Clinical Trials Logo
  1. Home
  2. Chronic Pain
  3. NCT01070693
  4. Details
NCT01070693 Clinical Trial

Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair

Chronic Pain Clinical Trial

Official title:
Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01070693
Other study ID # TYH1333
Secondary ID
Status Completed
Phase N/A
First received February 17, 2010
Last updated December 2, 2013
Start date September 2001
Est. completion date December 2009

Study information
Verified date December 2013
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Data Protection BoardFinland: Ethics CommitteeFinland: Finnish Medicines AgencyFinland: Ministry of Social Affairs and HealthFinland: National Advisory Board on Health Care Ethics
Study type Interventional

Clinical Trial Summary

This randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 2009
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Uni- or bilateral

- Primary or recurrent

Exclusion Criteria:

- body-mass index over 40kg/m2, severe co-morbidities

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Open mesh inguinal hernia repair
Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique
Device:
• Prolene Hernia System
Prolene Hernia System
Procedure:
• Lichtenstein technique
Lichtenstein technique

Locations
Country Name City State
Finland Helsinki University Central Hospital Espoo

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term Sequelae Any pain at five years 5 years No
See also
  Status Clinical Trial Phase
Completed NCT01659073 - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation N/A
Recruiting NCT05914311 - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration N/A
Recruiting NCT05422456 - The Turkish Version of Functional Disability Inventory
Enrolling by invitation NCT05422443 - The Turkish Version of Pain Coping Questionnaire
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04385030 - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury N/A
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05103319 - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed NCT03687762 - Back on Track to Healthy Living Study N/A
Completed NCT04171336 - Animal-assisted Therapy for Children and Adolescents With Chronic Pain N/A
Completed NCT03179475 - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury Phase 4
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Recruiting NCT06060028 - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Terminated NCT03538444 - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder N/A
Not yet recruiting NCT05812703 - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain