NCT02424604

Brief Summary

Aim The overall aim with this study is to improve outcome after inguinal hernia repair (IHR). It is not known today if a re-operation due to recurrence after bi-layer mesh IHR is more complicated than compared with the golden standard method. Method This project is a registry study. The National hernia register (Svenskt bråckregister, SBR) which started in 1992 include data that cover nearly 100% of all the country's hernia operations. Patient data are collected from SBR. Patients who at the time of surgery were between 18-75 years of age and operated on due to primary inguinal hernia with any of the two mentioned techniques between 1992-2012 are eligible

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

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

April 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

April 7, 2015

Last Update Submit

March 10, 2017

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Number of recurrence

    Recurrence rate for BLM in Inguinal hernia surgery

    up to 30 days after surgery

Secondary Outcomes (1)

  • Number of surgical methods (BML and Lichtenstein)

    up to 30 days after surgery

Other Outcomes (2)

  • Minutes, time of surgery

    up to 30 days after surgery

  • Number of complications

    up to 30 days after surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patinets with relapse after inguinal hernia surgery

You may qualify if:

  • all patients in a national registry "inguinal hernia" who had had a relapse after inguinal surgery between 1992-2012

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ersta Hospital

Stockholm, 116 91, Sweden

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jesper Magnusson, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 23, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 13, 2017

Record last verified: 2016-03

Locations

SE(1)