NCT04329715: EVeRLAST

Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse

Completed NA Last updated 8 March 2022

What this trial tests

NA trial testing Expedited postoperative activity instructions in Pelvic Organ Prolapse in 123 participants. Completed in 15 February 2022.

Timeline

1 July 2020

Primary endpoint
15 February 2022

15 February 2022

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	123
Start date	1 July 2020
Primary completion	15 February 2022
Estimated completion	15 February 2022
Sites	1 location across United States

Drugs / interventions tested

• Expedited postoperative activity instructions
• Standard postoperative activity restructions

Conditions studied

• Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →

Sponsor

Duke University

Who can join

Eligibility, female only, with Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Standard Restrictions vs Expedited Activity After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial.
   O'Shea M, Siddiqui NY, Truong T, Erkanli A, et al · · 2023 · cited 7× · PMID 37256578 · DOI 10.1001/jamasurg.2023.1649