Costs of Complications in Inguinal Hernia Repair

October 11, 2015 updated by: Sanna Kouhia, North Karelia Central Hospital
Laparoscopic inguinal hernia repair is becoming increasingly popular mainly because of short-term advantages compared to open hernioplasties with mesh. In the prevailing economic climate, the total costs of treatment is a subject of intense research. This study is designed to evaluate the results of open and laparoscopic inguinal hernia repairs, with a special emphasis in costs of treatment, complications and convalescence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

968

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Joensuu, Finland, FIN-80210
        • North Karelia Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing laparoscopic inguinal hernia repair (TAPP or TEP) during 2002-2011 A sample of 528 patients undergoing open flat mesh repair in 2002-2011.

Description

Inclusion Criteria:

  • patients treated surgically for inguinal hernia between 2002-2011

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LAP repair
patients receiving laparoscopic inguinal hernia repair
Procedure: inguinal hernia surgery
open repair
patients receiving open flat mesh repair of inguinal hernia
Procedure: inguinal hernia surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost of complication
Time Frame: 3 years
any complication associated with hernia surgery within 3 years, and its total costs
3 years
cost of primary treatment
Time Frame: 2 months
the in-hospital costs of inguinal hernia repair surgery and the costs of convalescence following surgery
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Karelia Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 11, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKCH-Surg-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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