Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00263250
First received: December 6, 2005
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Inguinal Hernia
Procedure: watchful waiting or tension-free hernia repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Pain limiting usual activities at two years.
  • Physical function (PCS) at two years.

Secondary Outcome Measures:
  • Complications
  • patient-reported outcomes of pain, functional status, activity levels, and satisfaction with care.
  • Cost effectiveness.

Estimated Enrollment: 724
Study Start Date: February 1999
Study Completion Date: February 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Detailed Description:

CONTEXT Many men with an inguinal hernia have minimal symptoms. Whether deferring operation is safe and a good option for some patients has not been assessed.

OBJECTIVE To compare pain and the Physical Component Score (PCS) of the SF-36 at two years in men with minimally symptomatic inguinal hernias randomized to watchful waiting (WW) or a standard tension-free hernia repair (TFR).

DESIGN, SETTING, AND PATIENTS. Between January, 1999 and December, 2004 we conducted a multicenter trial of 720 men (364 WW, 356 TFR) who were followed for 2-4.5 years. Men were excluded with hernia pain interfering with activities; undetectable hernias; infection; American Society of Anesthesiologists Physical Status >3; recent difficulty in reducing the hernia.

INTERVENTIONS Men assigned to WW were followed at 6 months and annually and watched for hernia symptoms. Men assigned to operation received TFR, and were followed at 3 and 6 months, and annually.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: men 18 years of age and older with asymptomatic or minimally symptomatic inguinal hernias who give informed consent to be randomized.

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Exclusion Criteria:Presence of pain limiting usual activities, difficulty in reducing hernia within last 6 weeks, undetectable hernias, local or systemic infection, ASA physical status >3, or participation in another clinical trial.

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00263250

Locations
United States, Illinois
American College of Surgeons
Chicago, Illinois, United States, 60610
Sponsors and Collaborators
Creighton University
Investigators
Study Director: Olga Jonasson, M.D. American College of Surgeons
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00263250     History of Changes
Other Study ID Numbers: RO1 HS 09860
Study First Received: December 6, 2005
Last Updated: June 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Creighton University:
inguinal hernia
asymptomatic
watchful waiting
tension-free hernia repair

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 21, 2014