Treatment of Occult Inguinal Hernias

Last updated: December 5, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hernia

Treatment

Occcult hernia repair

Clinical Study ID

NCT04815707
HSC-MS-20-1327
KL2TR003168
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 or older

  • Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have acontralateral occult inguinal hernia

Exclusion

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 byphone/e-mail

  • Non-English and Non-Spanish speakers

  • Pregnant or breast-feeding patients

Study Design

Total Participants: 252
Treatment Group(s): 1
Primary Treatment: Occcult hernia repair
Phase: 2
Study Start date:
October 22, 2021
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Lyndon B. Johnson General Hospital

    Houston, Texas 77026
    United States

    Site Not Available

  • Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Memorial Hermann Hospital-MIST Clinics

    Houston, Texas 77030
    United States

    Site Not Available

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