Treatment of Occult Inguinal Hernias
- Conditions
- Inguinal Hernia
- Interventions
- Procedure: Occcult hernia repair
- Registration Number
- NCT04815707
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 252
- Age 18 or older
- Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have a contralateral occult inguinal hernia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery Occcult hernia repair Occult hernia found will be repaired at the same time as the initial inguinal hernia
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Hernia recurrence 2 years post-operative recurrence of hernia
Operative re-intervention 1 years post-operative Number of patients who had to have another surgery to repair their hernia
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
Assessment of chronic pain 1 year post-operative Pain assessed by a validated visual assessment score
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
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
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
Groin pain on occult hernia side 1 month and 1 year post-operative Pain assessed by a validated visual assessment score
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
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
Trial Locations
- Locations (2)
Lyndon B. Johnson General Hospital
🇺🇸Houston, Texas, United States
Memorial Hermann Hospital-MIST Clinics
🇺🇸Houston, Texas, United States