NCT00649142CompletedNot Applicable
Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain
Rigshospitalet, Denmark2 sites in 2 countries455 target enrollmentStarted: January 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 455
- Locations
- 2
- Primary Endpoint
- Frequency of chronic pain
Study Overview
Brief Summary
Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair. However no prospective study has investigated potential predisposing factors for development of pain, including genetic, psychosocial and detailed neurophysiological assessment of surgical method.
The current study will assess the above factors in a prospective study.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (>18 years)
- •Primary unilateral groin hernia
- •Ability to use pain scales
Exclusion Criteria
- •Neurological disease
- •Diabetes with late stage complications
Arms & Interventions
A
Active Comparator
Open sutured mesh repair
Intervention: Open sutured mesh repair (Procedure)
B
Active Comparator
Laparoscopic mesh glue fixation
Intervention: Laparoscopic mesh glue fixation (Procedure)
Outcomes
Primary Outcomes
Frequency of chronic pain
Time Frame: 6 months postoperatively
Secondary Outcomes
- Changes in sensory function(6 months)
- Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors(6 months)
Investigators
Study Sites (2)
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