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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR003168 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Other | Occult 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occcult hernia repair | Procedure | The occult hernia will be repaired during the same inguinal hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Baseline up to 2 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days post-operative |
| Hernia recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B. Johnson General Hospital | Houston | Texas | 77026 | United States | ||
| Memorial Hermann Hospital-MIST Clinics |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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recurrence of hernia
| 2 years post-operative |
| Operative re-intervention | Number of patients who had to have another surgery to repair their hernia | 1 years post-operative |
| Assessment of chronic pain | Pain assessed by a validated visual assessment score | 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 | 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. | 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 | Time of surgery |
| Groin pain on occult hernia side | Pain assessed by a validated visual assessment score | 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) | 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 | 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 | 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 | Baseline to 2 years post-operative |
| Houston |
| Texas |
| 77030 |
| United States |