Inguinal HerniaPhase 2NCT04815707
Treatment of Occult Inguinal Hernias
A Phase 2 study testing Occcult hernia repair in people with Inguinal Hernia, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
Inguinal hernias are a common surgical problem. Best management of occult inguinal hernias, defined as hernias unable to be felt on physical exam, is unknown. From prior studies we know that most inguinal hernias will eventually become symptomatic and require surgery (70%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Occcult hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2021to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have a contralateral occult inguinal hernia
Who cannot join
- Patient has life expectancy of less than 2 years
- Patients unlikely to follow-up (e.g. live out of state, unable to be reached by phone/e-mail
- Non-English and Non-Spanish speakers
- Pregnant or breast-feeding patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
Memorial Hermann Hospital-MIST Clinics
Houston, Texas, 77030
About this study
Official title: Surgical Repair Versus Expectant Management of Occult Inguinal Hernias: Strengthening the Evidence Base and Developing a Decision Tool
Inguinal hernias are a common surgical problem. Best management of occult inguinal hernias, defined as hernias unable to be felt on physical exam, is unknown. From prior studies we know that most inguinal hernias will eventually become symptomatic and require surgery (70%). However, doing a repair on a very small, occult hernia may open the patient up to surgical complications, like chronic pain, earlier than necessary. This will be a multi-center randomized controlled trial of surgical repair versus expectant management of occult inguinal hernias. Patients undergoing laparoscopic unilateral inguinal hernia repair will be included. At the time of surgery, the surgeon will determine if there is an occult hernia contralateral side. If present, patients will be randomized to repair of the occult side or expectant management of the occult side. After 1 year post-operative data has been assessed, a decision tool will be created and administered to patients to aid in their decision making about treatments for their hernia.
- Conditions
- Inguinal Hernia
- Being tested
- Occcult hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occcult hernia repairProcedure or surgery
The occult hernia will be repaired during the same inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | Occult hernia found will be repaired at the same time as the initial inguinal hernia Receives: Procedure: Occcult hernia repair |
| Expectant Management | No intervention | No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Assessed by using a decision tool (standard gamble method) that will be developed using information gathered at 1 year post-operative
Measured: From Baseline up to 2 years post-operative
Secondary outcomes (12)
Number of patients who develop any surgical complication
Includes: Wound complications (e.g. SSI, seroma, hematoma, wound dehiscence), complications with the mesh, and hospital readmissions
Measured: 30 days post-operative
Hernia recurrence
recurrence of hernia
Measured: 2 years post-operative
Operative re-intervention
Number of patients who had to have another surgery to repair their hernia
Measured: 1 years post-operative
Assessment of chronic pain
Pain assessed by a validated visual assessment score
Measured: 1 year post-operative
Progression of hernia signs or symptoms
Will be assessed by the physician during the 1 year post-operative abdominal exam visit
Measured: 1 year post-operative
Change in Abdominal wall quality of life (AW-QOL)
Hernia-related Quality of Life Survey (HerQLes) will be used to assess this. Consists of 12 statements that the patient will rate how much he/she agrees with each statement. They will rate each statement from 1 (Strongly Disagree) to 10 (strongly agree). These 12 ratings will be combined to form one score.
Measured: From Baseline up to 2 years post-operative
Number of patients with an occult inguinal hernia
Prevalence of patients found to have an occult inguinal hernia during their initial inguinal surgery
Measured: Time of surgery
Groin pain on occult hernia side
Pain assessed by a validated visual assessment score
Measured: 1 month and 1 year post-operative
Time duration for surgery
Assessed by looking at the total time for the surgery to repair the inguinal hernia(s)
Measured: Time of surgery
Time off work due to the hernia surgery
The amount of time (days) patients had to take time off from work for the hernia surgery
Measured: Baseline to 2 years post-operative
Time to resume normal activity from any hernia surgery
The amount of time (days) it took for patients to resume their normal activities following hernia surgery
Measured: Baseline to 2 years post-operative
Satisfaction with Decision Scale
A decision scale looking at risk vs. benefit of hernia surgery will be done with patients
Measured: Baseline to 2 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start22 Oct 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Julie Holihan, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815707
- Sponsor's protocol ID
- HSC-MS-20-1327
- Other IDs
- KL2TR003168
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Repair Versus Expectant Management of Occult Inguinal Hernias: Strengthening the Evidence Base and Developing a Decision Tool
- ClinicalTrials.gov ID
- NCT04815707
- Acronym / sponsor ID
- HSC-MS-20-1327
- Conditions
- Inguinal Hernia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 252 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inguinal hernias are a common surgical problem. Best management of occult inguinal hernias, defined as hernias unable to be felt on physical exam, is unknown. From prior studies we know that most inguinal hernias will eventually become symptomatic and require surgery (70%). However, doing a repair on a very small, occult hernia may open the patient up to surgical complications, like chronic pain, earlier than necessary. This will be a multi-center randomized controlled trial of surgical repair versus expectant management of occult inguinal hernias. Patients undergoing laparoscopic unilateral inguinal hernia repair will be included. At the time of surgery, the surgeon will determine if there is an occult hernia contralateral side. If present, patients will be randomized to repair of the occult side or expectant management of the occult side. After 1 year post-operative data has been assessed, a decision tool will be created and administered to patients to aid in their decision making about treatments for their hernia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Procedure: Occcult hernia repairOccult hernia found will be repaired at the same time as the initial inguinal hernia |
| Expectant Management | No intervention | –No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have a contralateral occult inguinal hernia
Key exclusion criteria (4 listed)
- Patient has life expectancy of less than 2 years
- Patients unlikely to follow-up (e.g. live out of state, unable to be reached by phone/e-mail
- Non-English and Non-Spanish speakers
- Pregnant or breast-feeding patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occcult hernia repairThe occult hernia will be repaired during the same inguinal hernia repair | Procedure or surgery | Surgery |
Primary outcome
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
Time frame: From Baseline up to 2 years post-operative
Assessed by using a decision tool (standard gamble method) that will be developed using information gathered at 1 year post-operative
12 secondary outcomes
Number of patients who develop any surgical complication
Time frame: 30 days post-operative
Hernia recurrence
Time frame: 2 years post-operative
Operative re-intervention
Time frame: 1 years post-operative
Assessment of chronic pain
Time frame: 1 year post-operative
Progression of hernia signs or symptoms
Time frame: 1 year post-operative
Change in Abdominal wall quality of life (AW-QOL)
Time frame: From Baseline up to 2 years post-operative
Number of patients with an occult inguinal hernia
Time frame: Time of surgery
Groin pain on occult hernia side
Time frame: 1 month and 1 year post-operative
Time duration for surgery
Time frame: Time of surgery
Time off work due to the hernia surgery
Time frame: Baseline to 2 years post-operative
Time to resume normal activity from any hernia surgery
Time frame: Baseline to 2 years post-operative
Satisfaction with Decision Scale
Time frame: Baseline to 2 years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Occcult hernia repair in people with Inguinal Hernia, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From Baseline up to 2 years post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.