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NCT00683098 Clinical Trial

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

Hernia Clinical Trial

Official title:
Long-term Results After Endoscopic Total Extraperitoneal Repair of Recurrent Inguinal Hernia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00683098
Other study ID # TEP Clara
Secondary ID
Status Completed
Phase N/A
First received May 21, 2008
Last updated April 15, 2016
Start date June 2008
Est. completion date December 2008

Study information
Verified date April 2016
Source St. Claraspital AG
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland St. Claraspital Basel

Sponsors (1)
Lead Sponsor Collaborator
St. Claraspital AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Fränneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyrén 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. — View Citation

Hallén 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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pain according to Inguinal Pain Questionnaire Activity according to Inguinal Pain Questionnaire up to 10 years No
Secondary Recurrence, Reoperation up to 10 years No
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