NCT00683098

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

May 21, 2008

Last Update Submit

April 15, 2016

Conditions

Hernia

Keywords

recurrent herniaendoscopic total extraperitoneal repairinguinal painquestionnaire

Outcome Measures

Primary Outcomes (1)

  • Pain according to Inguinal Pain Questionnaire Activity according to Inguinal Pain Questionnaire

    up to 10 years

Secondary Outcomes (1)

  • Recurrence, Reoperation

    up to 10 years

Study Arms (1)

1

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Claraspital

Basel, 4019, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 18443875BACKGROUND

  • 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.

    PMID: 18291251BACKGROUND

  • 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.

    PMID: 18161900BACKGROUND

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Urs Pfefferkorn, MD

    Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Registrar

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 23, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2008

Study Completion

December 1, 2008

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

CH(1)