Inguinal Hernia Management: Watchful Waiting vs. Tension-Free Open Repair
Completed · Not applicable
Conditions studied: Inguinal Hernias
In brief
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.
Key facts
- Study ID
- NCT01922674
- Run by
- Creighton University
- People needed
- 720
- Starts
- 1999-01-01
- Expected to finish
- 2004-12-01
- Last updated by the study team
- 2018-04-04
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 18 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
Where it is running
- Creighton University — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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