NCT02210416

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
968

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

August 5, 2014

Last Update Submit

October 11, 2015

Conditions

Inguinal HerniaComplication

Outcome Measures

Primary Outcomes (2)

  • cost of complication

    any complication associated with hernia surgery within 3 years, and its total costs

    3 years

  • cost of primary treatment

    the in-hospital costs of inguinal hernia repair surgery and the costs of convalescence following surgery

    2 months

Study Arms (2)

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

Interventions

inguinal hernia surgeryPROCEDURE
LAP repairopen repair

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • patients treated surgically for inguinal hernia between 2002-2011

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Karelia Central Hospital

Joensuu, FIN-80210, Finland

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 6, 2014

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

June 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

FI(1)