Treatment of Occult Inguinal Hernias

Overview

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.

Full Title of Study: “Surgical Repair Versus Expectant Management of Occult Inguinal Hernias: Strengthening the Evidence Base and Developing a Decision Tool”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2023

Interventions

  • Procedure: Occcult hernia repair
    • The occult hernia will be repaired during the same inguinal hernia repair

Arms, Groups and Cohorts

  • Other: Surgery
    • Occult hernia found will be repaired at the same time as the initial inguinal hernia
  • No Intervention: Expectant Management
    • No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Number of patients who develop any surgical complication
    • Time Frame: 30 days post-operative
    • Includes: Wound complications (e.g. SSI, seroma, hematoma, wound dehiscence), complications with the mesh, and hospital readmissions
  • Hernia recurrence
    • Time Frame: 2 years post-operative
    • recurrence of hernia
  • Operative re-intervention
    • Time Frame: 1 years post-operative
    • Number of patients who had to have another surgery to repair their hernia
  • Assessment of chronic pain
    • Time Frame: 1 year post-operative
    • Pain assessed by a validated visual assessment score
  • Progression of hernia signs or symptoms
    • Time Frame: 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)
    • Time Frame: 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 Frame: Time of surgery
    • Prevalence of patients found to have an occult inguinal hernia during their initial inguinal surgery
  • Groin pain on occult hernia side
    • Time Frame: 1 month and 1 year post-operative
    • Pain assessed by a validated visual assessment score
  • Time duration for surgery
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Baseline to 2 years post-operative
    • The amount of time (days) it took for patients to resume their normal activities following hernia surgery
  • Satisfaction with Decision Scale
    • Time Frame: Baseline to 2 years post-operative
    • A decision scale looking at risk vs. benefit of hernia surgery will be done with patients

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julie Holihan, Assistant Professor of Surgery-Clinical – The University of Texas Health Science Center, Houston
  • Overall Contact(s)
    • Julie Holihan, MD, 713-500-7188, Julie.L.Holihan@uth.tmc.edu

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