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NCT04329715 · ClinicalTrials.gov registry record · NA
Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 123
- Enrollment target
NCT04329715: Completed NA study, sponsored by Duke University.
NCT04329715 is a NA study that has completed, run by Duke University. The registered enrollment target is 123 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04329715, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 123 participants
- Enrollment target
Study Summary
The objective of the EVeRLAST study is to determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to short-term anatomic prolapse outcomes. We hypothesize that immediate resumption of physical activities as tolerated will result in noninferior surgical outcomes following prolapse surgery when compared to standard postoperative activity restrictions. Participants will be enrolled and randomized at their preoperative clinic visit to one of two treatment arms: Arm 1: Standard instructions (no heavy lifting over 10lbs for 6 weeks; return to work at 4 weeks for sedentary work and 6 weeks for manual labor) Arm 2: Liberal instructions (no restrictions; resume activities and work as soon as able) We will also collect subjective and objective measures of pre- and postoperative physical activity, through the use of patient-reported physical activity assessments and wrist-worn accelerometers. Accelerometer data will be collected at the preoperative, 2-week-postoperative, and 6-week-postoperative time points. Accelerometer data will also be used to calculate time to resumption of normal activities, defined as time at which a patient resumes greater than 90% of her baseline preoperative level of physical activity. We will additionally be collecting data on relevant patient-reported outcomes of pelvic floor symptom severity, health-related quality of life measures, postoperative pain, time to return to work (where relevant), and patient global impression of improvement. Postoperative anatomic assessments will be performed at 6 weeks and 3 months postoperatively by blinded study personnel
Primary Outcome
Most distal point of pelvic organ support (in centimeters) based on Pelvic Organ Prolapse Quantification system
Interventions
- BEHAVIORAL Expedited postoperative activity instructions
- BEHAVIORAL Standard postoperative activity restructions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2022-02-15 |
| Phase | NA |
What the finished NCT04329715 record still lists
NCT04329715 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Expedited postoperative activity instructions is the first listed.
NCT04329715 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04329715 about?
NCT04329715 is a clinical study titled "Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse". The objective of the EVeRLAST study is to determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to short-term anatomic prolapse outcomes. We hypothesize that immediate resumption of physical activities as tolerated will...
What is the current status of trial NCT04329715?
This trial is currently completed. It is a NA study. The enrollment target is 123 participants. The study started on 2020-07-01. Estimated completion is 2022-02-15.
What interventions are being tested in trial NCT04329715?
The interventions under investigation include: Expedited postoperative activity instructions (BEHAVIORAL), Standard postoperative activity restructions (BEHAVIORAL).
Who is sponsoring clinical trial NCT04329715?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04329715's enrollment target sits among peer trials
123 762nd of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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