Treatment of Occult Inguinal Hernias

The University of Texas System (UT)

Status and phase: Active, not recruiting; Phase 2

Conditions: Inguinal Hernia

Treatments: Procedure: Occcult hernia repair

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04815707

KL2TR003168 (U.S. NIH Grant/Contract)

HSC-MS-20-1327

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 2 patient groups

Surgery

Other group

Description:

Occult hernia found will be repaired at the same time as the initial inguinal hernia

Treatment:

Procedure: Occcult hernia repair

Expectant Management

No Intervention group

Description:

No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery