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OpenTrials
Enrolling by Invitation

NCT Number: NCT07032376

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

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.

Enrolling by Invitation

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants:

  • Participant has Chronic constipation as a main symptom

Exclusion criteria

Participants:

  • 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 12 months
  • Participant has been scheduled to see a pelvic floor physical therapist in the past 12 months
  • Participant is pregnant

Treatment and study plan

survey

Behavioral

All participants will complete a baseline survey and have medical information collected.

Rectal Expulsion Device use

Behavioral

During the participant's clinic visit for constipation, the Rectal Expulsion Device will be available for the gastroenterology care provider to use if the decision is made to use this during the clinic visit.

In addition, the care provider will have access to the RED brochure and the Michigan Chart (MICHART) Our Practice Advisory (OPA) - a decision support tool in MiChart to support care navigation using RED.

Primary outcomes

  1. Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment

    Time frame: Day 1 (Baseline = initial appointment after consent)]

    Fidelity to ordering pelvic floor diagnostics

  2. Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment

    Time frame: Day 1 (Baseline = initial appointment after consent)]

    Fidelity to ordering pelvic floor treatment

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation- Phase 2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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