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NCT05542836 · ClinicalTrials.gov registry record
EVeRLAST 2-Year Follow-Up
A clinical trial of Pelvic Organ Prolapse, sponsored by Duke University.
- Completed
- Registry status
- 63
- Enrollment target
- 1
- Study location
NCT05542836: Completed study of Pelvic Organ Prolapse, sponsored by Duke University.
NCT05542836 is a study of Pelvic Organ Prolapse that has completed, run by Duke University. The registered enrollment target is 63 participants, below the 144-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05542836, a study of Pelvic Organ Prolapse, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 2-year follow-up study from EVeRLAST which objective was to determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to short-term anatomic prolapse outcomes. The preliminary data from the original study suggest expedited instructions are non-inferior. We hypothesize this effect continues at the 2-year postoperative mark and patients continue to have non-inferior outcomes after prolapse surgery when compared to standard postoperative activity restrictions. Participants from the original EVeRLAST will be approached to assess their interest in participating in the 2-year follow up study. We will be collecting objective and subjective data.
Primary Outcome
The POPDI results in scores ranging from 0 to 300; higher scores indicate greater symptom distress.
Conditions Studied
Interventions
- BEHAVIORAL Expedited postoperative activity instructions
- BEHAVIORAL Standard postoperative activity restructions
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2022-09-30 |
| Est. Completion | 2023-09-27 |
What the finished NCT05542836 record still lists
NCT05542836 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 144-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 2 interventions - of which Expedited postoperative activity instructions is the first listed.
NCT05542836 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05542836 about?
NCT05542836 is a clinical study titled "EVeRLAST 2-Year Follow-Up". This is a 2-year follow-up study from EVeRLAST which objective was to determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to short-term anatomic prolapse outcomes. The preliminary data from the original study suggest ...
What is the current status of trial NCT05542836?
This trial is currently completed. The enrollment target is 63 participants. The study started on 2022-09-30. Estimated completion is 2023-09-27.
What conditions does trial NCT05542836 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse.
What interventions are being tested in trial NCT05542836?
The interventions under investigation include: Expedited postoperative activity instructions (BEHAVIORAL), Standard postoperative activity restructions (BEHAVIORAL).
Who is sponsoring clinical trial NCT05542836?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05542836 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05542836's enrollment target sits among peer trials
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