech WPS: G-tech WPS patches applied and activated within 4 hours of surgery
Readmission With Ileus
0 Participants

Adverse Events

Postoperative Recovery With G-tech WPS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ira Leeds

Yale University

Phone: (203)785-2616

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place