Chronic PainNCT01741740
Chronic Complaints After Small Umbilical Hernia Repair
An observational study of Chronic Pain and Ventral Hernia, run by Hvidovre University Hospital.
Trial summary
There are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Ventral Hernia
- How many people
- 295 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Jan 2009
- 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: Consecutive patients undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repair during a five years period
Who may be able to join
- primary elective open non-mesh sutured umbilical or epigastric hernia repair
Who cannot join
- mesh repair, acute repair, repair secondary to other operation, recurrent hernia repair, combined hernia repair, laparoscopic hernie repair, trocar hernia repair, incompensated liver cirrhosis, age < 18 years, pregnancy
About this study
Official title: High Incidence of Chronic Complaints and Recurrence 5 Years After Simple Sutured Umbilical Hernia Repair
There are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. The setup was a retrospective two-centre study including patients ≥18 years undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The survey included questions on suspicion of recurrence, reoperation for recurrence (if yes patients were examined by a consultant in patients home), pain, discomfort, work, and leisure activities. We analysed 295 consecutive patients through a non-validated structured questionnaire.
- Conditions
- Chronic Pain, Ventral Hernia
- Keywords
- pain, hernia, chronic, discomfort, retrospective
- Medical subject headings
- Chronic Pain, Hernia, Ventral, Pain, Hernia, Bronchiolitis Obliterans Syndrome
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 |
|---|---|---|
| retrospective surgical patients | consecutive elective umbilical hernia repair patients during two years from two hospitals,- retrospective id with prospective follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain at rest at the hernia repair site
a verbal rating scale for pain is used (none, little, moderate or severe
Measured: chronic complaints 5 years after hernia repair
Secondary outcomes (1)
discomfort at rest at the hernia site
a verbal rating scale for pain is used (none, little, moderate or severea
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJan 2000
- Primary completionJan 2005
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thue Bisgaard, Hvidovre University Hospital
- Investigators
- Thue Bisgaard, DMSc, Principal investigator, Hvidovre and Glostrup University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741740
- Sponsor's protocol ID
- SMALLUMBI123
- Status last verified
- Dec 2012
- First submitted
- 3 Dec 2012
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Incidence of Chronic Complaints and Recurrence 5 Years After Simple Sutured Umbilical Hernia Repair
- ClinicalTrials.gov ID
- NCT01741740
- Acronym / sponsor ID
- SMALLUMBI123
- Conditions
- Chronic Pain, Ventral Hernia
- Keywords
- pain, hernia, chronic, discomfort, retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 Dec 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.
There are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. The setup was a retrospective two-centre study including patients ≥18 years undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The survey included questions on suspicion of recurrence, reoperation for recurrence (if yes patients were examined by a consultant in patients home), pain, discomfort, work, and leisure activities. We analysed 295 consecutive patients through a non-validated structured questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| retrospective surgical patients | – | –consecutive elective umbilical hernia repair patients during two years from two hospitals,- retrospective id with prospective follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repair during a five years period
Key inclusion criteria (1 listed)
- primary elective open non-mesh sutured umbilical or epigastric hernia repair
Key exclusion criteria (1 listed)
- mesh repair, acute repair, repair secondary to other operation, recurrent hernia repair, combined hernia repair, laparoscopic hernie repair, trocar hernia repair, incompensated liver cirrhosis, age < 18 years, pregnancy
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
pain at rest at the hernia repair site
Time frame: chronic complaints 5 years after hernia repair
a verbal rating scale for pain is used (none, little, moderate or severe
1 secondary outcome
discomfort at rest at the hernia site
Time frame: 5 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 24 Dec 2012.
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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 principal investigator
Hvidovre and Glostrup University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Ventral Hernia, run by Hvidovre University 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 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 24 Dec 2012. 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?
pain at rest at the hernia repair site (time frame: chronic complaints 5 years after hernia repair). 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 24 Dec 2012.