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

Tracking Information
First Received Date ^ICMJE	December 31, 2012
Last Updated Date	December 31, 2012
Start Date ^ICMJE	January 2002
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 31, 2012)	surgical complication [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Complications in Inguinal Hernia Surgery
Official Title ^ICMJE	Complications in Inguinal Hernia Surgery - a Nationwide Registry Study
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 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational [Patient Registry]
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Retrospective
Target Follow-Up Duration	2 Years
Biospecimen	Not Provided
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.
Condition ^ICMJE	Inguinal Hernia
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	730
Completion Date	December 2012
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01760395
Other Study ID Numbers ^ICMJE	NKCH-surg-010
Has Data Monitoring Committee	No
Responsible Party	Sanna Kouhia, North Karelia Central Hospital
Study Sponsor ^ICMJE	North Karelia Central Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	North Karelia Central Hospital
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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