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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
252
The occult hernia will be repaired during the same inguinal hernia repair
Lyndon B. Johnson General Hospital
Houston, Texas, United States
Memorial Hermann Hospital-MIST Clinics
Houston, Texas, United States
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
Time frame: From Baseline up to 2 years post-operative
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
Time frame: 30 days post-operative
Hernia recurrence
recurrence of hernia
Time frame: 2 years post-operative
Operative re-intervention
Number of patients who had to have another surgery to repair their hernia
Time frame: 1 years post-operative
Assessment of chronic pain
Pain assessed by a validated visual assessment score
Time frame: 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
Time frame: 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.
Time frame: 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 frame: Time of surgery
Groin pain on occult hernia side
Pain assessed by a validated visual assessment score
Time frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 2 years post-operative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.