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OpenTrials
Completed

NCT Number: NCT00649142

Predisposing Factors for Chronic Postherniotomy Pain

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.

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Key information

Conditions

Chronic Postherniotomy Pain Hernia Hernia, Abdominal Hernia, Inguinal Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ambulatory Surgical Clinic, Hørshom Sygehus, Hørsholm, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Neurological disease
  • Diabetes with late stage complications

Treatment and study plan

Open sutured mesh repair

Procedure

Open sutured mesh repair

Laparoscopic mesh glue fixation

Procedure

Laparoscopic mesh glue fixation

Primary outcomes

  1. Frequency of chronic pain

    Time frame: 6 months postoperatively

Secondary outcomes

  1. Changes in sensory function

    Time frame: 6 months

  2. Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aesculap AG
  • Baxter Healthcare Corporation

Registry information

Official study title

Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 1, 2008
Registry last updated
Jan 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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