RECRUITING

A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults

Talk to us

Conditions

Inguinal HerniaAnesthesia, LocalElderlyOutcomeLocal anesthesia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults

Quick Facts

Study Start:2024-10-23
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04706026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than or equal to 60 years
  2. * Presenting to clinic with a unilateral inguinal hernia that is not incarcerated
  3. * Considered suitable for either general or local anesthesia
  4. * Willing to complete all study requirements, including follow-up continuing until six months after surgery
  5. * English speaking
  1. * The hernia that the patient is being evaluated for has undergone prior repair
  2. * Any contraindications to general anesthesia
  3. * Allergies to local anesthesia
  4. * Evidence of hernia incarceration or strangulation
  5. * Active local or systemic infection that would preclude the use of mesh for hernia repair
  6. * Need for concurrent surgical repair at the time of hernia repair
  7. * English is not the patient's primary language
  8. * Enrollment in other research studies
  9. * Clinical judgement of surgeon or anesthesiology
  10. * Current pregnancy
  11. * Unwilling to provide consent
  12. * Current active illegal drug use
  13. * Current alcoholism
  14. * Claustrophobia
  15. * Unable to tolerate lying in supine position for greater than 30 minutes

Contacts and Locations

Study Contact

Anusha Talwalkar, MPH
CONTACT
608-265-9144
talwalkar@wisc.edu
Benjamin Cher, MD, MS
CONTACT
608-263-7502
bcher@wisc.edu

Principal Investigator

Courtney Balentine, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Courtney Balentine, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-23
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2024-10-23
Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

  • Elderly
  • Outcome
  • Inguinal hernia
  • Local anesthesia

Additional Relevant MeSH Terms

  • Inguinal Hernia
  • Anesthesia, Local