A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults (NCT04706026) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
United States18 participantsStarted 2024-10-23
Plain-language summary
The purpose of this study is to collect data about local versus general anesthesia for inguinal hernia repair in Veterans aged 60 years for planning a larger, multisite randomized clinical trial. Approximately 80 participants will be enrolled and can expect to be on study for 6 months.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age greater than or equal to 60 years
* Presenting to clinic with a unilateral inguinal hernia that is not incarcerated
* Considered suitable for either general or local anesthesia
* Willing to complete all study requirements, including follow-up continuing until six months after surgery
* English speaking
Exclusion Criteria:
* The hernia that the patient is being evaluated for has undergone prior repair
* Any contraindications to general anesthesia
* Allergies to local anesthesia
* Evidence of hernia incarceration or strangulation
* Active local or systemic infection that would preclude the use of mesh for hernia repair
* Need for concurrent surgical repair at the time of hernia repair
* English is not the patient's primary language
* Enrollment in other research studies
* Clinical judgement of surgeon or anesthesiology
* Current pregnancy
* Unwilling to provide consent
* Current active illegal drug use
* Current alcoholism
* Claustrophobia
* Unable to tolerate lying in supine position for greater than 30 minutes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rates of enrollment and percentage of eligible patients enrolled
Timeframe: Through study completion, estimated 2 years
2
Proportion of participants completing all study visits
Timeframe: Through study completion, estimated 2 years
3
Proportion of missing data
Timeframe: Through study completion, estimated 2 years
4
Time to complete study evaluations and instruments
Timeframe: Time from beginning to end of completing study instrument, up to 2 hours
5
Participant satisfaction
Timeframe: At 6 month follow up
6
Whether Survey Instruments Can Be Eliminated due to Redundancy measured by R2 greater than 40%
Timeframe: measured at 25 percent of planned enrollment and 75 percent of planned enrollment, estimated to be up to 1.5 years
7
Estimate sample size for fully powered randomized trial