Predisposing Factors for Chronic Postherniotomy Pain

Not Applicable

Completed

• Conditions: Chronic Postherniotomy Pain
• Interventions: Procedure: Open sutured mesh repair; Procedure: Laparoscopic mesh glue fixation

• Registration Number: NCT00649142
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 455

Inclusion Criteria

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

Exclusion Criteria

• Neurological disease
• Diabetes with late stage complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Open sutured mesh repair	Open sutured mesh repair
B	Laparoscopic mesh glue fixation	Laparoscopic mesh glue fixation

Primary Outcome Measures

Name	Time	Method
Frequency of chronic pain	6 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Changes in sensory function	6 months
Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors	6 months

Trial Locations

Locations (2)

Marienhospital, Viszeralchirurgie; 🇩🇪 Stuttgart, Germany

Ambulatory Surgical Clinic, Hørshom Sygehus; 🇩🇰 Hørsholm, Denmark