Treatment of Occult Inguinal Hernias

Surgical Repair Versus Expectant Management of Occult Inguinal Hernias: Strengthening the Evidence Base and Developing a Decision Tool

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 Overview

• Status: Active, not recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Occcult hernia repair

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77026
      • Lyndon B. Johnson General Hospital
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital-MIST Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Surgery; Occult hernia found will be repaired at the same time as the initial inguinal hernia	Procedure: Occcult hernia repair; The occult hernia will be repaired during the same inguinal hernia repair
No Intervention: Expectant Management; No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Center for Advancing Translational Sciences (NCATS)

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Inguinal
• Other Study ID Numbers: HSC-MS-20-1327; KL2TR003168 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No