Inguinal HerniaNCT01760395
Complications in Inguinal Hernia Surgery
An observational study of Inguinal Hernia, run by North Karelia Central Hospital.
Trial 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 Finnish Patient Insurance Centre (FPIC) receives reports from surgical complications. Read more about this study
- Who is it for?
- Ages 16 to 110 years
- Conditions the study is for
- Inguinal Hernia
- How many people
- 335 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Finnish patients having had complicated inguinal hernia surgery 2002-2010.
Who may be able to join
- surgery between 2002 and 2010
- complicated inguinal hernia surgery reported to FPIC
Who cannot join
- none
About this study
Official title: Complications in Inguinal Hernia Surgery - a Nationwide Registry Study
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 Finnish Patient Insurance Centre (FPIC) receives reports from surgical complications. In this study, the database of FPIC is used to compare the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.
- Conditions
- Inguinal Hernia
- Medical subject headings
- Hernia, Inguinal
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical complication
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2002
- Primary completionDec 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Karelia Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanna Kouhia, North Karelia Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760395
- Sponsor's protocol ID
- NKCH-surg-010
- Status last verified
- Oct 2015
- First submitted
- 31 Dec 2012
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kouhia S, Vironen J, Hakala T, Paajanen H. Open Mesh Repair for Inguinal Hernia is Safer than Laparoscopic Repair or Open Non-mesh Repair: A Nationwide Registry Study of Complications. World J Surg. 2015 Aug;39(8):1878-84; discussion 1885-6. doi: 10.1007/s00268-015-3028-2.
PubMed 25762240
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications in Inguinal Hernia Surgery - a Nationwide Registry Study
- ClinicalTrials.gov ID
- NCT01760395
- Acronym / sponsor ID
- NKCH-surg-010
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Finnish Patient Insurance Centre (FPIC) receives reports from surgical complications. In this study, the database of FPIC is used to compare the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Finnish patients having had complicated inguinal hernia surgery 2002-2010.
Key inclusion criteria (2 listed)
- surgery between 2002 and 2010
- complicated inguinal hernia surgery reported to FPIC
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
surgical complication
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Derived from this study: PubMed 25762240Kouhia S, Vironen J, Hakala T, Paajanen H. Open Mesh Repair for Inguinal Hernia is Safer than Laparoscopic Repair or Open Non-mesh Repair: A Nationwide Registry Study of Complications. World J Surg. 2015 Aug;39(8):1878-84; discussion 1885-6. doi: 10.1007/s00268-015-3028-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by North Karelia Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical complication (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01760395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.