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Procedure
Occult Hernia Repair for Inguinal Hernia
Phase 2
Recruiting
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have a contralateral occult inguinal hernia
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-operative
Awards & highlights
Study Summary
This trial will study whether it is better to fix an inguinal hernia when it is found during surgery for another hernia, or to wait and see if it becomes symptomatic.
Who is the study for?
This trial is for adults over 18 who are already having laparoscopic surgery for an inguinal hernia and are found to have a hidden (occult) hernia on the other side. It's not for those unlikely to follow up, non-English or Spanish speakers, pregnant or breastfeeding individuals, or patients with a life expectancy of less than 2 years.Check my eligibility
What is being tested?
The study compares immediate surgical repair versus waiting and watching in managing small, undetectable inguinal hernias found during surgery. Participants will be randomly assigned to either get their occult hernia repaired right away or monitored without immediate repair.See study design
What are the potential side effects?
Potential side effects include typical surgical risks such as chronic pain at the site of the operation. Since some hernias may not cause symptoms immediately, early surgery could lead to experiencing these side effects sooner.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having laparoscopic surgery for a hernia and they found another hernia on the opposite side.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post-operative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient threshold value for need for future surgery in order to accept Expectant Management (EM) of an Occult Inguinal Hernia (OIH) determined using standard gamble technique
Secondary outcome measures
Assessment of chronic pain
Change in Abdominal wall quality of life (AW-QOL)
Groin pain on occult hernia side
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SurgeryExperimental Treatment1 Intervention
Occult hernia found will be repaired at the same time as the initial inguinal hernia
Group II: Expectant ManagementActive Control1 Intervention
No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,697 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
320 Previous Clinical Trials
401,450 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant or currently breastfeeding.I am having laparoscopic surgery for a hernia and they found another hernia on the opposite side.I do not speak English or Spanish.I am 18 years old or older.Your doctor thinks you may not live for more than 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Expectant Management
- Group 2: Surgery
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 this experiment still recruiting participants?
"According to the clinicaltrials.gov records, this particular medical trial is currently not recruiting any new participants; it was first posted in August 2021 and most recently updated in May of the same year. Nevertheless, there are 164 other experiments that are still inviting patients to join their studies."
Answered by AI
Does this intervention possess the necessary regulatory authorization?
"Due to the lack of evidence supporting efficacy, this treatment was assigned a safety score of 2. Nevertheless, there is some data that demonstrates its security."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Lyndon B. Johnson General Hospital
Memorial Hermann Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have a hernia which needs surgery. Can you help me or do you know someone who can?
PatientReceived 2+ prior treatments
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