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Predisposing Factors for Chronic Postherniotomy Pain

Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00649142
Enrollment
455
Registered
2008-04-01
Start date
2007-01-31
Completion date
2008-09-30
Last updated
2009-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Postherniotomy Pain

Keywords

Groin hernia, Chronic postsurgical pain, open mesh repair, laparoscopic mesh glue fixation, Sensory changes after groin hernia repair

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.

Interventions

PROCEDUREOpen sutured mesh repair

Open sutured mesh repair

PROCEDURELaparoscopic mesh glue fixation

Laparoscopic mesh glue fixation

Sponsors

Aesculap AG
CollaboratorINDUSTRY
Baxter Healthcare Corporation
CollaboratorINDUSTRY
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Adult (\>18 years) * Male * Primary unilateral groin hernia * Ability to use pain scales

Exclusion criteria

* Neurological disease * Diabetes with late stage complications

Design outcomes

Primary

MeasureTime frame
Frequency of chronic pain6 months postoperatively

Secondary

MeasureTime frame
Changes in sensory function6 months
Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors6 months

Countries

Denmark, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026