Complications in Inguinal Hernia Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanna Kouhia, North Karelia Central Hospital
ClinicalTrials.gov Identifier:
NCT01760395
First received: December 31, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition
Inguinal Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Complications in Inguinal Hernia Surgery - a Nationwide Registry Study

Resource links provided by NLM:


Further study details as provided by North Karelia Central Hospital:

Primary Outcome Measures:
  • surgical complication [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 335
Study Start Date: January 2002
Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT01760395     History of Changes
Other Study ID Numbers: NKCH-surg-010
Study First Received: December 31, 2012
Last Updated: August 5, 2014
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on September 18, 2014