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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: NA
Last verified: December 2012
History: No changes posted
  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 National Patient Insurance Association (NPIA) receives reports from surgical complications. In this study, the database of NPIA is used to compare the complication profiles of open and laparoscopic inguinal hernia surgery with mesh. In addition, a reference material of uncomplicated laparoscopic hernia procedures is collected from North Karelia Central Hospital to search for factors predisposing to severe laparoscopic complications.


Condition
Inguinal Hernia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration: 2 Years
Official Title: Complications in Inguinal Hernia Surgery - a Nationwide Registry Study

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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: 730
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, reference population of uncomplicated laparoscopic inguinal hernioplasties from North Karelia Central Hospital in 2002-2010.

Criteria

Inclusion Criteria:

  • surgery between 2002 and 2010
  • complicated inguinal hernia surgery reported to NPIA
  • uncomplicated laparoscopic inguinal hernia surgery in North Karelia Central Hospital

Exclusion Criteria:

  • none
  Contacts and Locations
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: December 31, 2012
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 May 22, 2013