Complications in Inguinal Hernia Surgery

Inguinal Hernia Clinical Trial

Official title:

Complications in Inguinal Hernia Surgery - a Nationwide Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760395
• Other study ID #: NKCH-surg-010
• Status: Completed
• Phase: N/A
• First received: December 31, 2012
• Last updated: October 11, 2015
• Start date: January 2002
• Est. completion date: December 2012

Study information

• Verified date: October 2015
• Source: North Karelia Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 110 Years

Eligibility

Inclusion Criteria:

• surgery between 2002 and 2010

• complicated inguinal hernia surgery reported to FPIC

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Karelia Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical complication		2 years	Yes