MedPath

A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation

Not Applicable
Not yet recruiting
Conditions
Constipation
Registration Number
NCT07032376
Lead Sponsor
University of Michigan
Brief Summary

This research is studying how the availability of a Food and Drug Administration (FDA)-cleared point-of-care, bedside device bedside device called Rectal Expulsion Device (RED) can be used to evaluate constipation in the participants' routine office visit with the participants' care provider. In this research, participants will be asked to complete a survey prior to the gastroenterology office consultation. Health-related information will be collected for this research study. There are no additional study visits for this research study.

Detailed Description

This registration is (Implementation Phase) for the registered study "Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation" (Observational Phase) NCT06352827.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
109
Inclusion Criteria
  • Participant has Chronic constipation as a main symptom
  • Participant is able to participate in pelvic floor physical therapy
Exclusion Criteria
  • Participant has taken narcotic pain medication in the past 30 days
  • Participant has been scheduled for a test called an anorectal manometry in the past
  • Participant has been scheduled to see a pelvic floor physical therapist in the past
  • Participant is pregnant

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointmentDay 1 (Baseline = initial appointment after consent)]

Fidelity to ordering pelvic floor diagnostics

Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointmentDay 1 (Baseline = initial appointment after consent)]

Fidelity to ordering pelvic floor treatment

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Brenda Ayala
Contact
734-936-4780
beayala@umich.edu
Eric Shah, MD
Principal Investigator
© Copyright 2025. All Rights Reserved by MedPath