BridgeMD
New treatment option for Inguinal Hernia
Official title A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
ClinicalTrials.gov ID: NCT04706026
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States; Houston, Texas, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.