Predisposing Factors for Chronic Postherniotomy Pain

Rigshospitalet

Status: Completed

Conditions: Chronic Postherniotomy Pain

Treatments: Procedure: Open sutured mesh repair; Procedure: Laparoscopic mesh glue fixation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00649142

(KF) 01 294867

Details and patient eligibility

About

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.

Enrollment: 455 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Neurological disease
• Diabetes with late stage complications

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

455 participants in 2 patient groups

A

Active Comparator group

Description:

Open sutured mesh repair

Treatment:

Procedure: Open sutured mesh repair

B

Active Comparator group

Description:

Laparoscopic mesh glue fixation

Treatment:

Procedure: Laparoscopic mesh glue fixation