Inguinal HerniaNCT01105039
Detailed Pain Pattern After Laparoscopic Inguinal Hernia Repair
An observational study of Inguinal Hernia and Femoral Hernia, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Pain after laparoscopic groin hernia repair consist of different pain components (overall pain, shoulder pain, incisional pain and visceral pain). Thus it is important to find out which of these pain components that is most severe, so intervention can be targeted. Read more about this study
- Who is it for?
- Ages 18 to 69 years, men only
- Conditions the study is for
- Inguinal Hernia, Femoral Hernia
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to Sep 2010
- 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 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients are consecutively included in this study. They are all undergoing elective laparoscopic groin hernia repair.
Who may be able to join
- men
- 18-69 years
- uni- or bilateral hernia
- ASA I-II
- Danish speaking
Who cannot join
- bad compliance
- acute operation
- daily intake of opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Pain Pattern and Its Components After Laparoscopic Inguinal Hernia Repair
Pain after laparoscopic groin hernia repair consist of different pain components (overall pain, shoulder pain, incisional pain and visceral pain). Thus it is important to find out which of these pain components that is most severe, so intervention can be targeted.
Read the detailed description
Details about the components of early pain after laparoscopic groin hernia repair are lacking. A description of each component (overall pain, shoulder pain,incisional pain and visceral pain) is needed, so intervention against the different pain components can be targeted.
Patients fill out questionnaires about pain before operation and day 0-3 after operation.
- Conditions
- Inguinal Hernia, Femoral Hernia
- Keywords
- Pain pattern, overall pain, incisional pain, shoulder pain, visceral pain
- Medical subject headings
- Hernia, Inguinal, Hernia, Femoral, Shoulder Pain, Visceral Pain
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 |
|---|---|---|
| lap. hernia repair | undergoing laparoscopic groin hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall pain during coughing (visual analog scale)
Measured: 3 days
Secondary outcomes (3)
shoulder pain during coughing (visual analog scale and verbal rating scale)
Measured: 3 days
incisional pain during coughing (visual analog scale and verbal rating scale)
Measured: 3 days
visceral pain during coughing (visual analog scale and verbal rating scale)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionSep 2010
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.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mette A Tolver, M.D., Principal investigator, Koge Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105039
- Sponsor's protocol ID
- SJ-125X
- Status last verified
- Feb 2011
- First submitted
- 13 Apr 2010
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Pain Pattern and Its Components After Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT01105039
- Acronym / sponsor ID
- SJ-125X
- Conditions
- Inguinal Hernia, Femoral Hernia
- Keywords
- Pain pattern, overall pain, incisional pain, shoulder pain, visceral pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Apr 2010 (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.
Pain after laparoscopic groin hernia repair consist of different pain components (overall pain, shoulder pain, incisional pain and visceral pain). Thus it is important to find out which of these pain components that is most severe, so intervention can be targeted.
Detailed description
Details about the components of early pain after laparoscopic groin hernia repair are lacking. A description of each component (overall pain, shoulder pain,incisional pain and visceral pain) is needed, so intervention against the different pain components can be targeted.
Patients fill out questionnaires about pain before operation and day 0-3 after operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lap. hernia repair | – | –undergoing laparoscopic groin hernia repair |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are consecutively included in this study. They are all undergoing elective laparoscopic groin hernia repair.
Key inclusion criteria (5 listed)
- men
- 18-69 years
- uni- or bilateral hernia
- ASA I-II
- Danish speaking
Key exclusion criteria (3 listed)
- bad compliance
- acute operation
- daily intake of opioids
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
Overall pain during coughing (visual analog scale)
Time frame: 3 days
3 secondary outcomes
shoulder pain during coughing (visual analog scale and verbal rating scale)
Time frame: 3 days
incisional pain during coughing (visual analog scale and verbal rating scale)
Time frame: 3 days
visceral pain during coughing (visual analog scale and verbal rating scale)
Time frame: 3 days
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 18 Apr 2011.
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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.
Mette A Tolver, M.D. principal investigator
Koge Hospital
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 Femoral Hernia, run by Zealand 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 5 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 18 Apr 2011. 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?
Overall pain during coughing (visual analog scale) (time frame: 3 days). 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 18 Apr 2011.