NCT01760395

Brief Summary

Inguinal hernia repair is the most common procedure in general surgery. Even with acceptable complication rates, thousands of patients worldwide suffer from inguinal hernia surgery complications every year. In Finland, the Finnish Patient Insurance Centre (FPIC) receives reports from surgical complications. In this study, the database of FPIC is used to compare the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
335

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2002

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

8.9 years

First QC Date

December 31, 2012

Last Update Submit

October 11, 2015

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • surgical complication

    2 years

Eligibility Criteria

Age16 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Finnish patients having had complicated inguinal hernia surgery 2002-2010.

You may qualify if:

  • surgery between 2002 and 2010
  • complicated inguinal hernia surgery reported to FPIC

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kouhia S, Vironen J, Hakala T, Paajanen H. Open Mesh Repair for Inguinal Hernia is Safer than Laparoscopic Repair or Open Non-mesh Repair: A Nationwide Registry Study of Complications. World J Surg. 2015 Aug;39(8):1878-84; discussion 1885-6. doi: 10.1007/s00268-015-3028-2.

    PMID: 25762240DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 31, 2012

First Posted

January 4, 2013

Study Start

January 1, 2002

Primary Completion

December 1, 2010

Study Completion

December 1, 2012

Last Updated

October 14, 2015

Record last verified: 2015-10