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NCT03738904 · ClinicalTrials.gov registry record · Phase 4
Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery
A Phase 4 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 111
- Enrollment target
NCT03738904 is a Phase 4 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 111 participants.
The verdict
NCT03738904, a Phase 4 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 111 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate whether being randomized to an aggressive postoperative non-narcotic pain regimen that treats pain from multiple different pathways may decrease postoperative pain levels, decrease constipation, and decrease the dependency on opioid medications after anorectal surgery versus the standard of care for managing pain. This use of a more aggressive pain regimen is considered an enhanced recovery after surgery (ERAS) protocol because it is theorized to improve or "enhance" postoperative recovery by both decreasing the use of narcotics and their detrimental effects as well as increasing the benefit of using additional non-narcotic pain medication.
Interventions
- COMBINATION_PRODUCT ERAS
- COMBINATION_PRODUCT Standard of care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2018-10-26 |
| Est. Completion | 2022-08-18 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03738904
The ClinicalTrials.gov registry entry for NCT03738904 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ERAS is the first listed.
NCT03738904 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03738904 about?
NCT03738904 is a clinical study titled "Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery". The purpose of the study is to evaluate whether being randomized to an aggressive postoperative non-narcotic pain regimen that treats pain from multiple different pathways may decrease postoperative pain levels, decrease constipation, and decrease the dependency on opioid medications after anorectal...
What is the current status of trial NCT03738904?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 111 participants. The study started on 2018-10-26. Estimated completion is 2022-08-18.
What interventions are being tested in trial NCT03738904?
The interventions under investigation include: ERAS (COMBINATION_PRODUCT), Standard of care (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03738904?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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