- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00683098
Long-term Results After Endoscopic Total Extraperitoneal Repair of Recurrent Inguinal Hernia
April 15, 2016 updated by: Urs Pfefferkorn, St. Claraspital AG
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Basel, Switzerland, 4019
- St. Claraspital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- patients, who had endoscopic total extraperitoneal repair of recurrent inguinal hernia at our institution between 1995 and 2008
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
patients, who had a endoscopic total extraperitoneal repair of recurrent inguinal hernia between 1995 and 2008
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain according to Inguinal Pain Questionnaire Activity according to Inguinal Pain Questionnaire
Time Frame: up to 10 years
|
up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence, Reoperation
Time Frame: up to 10 years
|
up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Urs Pfefferkorn, MD, Department of Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. doi: 10.1002/bjs.6014.
- Staarink M, van Veen RN, Hop WC, Weidema WF. A 10-year follow-up study on endoscopic total extraperitoneal repair of primary and recurrent inguinal hernia. Surg Endosc. 2008 Aug;22(8):1803-6. doi: 10.1007/s00464-008-9917-9. Epub 2008 Apr 29.
- Hallen M, Bergenfelz A, Westerdahl J. Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: long-term follow-up of a randomized controlled trial. Surgery. 2008 Mar;143(3):313-7. doi: 10.1016/j.surg.2007.09.028. Epub 2008 Jan 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
May 21, 2008
First Submitted That Met QC Criteria
May 22, 2008
First Posted (Estimate)
May 23, 2008
Study Record Updates
Last Update Posted (Estimate)
April 18, 2016
Last Update Submitted That Met QC Criteria
April 15, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEP Clara
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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