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

StatusCompleted
PhaseNot applicable
Started2024-07-30
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information v13
Results posted: 2026-09-11
Enrollment target109→110
Primary endpoints2 to 1 entries
PercentageFidelity ofto encountersOrdering inPelvic whichFloor anorectalDiagnostics physiology testing is ordered and/or performed at the baseline routine-care gastroenterology office appointment Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointmentTreatment
2026-05-01
Study Status, Eligibility v12
Eligibility criteria-26 characters
Inclusion Criteria Participants: Participant has Chronic constipation as a main symptom Par [...] ticipate in pelvic floor physical therapy Exclusion Criteria Participants: Participant has taken narcotic pain medication in the past [...]
2025-09-09
Study Status, Oversight, Document Section v11
Re-verified, no change to tracked fields
2025-09-04
Enrolling by Invitation→Completed Study Status, Study Design v10
Trial statusEnrolling by Invitation→Completed
Primary completion dateestimated 2025-08→confirmed 2025-08-08
Completion dateestimated 2025-08→confirmed 2025-08-08
2025-07-08
Study Status, Study Description v9
Study description+228 characters
[...] mary endpoints given the nature of this being a pilot study. Registration NCT07032376 (Implementation Phase) is part of this registration, "Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation" (Observational Phase) NCT06352827.
Show 8 earlier versions
2025-04-15
Study Status, Oversight v8
Primary completion date2025-04→2025-08
Completion date2025-04→2025-08
2024-12-11
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v7
PhaseNot specified→Not applicable
Study description+986 characters
Per the NIH requirements the study team added the following language and also updated the registration to be an interventional study. The study will enroll adult patients with chronic constipation prior to appointment with a gastroenterologist that have not received anorectal function testing or tre [...]
2024-08-05
Study Status v6
Start dateestimated 2024-07→confirmed 2024-07-30
2024-07-22
Study Status, Arms and Interventions, Outcome Measures, Eligibility v5
Primary completion date2026-04→2025-04
Completion date2026-04→2025-04
Start date2024-06→2024-07
InterventionsSurveys (Behavioral)→Survey (Behavioral)
Eligibility criteria+66 characters
Inclusion Criteria Participants: - Participant has Chronic constipation as a main symptom Participant is able to participate in pelvic floor physical therapy Exclusion Criteria Participants: Participant has taken narco [...]
Secondary endpoints-265 characters
Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL) Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL)
Primary endpoints4 to 2 entries
Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM) Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM)
2024-06-21
Study Status, Eligibility v4
Eligibility criteria-64 characters
[...] tipation as a main symptom Exclusion Criteria Participants: Abdominal pain is the main symptom Bloating is the main symptom Participant has taken narcotic pain medication in the past 3 [...]
2024-06-04
Not Yet Recruiting→Enrolling by Invitation Study Status, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Enrolling by Invitation
Eligibility criteria+24 characters
[...] heduled to see a pelvic floor physical therapist in the past Participant is pregnant
Study sitescontacts updated at 1 of 1 site
2024-06-03
Study Status v2
Start date2024-05→2024-06
2024-05-02
Study Status v1
Start date2024-04→2024-05
2024-04-02
Original filing
The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation.
Trial Details
NCT Number NCT06352827
Lead Sponsor University of Michigan
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Constipation
Enrollment 110 participants
Start Date 2024-07-30
Primary Completion 2025-08-08 (estimated)
Study Completion 2025-08-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-11