Active Recovery Program for Post-Surgery Recovery of Pelvic Surgery

Overseen By Women's Health Research Unit Department of Ob/Gyn

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Chronic opioids

Disqualifiers: Mobility issues, Balance problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new active recovery program for individuals who have recently undergone pelvic reconstructive surgery. The study compares standard care instructions with a program that includes specific walking goals and exercises for the abdomen and pelvic floor. It targets those who have had minimally invasive pelvic surgery and can manage moderate walking without assistance. Participants should not have balance issues or be on long-term opioids. The goal is to determine if this active approach accelerates recovery after surgery. As an unphased trial, this study allows participants to contribute to innovative recovery strategies that could improve post-surgical outcomes for future patients.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic opioids, you cannot participate in the trial.

What prior data suggests that this active recovery program is safe for post-surgery recovery?

Research has shown that enhanced recovery programs, like the one under study, can be safe and beneficial for patients after surgery. Studies indicate that these programs often result in fewer complications and shorter hospital stays, allowing patients to return home sooner and with fewer issues.

The active recovery program being tested includes specific exercises and walking goals. Although direct safety data for this exact program is not yet available, similar programs have been well-tolerated, suggesting it may be safe for most participants.

Everyone's recovery is unique. Prospective participants should discuss any concerns with their doctor before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Active Recovery program because it goes beyond standard post-surgery care by incorporating specific walking goals, abdominal strengthening exercises, and pelvic floor exercises. Unlike typical recovery plans that offer general instructions, this program provides structured physical activities aimed at enhancing recovery. The focus on active rehabilitation could potentially accelerate healing and improve overall outcomes for patients undergoing pelvic surgery.

What evidence suggests that this active recovery program is effective for post-surgery recovery?

Research has shown that active recovery programs, which participants in this trial may receive, can help patients heal faster after pelvic surgery. One study found that these programs significantly shortened hospital stays, allowing more patients to go home the same day as their surgery. Another study indicated that combining active recovery with certain surgical methods improved overall recovery. Enhanced recovery programs also reduce complications and lower healthcare costs. These findings suggest that active recovery programs could effectively speed up recovery after pelvic reconstructive surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Sara Cichowski, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-89 who are undergoing minimally invasive surgery for pelvic floor dysfunction at OHSU. Participants must be able to walk or be active for 30 minutes, not use chronic opioids or mobility aids like walkers, and must have email access.

Inclusion Criteria

I am having a minimally invasive surgery for pelvic organ prolapse at OHSU.

I have a reliable email for communication.

Exclusion Criteria

Unable to read and complete questionnaires in English

I am unable to give consent by myself.

I cannot walk or be active for 30 minutes without stopping.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pelvic reconstructive surgery followed by either standard postoperative care or an active recovery program

12 weeks

Follow-up

Participants are monitored for changes in pelvic floor function, quality of life, and mental health

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Recovery

Trial Overview The study compares the standard postoperative care with a new 'active recovery' program after pelvic reconstructive surgery. The goal is to evaluate if this new program improves recovery outcomes.

How Is the Trial Designed?

Group I: Standard of Care Active Control 1 Intervention

Participants will receive standard postoperative instructions only

Group II: Active Recovery Active Control 1 Intervention

Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05950633

NCT05950633 | Postoperative Active Recovery This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery. Detailed Description.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10532386/

Enhanced Recovery after Pelvic Organ Prolapse Surgery All the studies we reviewed exhibited significant reductions in their length of stay, with an increased proportion of day 0 discharges.

3. withpower.com withpower.com/trial/phase-pelvic-floor-disorders-7-2023-92091

Active Recovery Program for Post-Surgery ... This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery. Show more. Who Is on ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5329702/

Enhanced recovery after surgery: Current research insights ... Enhanced recovery after surgery (ERAS) together with laparoscopic surgery improves clinical outcomes in patients post-operatively.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820097

Enhanced Recovery After Surgery Guidelines and Hospital ... ERAS guidelines provide recommendations for perioperative care and have been found to reduce complications, length of hospital stay, and cost.

6. mdpi.com mdpi.com/2077-0383/12/18/5911

Enhanced Recovery after Pelvic Organ Prolapse Surgery All the studies we reviewed exhibited significant reductions in their length of stay, with an increased proportion of day 0 discharges.