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Inguinal Hernia Management: Watchful Waiting vs. Tension-Free Open Repair

NCT01922674 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2018-04-04

No results posted yet for this study

Summary

Purpose: To determine if observation (watchful waiting is a safe alternative to routine repair of asymptomatic inguinal hernias in adult males.

Scope: Traditionally surgeons are taught that all inguinal hernias should be repaired at diagnosis to prevent the life threatening complications of bowel obstruction or incarceration with strangulation and that operation becomes more difficult the longer a hernia is left un-repaired.

Conditions

  • Inguinal Hernias

Interventions

PROCEDURE

Standard open tension-free inguinal hernia repair with mesh

Sponsors & Collaborators

  • Edward Hines Jr. VA Hospital

    collaborator FED

  • Northwestern University

    collaborator OTHER

  • VA Salt Lake City Health Care System

    collaborator FED

  • Marshfield Clinic Research Foundation

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • University of Nebraska

    collaborator OTHER

  • Royal Victoria Hospital, Canada

    collaborator OTHER

  • American College of Surgeons

    collaborator OTHER

  • Creighton University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-01-31
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01922674 on ClinicalTrials.gov