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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

Study 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.Check my eligibility
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.See study design
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

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

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
53 Previous Clinical Trials
25,978 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients being enrolled for this experiment?

"This trial requires that participants are aged 18 to 99. However, there is a total of 16 studies for minors and 136 clinical trials for seniors."

Answered by AI

Am I a viable candidate to join this experiment?

"Eligibility criteria for this clinical trial requires participants to have an inguinal hernia and be between 18-99 years of age. The study is looking to recruit around 200 people in total."

Answered by AI

Has enrollment for this experiment opened yet?

"Indeed, clinicaltrials.gov's information indicates that this trial is currently recruiting participants. It was originally posted on January 30th 2023 and recently modified on May 16th 2023. The study requires the enrollment of 200 individuals at a single site."

Answered by AI

What is the current intake capacity of this trial?

"That is correct. Per information on clinicaltrials.gov, this trial opened for enrollment on January 30th 2021 and is still recruiting participants as of May 16th 2021. The study seeks 200 patients from a single location."

Answered by AI

Who else is applying?

What site did they apply to?
Rocky Mountain Regional VA Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~70 spots leftby Dec 2024