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Treatment of Occult Inguinal Hernias

NCT ID: NCT04815707

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-22

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Surgery

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

Group Type OTHER

Occcult hernia repair

Intervention Type PROCEDURE

The occult hernia will be repaired during the same inguinal hernia repair

Expectant Management

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Occcult hernia repair

The occult hernia will be repaired during the same inguinal hernia repair

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Julie Holihan

Assistant Professor of Surgery-Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lyndon B. Johnson General Hospital

Houston, Texas, United States

Site Status

Memorial Hermann Hospital-MIST Clinics

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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KL2TR003168

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-20-1327

Identifier Type: -

Identifier Source: org_study_id