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NCT04380090 · ClinicalTrials.gov registry record · Phase 2
Post-Operative Constipation Following Total Knee Arthroplasty
A Phase 2 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
NCT04380090 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 154 participants.
The verdict
NCT04380090, a Phase 2 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
Study Summary
Postoperative constipation, defined as no fully satisfying bowel movement within the first three postoperative days, is a common occurrence with some researchers estimating that between 41 and 85% of postoperative patients experience symptoms. Causes include intraoperative medications, postoperative opioid analgesics, decreased mobility, and decreased oral intake. Constipation significantly impacts quality of life following surgery. Current standard of care for preventing postoperative constipation for patients having a single total knee arthroplasty at Cleveland Clinic is discharge on postoperative day one with either a prescription to be filled for docusate sodium (brand name Colace®) 100 mg to be taken two times a day by mouth for twenty eight days or the filled prescription, plus discharge instructions on ways to avoid and treat constipation. Research results show that docusate sodium is ineffective for preventing postoperative constipation in orthopedic surgery patients, and anecdotal reports confirm this finding. The proposed study uses a 2-group non-equivalent cohort design to evaluate the effect of one standard dose (17 grams) of an over-the-counter osmotic laxative (propylene glycol (PEG 3350), brand name Miralax) by mouth prior to discharge to the current standard of care. The primary outcome measure is whether patients report of a fully satisfying, normal for them, bowel movement within the first three postoperative days. Patient reported data will be collected by phone call four to seven days following surgery. Pertinent patient characteristics will be abstracted from the electronic medical record. The sample will consist of patients over twenty years old having a single total knee arthroplasty by Drs. Stearns, Molloy, or Murray who are admitted to unit 5D at Cleveland Clinic Lutheran Hospital postoperatively. Intent to treat analysis will be performed using logistic and linear regression models, adjusting for differences between groups on patient and su
Interventions
- DRUG Propylene Glycol
- DRUG Docusate Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2020-02-21 |
| Est. Completion | 2020-07-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04380090
The ClinicalTrials.gov registry entry for NCT04380090 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Propylene Glycol is the first listed.
NCT04380090 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04380090 about?
NCT04380090 is a clinical study titled "Post-Operative Constipation Following Total Knee Arthroplasty". Postoperative constipation, defined as no fully satisfying bowel movement within the first three postoperative days, is a common occurrence with some researchers estimating that between 41 and 85% of postoperative patients experience symptoms. Causes include intraoperative medications, postoperative...
What is the current status of trial NCT04380090?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2020-02-21. Estimated completion is 2020-07-15.
What interventions are being tested in trial NCT04380090?
The interventions under investigation include: Propylene Glycol (DRUG), Docusate Sodium (DRUG).
Who is sponsoring clinical trial NCT04380090?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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