Predisposing Factors for Chronic Postherniotomy Pain

Chronic Postherniotomy Pain Clinical Trial

Official title:

Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649142
• Other study ID #: (KF) 01 294867
• Status: Completed
• Phase: N/A
• First received: March 28, 2008
• Last updated: January 20, 2009
• Start date: January 2007
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Postherniotomy Pain

Intervention

Procedure:
• Open sutured mesh repair
Open sutured mesh repair
• Laparoscopic mesh glue fixation
Laparoscopic mesh glue fixation

Locations

Country	Name	City	State
Denmark	Ambulatory Surgical Clinic, Hørshom Sygehus	Hørsholm
Germany	Marienhospital, Viszeralchirurgie	Stuttgart

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aesculap AG, Baxter Healthcare Corporation

Countries where clinical trial is conducted

Denmark,  Germany, 

References & Publications (1)

Aasvang E, Kehlet H. Surgical management of chronic pain after inguinal hernia repair. Br J Surg. 2005 Jul;92(7):795-801. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of chronic pain		6 months postoperatively	Yes
Secondary	Changes in sensory function		6 months	Yes
Secondary	Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors		6 months	No