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No Lifting Restrictions After Inguinal Hernia Repair

N/A
Recruiting
Led By Edward Jones
Research Sponsored by VA Eastern Colorado Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks to compare outcomes of patients given physical activity restrictions post-surgery vs. those given the autonomy to return to activity. Outcomes include complications, hernia recurrence, activity levels, and quality of life.

Who is the study for?
This trial is for individuals with a clinical diagnosis of unilateral inguinal hernia who are scheduled for surgery and can provide consent. It's not suitable for those unable to follow the study procedures or give informed consent.
What is being tested?
The study tests if patients recovering from single-sided inguinal hernia surgery have better outcomes when they decide how soon to return to physical activity, compared to those following strict post-op lifting and activity restrictions.
What are the potential side effects?
Since this trial involves post-surgery behavior rather than medication, side effects may include potential complications from early physical activity such as pain, discomfort, or hernia recurrence.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Physiological parameter- Hernia recurrence
Physiological parameter- Postoperative Complications
Secondary study objectives
Questionnaire- Postoperative Activity levels

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Activity as toleratedExperimental Treatment1 Intervention
Instruction will be a treatment group "return to activity as tolerated/comfortable and stop activity if pain present".
Group II: Standard Lifting RestrictionsActive Control1 Intervention
Instructions will be "no lifting greater than 20lbs for 6 weeks for open surgery, 2 weeks for minimally invasive surgery".

Find a Location

Who is running the clinical trial?

VA Eastern Colorado Health Care SystemLead Sponsor
54 Previous Clinical Trials
26,018 Total Patients Enrolled
Edward JonesPrincipal InvestigatorVHAECH

Media Library

Activity as tolerated Clinical Trial Eligibility Overview. Trial Name: NCT05867134 — N/A
Inguinal Hernia Research Study Groups: Activity as tolerated, Standard Lifting Restrictions
Inguinal Hernia Clinical Trial 2023: Activity as tolerated Highlights & Side Effects. Trial Name: NCT05867134 — N/A
Activity as tolerated 2023 Treatment Timeline for Medical Study. Trial Name: NCT05867134 — N/A
~9 spots leftby Dec 2024
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