Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Long-Term Results After Endoscopic Total Extraperitoneal Repair of Recurrent Inguinal Hernia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
St. Claraspital AG
ClinicalTrials.gov Identifier:
NCT00683098
First received: May 21, 2008
Last updated: June 12, 2008
Last verified: June 2008
  Purpose

Evaluation of long-term results for chronic pain and impairment of daily activities after endoscopic total extraperitoneal repair of recurrent inguinal hernia with inguinal pain questionnaire (IPQ).


Condition
Hernia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-Term Results After Endoscopic Total Extraperitoneal Repair of Recurrent Inguinal Hernia

Resource links provided by NLM:


Further study details as provided by St. Claraspital AG:

Primary Outcome Measures:
  • Pain according to Inguinal Pain Questionnaire Activity according to Inguinal Pain Questionnaire [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence, Reoperation [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients, who had a endoscopic total extraperitoneal repair of recurrent inguinal hernia between 1995 and 2008

Detailed Description:

Evaluation of long-term results for chronic pain and impairment of daily activities after endoscopic total extraperitoneal repair of recurrent inguinal hernia with inguinal pain questionnaire (IPQ).

All patients, who had a endoscopic preperitoneal mesh repair of a recurrent inguinal hernia between 1995 and 2008 were prospectively recorded and will be sent the IPQ via mail.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients, who had endoscopic total extraperitoneal repair of recurrent inguinal hernia at our institution between 1995 and 2008

Criteria

Inclusion Criteria:

  • patients, who had endoscopic total extraperitoneal repair of recurrent inguinal hernia at our institution between 1995 and 2008

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683098

Locations
Switzerland
St. Claraspital
Basel, Switzerland, 4019
Sponsors and Collaborators
St. Claraspital AG
Investigators
Principal Investigator: Urs Pfefferkorn, MD Department of Surgery
  More Information

Publications:
Responsible Party: Urs Pfefferkorn MD, General Surgery
ClinicalTrials.gov Identifier: NCT00683098     History of Changes
Other Study ID Numbers: TEP Clara
Study First Received: May 21, 2008
Last Updated: June 12, 2008
Health Authority: Switzerland: Ethikkommission

Keywords provided by St. Claraspital AG:
recurrent hernia
endoscopic total extraperitoneal repair
inguinal pain
questionnaire

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 24, 2014