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Local vs General Anesthesia for Inguinal Hernia Repair in Older Adults
N/A
Waitlist Available
Led By Courtney Balentine, MD, MPH
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >=65 years
Presenting to clinic with a unilateral inguinal hernia that is not incarcerated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, estimated 2 years
Awards & highlights
Study Summary
This trial aims to determine which type of anesthesia is best for hernia repair in older adults: general or local. It seeks to address unanswered questions about the effects of anesthetic technique on cognitive function and quality of life.
Who is the study for?
This trial is for people aged 65 or older with a unilateral inguinal hernia that hasn't been repaired before and isn't trapped. They must be fit for either general or local anesthesia, willing to follow the study plan for six months post-surgery, and speak English as their primary language.Check my eligibility
What is being tested?
The study compares outcomes of inguinal hernia surgery using different types of anesthesia: open repair under local anesthesia versus open repair or laparoscopic/robotic repair under general anesthesia in older adults.See study design
What are the potential side effects?
Local anesthesia may cause less cognitive and physical decline in older patients compared to general anesthesia, which carries risks like confusion, memory issues, longer recovery times, and potential complications from being unconscious.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
Select...
I have a one-sided groin hernia that isn't trapped.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, estimated 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, estimated 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participant satisfaction
Proportion of missing data
Proportion of participants completing all study visits
+2 moreSecondary outcome measures
Anesthesia time
Carolinas Comfort Scale
Delirium
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Open Inguinal Repair- Local anesthesiaExperimental Treatment1 Intervention
This arm will receive local anesthesia for their open inguinal hernia repair.
Group II: Inguinal Hernia Repair- General AnesthesiaActive Control1 Intervention
This arm will receive general anesthesia for their open inguinal hernia repair.
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Who is running the clinical trial?
American Federation for Aging ResearchOTHER
7 Previous Clinical Trials
1,918 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,845 Total Patients Enrolled
The John A. Hartford FoundationOTHER
17 Previous Clinical Trials
7,374 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a trapped or pinched hernia.I am 65 years old or older.I have a one-sided groin hernia that isn't trapped.I am willing to follow the study's requirements for six months after surgery.I need another surgery at the same time as my hernia repair.You are allergic to local anesthesia.I cannot have general anesthesia due to health reasons.I am considered fit for general or local anesthesia.My hernia has been repaired before.I do not have an infection that would prevent mesh use in hernia surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Open Inguinal Repair- Local anesthesia
- Group 2: Inguinal Hernia Repair- General Anesthesia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently room for more participants in this experiment?
"According to clinicaltrials.gov, this particular medical study is no longer welcoming applicants as the last edit was made on August 24th 2023. Despite its closure, 194 other trials are actively searching for participants in a variety of different locations throughout the world."
Answered by AI
What aim is this trial striving to achieve?
"This two-year clinical trial aims to measure the amount of participants that complete all study visits. Secondary objectives include evaluating quality of life through the Carolinas Comfort Scale (scores ranging from 1-6, with higher scores signifying better wellbeing), physical function using the 6 item Katz Index (scores range from 0-6; higher numbers indicate more autonomy) and cognitive function via a Trail Making Test (results are determined by completion time, those taking longer than expected being deemed deficient)."
Answered by AI
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