NCT00263250

Brief Summary

This is a multicenter clinical trial to compare pain, physical function, and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernias randomly assigned to watchful waiting without an operation, or a standard hernia repair with mesh. We studied the safety of delaying operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
724

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2005

Completed
Last Updated

July 1, 2013

Status Verified

June 1, 2013

Enrollment Period

5.8 years

First QC Date

December 6, 2005

Last Update Submit

June 28, 2013

Conditions

Inguinal Hernia

Keywords

inguinal herniaasymptomaticwatchful waitingtension-free hernia repair

Outcome Measures

Primary Outcomes (2)

  • Pain limiting usual activities at two years.

  • Physical function (PCS) at two years.

Secondary Outcomes (3)

  • Complications

  • patient-reported outcomes of pain, functional status, activity levels, and satisfaction with care.

  • Cost effectiveness.

Interventions

watchful waiting or tension-free hernia repairPROCEDURE

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American College of Surgeons

Chicago, Illinois, 60610, United States

Location

Related Publications (5)

  • Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, Dunlop DD, Reda DJ, McCarthy M Jr, Neumayer LA, Barkun JS, Hoehn JL, Murphy JT, Sarosi GA Jr, Syme WC, Thompson JS, Wang J, Jonasson O. Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA. 2006 Jan 18;295(3):285-92. doi: 10.1001/jama.295.3.285.

    PMID: 16418463RESULT

  • Schroeder AD, Tubre DJ, Fitzgibbons RJ Jr. Watchful Waiting for Inguinal Hernia. Adv Surg. 2019 Sep;53:293-303. doi: 10.1016/j.yasu.2019.04.014. Epub 2019 May 15. No abstract available.

    PMID: 31327453DERIVED

  • Ramanan B, Maloley BJ, Fitzgibbons RJ Jr. Inguinal hernia: follow or repair? Adv Surg. 2014;48:1-11. doi: 10.1016/j.yasu.2014.05.017.

    PMID: 25293603DERIVED

  • Fitzgibbons RJ Jr, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013 Sep;258(3):508-15. doi: 10.1097/SLA.0b013e3182a19725.

    PMID: 24022443DERIVED

  • Sarosi GA, Wei Y, Gibbs JO, Reda DJ, McCarthy M, Fitzgibbons RJ, Barkun JS. A clinician's guide to patient selection for watchful waiting management of inguinal hernia. Ann Surg. 2011 Mar;253(3):605-10. doi: 10.1097/SLA.0b013e31820b04e9.

    PMID: 21239979DERIVED

Related Links

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Olga Jonasson, M.D.

    American College of Surgeons

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 6, 2005

First Posted

December 8, 2005

Study Start

February 1, 1999

Primary Completion

December 1, 2004

Study Completion

February 1, 2005

Last Updated

July 1, 2013

Record last verified: 2013-06

Locations

US(1)