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

Sponsored by:	St. Claraspital AG
Information provided by:	St. Claraspital AG
ClinicalTrials.gov Identifier:	NCT00683098

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

MedlinePlus related topics: Endoscopy Hernia

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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:

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 Apr 29; [Epub ahead of print]

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. Epub 2008 Jan 14.

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.

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

Keywords provided by St. Claraspital AG:

recurrent hernia
endoscopic total extraperitoneal repair
inguinal pain
questionnaire

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal

Pain
Hernia, Inguinal
Recurrence

ClinicalTrials.gov processed this record on January 16, 2009