Ventral Hernia MidlineABSNOMENCT01635868
The Effect of Sutures Versus Mesh in Umbilical Hernia Repair
An observational study of Ventral Hernia Midline, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Background Mesh repair reduces the risk of reoperation for recurrence in patients with small umbilical and epigastric hernias compared with sutured repair. However, reoperation for recurrence underestimates total recurrence (reoperation or clinical) and mesh reinforcement may induce chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia Midline
- How many people
- 1,313 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to Oct 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patient having mesh or sutured repair of small (> 2 cm) umbilical or epigastric hernias in the region of Zealand from 1th of January 2008 to 31th of December 2010.
Who may be able to join
- elective open mesh or sutured repair of small umbilical or epigastric hernia repairs
Who cannot join
- acute operation
- operation outside region of Zealand
- laparoscopic repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.
Background Mesh repair reduces the risk of reoperation for recurrence in patients with small umbilical and epigastric hernias compared with sutured repair. However, reoperation for recurrence underestimates total recurrence (reoperation or clinical) and mesh reinforcement may induce chronic pain. This study investigated the cumulated risk of recurrence after open mesh and sutured repair in small (≤2 cm) umbilical and epigastric hernias. Possible risk factors were evaluated for chronic pain and recurrence.
Methods A cohort study with questionnaire-follow-up was conducted. Patients with primary, elective, open mesh or sutured repair for a small umbilical or epigastric hernia (≤2 cm) were included. Follow-up was performed by a validated questionnaire regarding suspicion of recurrence and chronic pain (moderate or severe). Suspected recurrence qualified for clinical examination. Recurrence was defined as reoperation for recurrence or clinical recurrence. Risk factors for recurrence and chronic pain were investigated by multivariate analyses.
Read more
Results
1 313 patients completed the questionnaire and/or clinical follow-up (83 % response rate) and follow-up time was median 40 months (range 0-66 months). The total cumulated recurrence rate 55 months after primary repair was 10 % for mesh repair and 21 % for sutured repair (P=0.001). The incidence of chronic pain was 6 % after mesh repair and 5 % after sutured repair (P = 0.711). Recurrence was the only independent risk factor for chronic pain (P<0.001).
Conclusion Mesh repair halved the long-term risk of recurrence after repair for small umbilical and epigastric hernias without increased risk of chronic pain.
- Conditions
- Ventral Hernia Midline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| umbilical hernia repair | patients having umbilical or epigastric hernia repair from 2008-2010 in Zealand |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence (clinical or reoperation for recurrence)
follow-up time will be from 3-5 years
Measured: 3 years
Secondary outcomes (1)
chronic pain
patient self-registration on VRS. Moderate or severe pain is regarded as chronic pain
Measured: 3-5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral Hernia MidlineStudies 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
- Prospective
- Enrolment
- 1,313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Willaume Christoffersen, Hvidovre University Hospital
- Investigators
- Thue Bisgaard, DMSc, Study director, University Hospital of Copenhagen Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635868
- Sponsor's protocol ID
- ABSNOME
- Acronym
- ABSNOME
- Status last verified
- Feb 2014
- First submitted
- 4 Jul 2012
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.
- ClinicalTrials.gov ID
- NCT01635868
- Acronym / sponsor ID
- ABSNOME / ABSNOME
- Conditions
- Ventral Hernia Midline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,313 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Jul 2012 (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.
Background Mesh repair reduces the risk of reoperation for recurrence in patients with small umbilical and epigastric hernias compared with sutured repair. However, reoperation for recurrence underestimates total recurrence (reoperation or clinical) and mesh reinforcement may induce chronic pain. This study investigated the cumulated risk of recurrence after open mesh and sutured repair in small (≤2 cm) umbilical and epigastric hernias. Possible risk factors were evaluated for chronic pain and recurrence.
Methods A cohort study with questionnaire-follow-up was conducted. Patients with primary, elective, open mesh or sutured repair for a small umbilical or epigastric hernia (≤2 cm) were included. Follow-up was performed by a validated questionnaire regarding suspicion of recurrence and chronic pain (moderate or severe). Suspected recurrence qualified for clinical examination. Recurrence was defined as reoperation for recurrence or clinical recurrence. Risk factors for recurrence and chronic pain were investigated by multivariate analyses.
Results
1 313 patients completed the questionnaire and/or clinical follow-up (83 % response rate) and follow-up time was median 40 months (range 0-66 months). The total cumulated recurrence rate 55 months after primary repair was 10 % for mesh repair and 21 % for sutured repair (P=0.001). The incidence of chronic pain was 6 % after mesh repair and 5 % after sutured repair (P = 0.711). Recurrence was the only independent risk factor for chronic pain (P<0.001).
Conclusion Mesh repair halved the long-term risk of recurrence after repair for small umbilical and epigastric hernias without increased risk of chronic pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| umbilical hernia repair | – | –patients having umbilical or epigastric hernia repair from 2008-2010 in Zealand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patient having mesh or sutured repair of small (> 2 cm) umbilical or epigastric hernias in the region of Zealand from 1th of January 2008 to 31th of December 2010.
Key inclusion criteria (1 listed)
- elective open mesh or sutured repair of small umbilical or epigastric hernia repairs
Key exclusion criteria (3 listed)
- acute operation
- operation outside region of Zealand
- laparoscopic repair
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
recurrence (clinical or reoperation for recurrence)
Time frame: 3 years
follow-up time will be from 3-5 years
1 secondary outcome
chronic pain
Time frame: 3-5 years after 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 20 Feb 2014.
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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.
Thue Bisgaard, DMSc study director
University Hospital of Copenhagen Hvidovre
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 Ventral Hernia Midline, run by Hvidovre University Hospital at 1 site in Denmark.
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 3 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 20 Feb 2014. 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 Denmark. 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?
recurrence (clinical or reoperation for recurrence) (time frame: 3 years). 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 20 Feb 2014.