Inguinal HerniaNCT02210416
Costs of Complications in Inguinal Hernia Repair
An observational study of Inguinal Hernia and Complication, run by North Karelia Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Inguinal Hernia, Complication
- What is being tested?
- inguinal hernia surgery
- Type of treatment
- Surgery or procedure
- How many people
- 968 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2012to Jun 2015
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- patients treated surgically for inguinal hernia between 2002-2011
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inguinal Hernia, Complication
- Being tested
- inguinal hernia surgery
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inguinal hernia surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| LAP repair | patients receiving laparoscopic inguinal hernia repair Receives: Procedure: inguinal hernia surgery | |
| open repair | patients receiving open flat mesh repair of inguinal hernia Receives: Procedure: inguinal hernia surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost of complication
any complication associated with hernia surgery within 3 years, and its total costs
Measured: 3 years
cost of primary treatment
the in-hospital costs of inguinal hernia repair surgery and the costs of convalescence following surgery
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 968 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
- NCT02210416
- Sponsor's protocol ID
- NKCH-Surg-011
- Status last verified
- Oct 2015
- First submitted
- 5 Aug 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Costs of Complications in Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT02210416
- Acronym / sponsor ID
- NKCH-Surg-011
- Conditions
- Inguinal Hernia, Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 968 participants (actual)
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Aug 2014 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAP repair | – | Procedure: inguinal hernia surgerypatients receiving laparoscopic inguinal hernia repair |
| open repair | – | Procedure: inguinal hernia surgerypatients receiving open flat mesh repair of inguinal hernia |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients treated surgically for inguinal hernia between 2002-2011
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inguinal hernia surgery | Procedure or surgery | LAP repair, open repair |
Primary outcome
cost of complication
Time frame: 3 years
any complication associated with hernia surgery within 3 years, and its total costs
cost of primary treatment
Time frame: 2 months
the in-hospital costs of inguinal hernia repair surgery and the costs of convalescence following surgery
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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Complication, run by North Karelia Central Hospital at 1 site in Finland.
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 1 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.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
cost of complication (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.