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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Memorial Hermann Hospital-MIST Clinics
Houston, Texas 77030
Contact:
Julie Holihan, MD
713-500-7188
Julie.L.Holihan@uth.tmc.edu

Lyndon B. Johnson General Hospital
Houston, Texas 77026
Contact:
Julie Holihan, MD
713-500-7188
Julie.L.Holihan@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Julie Holihan, MD
713-500-7188
Julie.L.Holihan@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.