EVeRLAST 2-Year Follow-Up

2-Year Follow-Up: Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse (EVeRLAST)

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Behavioral: Expedited postoperative activity instructions; Behavioral: Standard postoperative activity restructions

Detailed Description

Activity recommendations and lifting restrictions after gynecologic surgery are based on tradition and anecdote. Despite the paucity of evidence to support such recommendations, in a recent survey, 82-86% of minimally invasive gynecologic surgeons recommended postoperative lifting restrictions. Meanwhile, other surgical specialties have begun to depart from these traditional restrictions, recognizing not only the unclear health benefits of a prolonged convalescence, but the economic implications of arbitrarily restricting postoperative labor force participation. For example, following inguinal hernia repair, patients who were able to decide when to return to work took a significantly shorter period of sick leave and hernia recurrence was not found to be higher in those resuming activities the day after surgery.

With respect to prolapse surgery, recommendations related to weight restrictions are primarily based upon theoretical avoidance of intra-abdominal pressure which could compromise the success of a recent reconstructive pelvic floor surgery. However, in a research study of healthy volunteers, daily physiologic events such as Valsalva, coughing, and rising from supine to upright positions generated considerably more intra-abdominal pressure than lifting. In animal studies, mechanical stimulation improves skeletal muscle healing by promoting remodeling, myoblast chemotaxis, and differentiation.6 Thus studies have challenged the notion that avoidance of weight-bearing activities is protective to the reconstructed pelvic floor.

In a recent randomized controlled trial of restrictive versus liberal activity recommendations following prolapse surgery, liberal activity recommendations were associated with similar patient satisfaction yet no differences in short-term anatomic outcomes. While this study added important evidence, it was not powered to detect differences in early anatomic prolapse recurrence, and the literature remains inconclusive regarding the risks (or absence thereof) of recommending liberal resumption of activities following prolapse surgery.

Therefore, the objective of the EVeRLAST study is to conclusively determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to anatomic and functional outcomes. We recently presented short-term outcome data, collected three months after surgery, which confirmed that expedited activity is non-inferior to standard activity limitations. We now propose to further follow this study population, with repeat assessments two years after surgery. We hypothesize that those who received expedited postoperative activity instructions will continue to demonstrate non-inferior anatomic and symptomatic outcomes two years after prolapse surgery. We will test this hypothesis by completing the following specific aims.

The follow-up will be conducted remotely via Zoom interviews.

Specific Aim 1: Determine if expedited resumption of postoperative activity levels results in non-inferior symptomatic outcomes when compared to standard activity restrictions at two years after the original surgery.

Specific Aim 2: Compare objective and subjective measures of physical function two years after surgery between those receiving expedited versus standard activity restrictions. Measures include a 2-minute walk test (2MWT), chair stand test, and the Activities Assessment Scale (AAS).

Specific Aim 3: Compare objective and subjective measures of and pelvic floor function two years after surgery in those receiving expedited versus standard activity restrictions. Main outcomes include retreatment (e.g., pessary, surgery), objective anatomic POPQ data, where available, the Pelvic Floor Distress Inventory (PFDI) and impression of improvement using the Patient Global Impression of Improvement scale (PGI-I).

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Eligible subjects include all patients from the prior EVeRLAST study.

Description

Inclusion Criteria:

• Patient who were previously enrolled in the initial EVeRLAST study.

Exclusion Criteria:

• Enrollment in another research study of pelvic organ prolapse.
• Any patients who underwent further surgery in the 3 months following their prolapse surgery or patients who underwent unanticipated treatment which would result in prolonged inactivity (such as a cancer diagnosis) 3 months following their prolapse surgery.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Expedited postoperative activity instructions; Ad lib postoperative activity and return to work recommendations	Behavioral: Expedited postoperative activity instructions; Ad lib postoperative activity and return to work recommendations
Standard postoperative activity restrictions; Standard conservative postoperative activity and return to work recommendations	Behavioral: Standard postoperative activity restructions; Standard conservative postoperative activity and return to work recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolapse symptoms measured by the Pelvic Organ Prolapse Distress Inventory (POPDI)	The POPDI results in scores ranging from 0 to 300; higher scores indicate greater symptom distress.	2 year +/- 1 month following the initial prolapse surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional activity measured by the Activities Assessment Scale (AAS)	The AAS results in scores that range from 0 to 100; higher scores indicate better physical function/	2 year +/- 1 month following the initial prolapse surgery
Physical function assessed by the Global Impression of Improvement	The Global Impression of Improvement results in scores ranging from 1 to 7; higher scores indicate a worse perception of improvement.	2 year +/- 1 month following the initial prolapse surgery
Physical function assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form	T-scores will be presented with higher scores represent more of the concept being measured	2 year +/- 1 month following the initial prolapse surgery
Pelvic floor symptom severity measured by the Pelvic Floor Distress Index (PFDI-20)	The PFDI-20 results in scores from 0 to 30; higher scores indicate greater symptom distress	2 year +/- 1 month following the initial prolapse surgery
Physical function as measured by a 2-minute walk test (2MWT)		2 years +/- 1 month following the initial prolapse surgery
Physical function as measured by a chair stand test.		2 year +/- 1 month following the initial prolapse surgery

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: PRO00104389_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No