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NCT04815707 · ClinicalTrials.gov registry record · Phase 2

Treatment of Occult Inguinal Hernias

A Phase 2 study of Inguinal Hernia, sponsored by The University of Texas Health Science Center, Houston.

Active
Registry status
Phase 2
Development phase
252
Enrollment target
2
Study locations

NCT04815707 is a Phase 2 study of Inguinal Hernia that is active but no longer recruiting, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 252 participants, below the 334-participant average among 11 other Inguinal Hernia trials with a reported enrollment target (25% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT04815707, a Phase 2 study of Inguinal Hernia, is active but no longer recruiting, sponsored by The University of Texas Health Science Center, Houston.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
252 participants
Enrollment target
2
Study locations

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.

Conditions Studied

Interventions

  • PROCEDURE Occcult hernia repair

Study Locations (2)

Texas

  • Lyndon B. Johnson General Hospital - Houston
  • Memorial Hermann Hospital-MIST Clinics - Houston

Trial Details

FieldValue
Enrollment Target 252 participants
Start Date 2021-10-22
Est. Completion 2026-10
Phase Phase 2

What the Registry Record Tells You About NCT04815707

The ClinicalTrials.gov registry entry for NCT04815707 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 334-participant average among 11 other Inguinal Hernia trials with a reported enrollment target (25% lower). The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Inguinal Hernia appearing as the primary indexed condition, and to 1 intervention - of which Occcult hernia repair is the first listed.

NCT04815707 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04815707 about?

NCT04815707 is a clinical study titled "Treatment of Occult Inguinal Hernias". 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 o...

What is the current status of trial NCT04815707?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 252 participants. The study started on 2021-10-22. Estimated completion is 2026-10.

What conditions does trial NCT04815707 study?

This clinical trial studies the following conditions: Inguinal Hernia.

What interventions are being tested in trial NCT04815707?

The interventions under investigation include: Occcult hernia repair (PROCEDURE).

Who is sponsoring clinical trial NCT04815707?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04815707 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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