NCT01922674

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

5.9 years

First QC Date

August 12, 2013

Last Update Submit

April 3, 2018

Conditions

Inguinal Hernias

Outcome Measures

Primary Outcomes (2)

  • Pain

    Pain or discomfort interfering with usual activities two years after enrollment

    2 years

  • Post operative complications

    Post-operative complications were assessed at the two-week visit and as needed for three months. Long-term complications, including hernia recurrence were assessed at the six-month and annual visits. Life-threatening complications were defined prior to the start of the study and were assessed up to 30 days postoperative.

    2 years

Secondary Outcomes (1)

  • Complications

    2 years

Study Arms (2)

Watchful Waiting

NO INTERVENTION

Assess pain, physical function, and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernia that do not have surgery

Standard open tension-free inguinal hernia repair with mesh

ACTIVE COMPARATOR

Assess pain, physical function, and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernia that undergo a standard open tension-free repair with mesh.

Procedure: Standard open tension-free inguinal hernia repair with mesh

Interventions

Standard open tension-free inguinal hernia repair with meshPROCEDURE
Standard open tension-free inguinal hernia repair with mesh

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older (19 years in Nebraska)
  • Male
  • Diagnosis of inguinal hernia (patients with bilateral and recurrent hernias are eligible)
  • Inguinal hernia that is either completely asymptomatic or minimally symptomatic (does not interfere with normal activities
  • Informed consent for randomization

You may not qualify if:

  • A hernia that could not detected on physical examination
  • American Society of Anesthesia (ASA) Class IV or V
  • Evidence was present of an acute hernia complication such as bowel obstruction, strangulation, peritonitis, or perforation
  • Local or systemic infection
  • Presence of pain and discomfort associated with the hernia that limits usual activities
  • A history of recent (within six weeks of visit) onset of difficulty in reducing a hernia that was previously easily reduced
  • Participation in another clinical trial
  • Female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 14, 2013

Study Start

January 1, 1999

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

April 4, 2018

Record last verified: 2018-04

Locations

US(1)