Inguinal Hernia
Conditions
Brief 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%). 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.
Interventions
PROCEDUREOcccult hernia repair
The occult hernia will be repaired during the same inguinal hernia repair
Sponsors
The University of Texas Health Science Center, Houston
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have a contralateral occult inguinal hernia
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative re-intervention | 1 years post-operative | Number of patients who had to have another surgery to repair their hernia |
| Assessment of chronic pain | 1 year post-operative | Pain assessed by a validated visual assessment score |
| Number of patients who develop any surgical complication | 30 days post-operative | Includes: Wound complications (e.g. SSI, seroma, hematoma, wound dehiscence), complications with the mesh, and hospital readmissions |
| Hernia recurrence | 2 years post-operative | recurrence of hernia |
| Change in Abdominal wall quality of life (AW-QOL) | From Baseline up to 2 years post-operative | 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. |
| Number of patients with an occult inguinal hernia | Time of surgery | Prevalence of patients found to have an occult inguinal hernia during their initial inguinal surgery |
| Groin pain on occult hernia side | 1 month and 1 year post-operative | Pain assessed by a validated visual assessment score |
| Time duration for surgery | Time of surgery | Assessed by looking at the total time for the surgery to repair the inguinal hernia(s) |
| Time off work due to the hernia surgery | Baseline to 2 years post-operative | The amount of time (days) patients had to take time off from work for the hernia surgery |
| Time to resume normal activity from any hernia surgery | Baseline to 2 years post-operative | The amount of time (days) it took for patients to resume their normal activities following hernia surgery |
| Progression of hernia signs or symptoms | 1 year post-operative | Will be assessed by the physician during the 1 year post-operative abdominal exam visit |
| Satisfaction with Decision Scale | Baseline to 2 years post-operative | A decision scale looking at risk vs. benefit of hernia surgery will be done with patients |
Countries
United States
Outcome results
None listed