Inguinal Hernialife-inNCT01289093
Quality of Life After Laparoscopic Inguinal- Incisional and Umbilical Herniotomy.
An observational study of Inguinal Hernia and Incisional Hernia, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a disease-specific quality of life questionnaire, designed by an American group, to monitor quality of life in patients undergoing operation for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia, Incisional Hernia, Umbilical Hernias
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to May 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care
Who may be able to join
- elective laparoscopic and open operations for inguinal hernia
- elective laparoscopic operation for incisional- and umbilical hernia
- primary hernia
- uni-bilateral hernias and one or more incisional hernias
Who cannot join
- expected bad compliance to the study
- acute operations
- re-operations
- secondary operations
- primary operation with reoperation within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life After Laparoscopic Inguinal- Incisional- and Umbilical Herniotomy.
LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a disease-specific quality of life questionnaire, designed by an American group, to monitor quality of life in patients undergoing operation for hernias.
The investigators wish to test this questionnaire against Visual Analogue Scale (VAS) scores for core-hernia symptoms, to see if the CCS is a good way to monitor the changes in quality of life and other well-known core-symptoms before and after herniotomies.
Read the detailed description
The investigators include consecutively all in all 140 patients. 100 with inguinal hernias; 50 who is getting a Lichtenstein operation and 50 who is getting a laparoscopic operation. Furthermore minimum 20 patients who is getting a laparoscopic operation for incisional hernia and minimum 20 who went through umbilical herniotomy. The investigators monitor their pain, sensation of mesh, movement limitations, over-all well-being, fatigue and life-quality, with both CCS and VAS questionnaires 5 times. One time preoperative and 4 times after operation, on the 1sth, 7th, 30th and 90th day after operation.
- Conditions
- Inguinal Hernia, Incisional Hernia, Umbilical Hernias
- Keywords
- inguinal hernia, incisional hernia, quality of life, disease-specific
- Medical subject headings
- Hernia, Inguinal, Incisional Hernia, Hernia, Umbilical
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 |
|---|---|---|
| laparoscopic ingunal herniotomy | Not described | |
| laparoscopic incisional herniotomy | Not described | |
| Lichtenstein inguinal herniotomy | Not described | |
| laparoscopic umbilical hernia repair | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
pain, sensation of mesh, movement limitations, over-all well-being, fatigue and quality of life. These core symptoms will be measured 5 times with the 2 questionnaires CCS and VAS. One time before and 4 times after the operation with both the CCS and VAS, to see if the is a graphical correlation between the to questionnaires and to find out which of the two questionnaires is best.
Measured: before operation until 90 days postoperative
Secondary outcomes (1)
acceptability
The investigators measure the patients satisfaction with the instruments and which one (VAS or CCS) they prefer.
Measured: preoperative untill 90 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionMay 2012
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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen
- Responsible party
- Principal investigator, Mette M W Christoffersen, Zealand University Hospital
- Investigators
- Thue Bisgaard, MD, Study director, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289093
- Sponsor's protocol ID
- 1234
- Acronym
- life-in
- Status last verified
- Jan 2017
- First submitted
- 2 Feb 2011
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Laparoscopic Inguinal- Incisional- and Umbilical Herniotomy.
- ClinicalTrials.gov ID
- NCT01289093
- Acronym / sponsor ID
- life-in / 1234
- Conditions
- Inguinal Hernia, Incisional Hernia, Umbilical Hernias
- Keywords
- inguinal hernia, incisional hernia, quality of life, disease-specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Feb 2011 (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.
LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a disease-specific quality of life questionnaire, designed by an American group, to monitor quality of life in patients undergoing operation for hernias.
The investigators wish to test this questionnaire against Visual Analogue Scale (VAS) scores for core-hernia symptoms, to see if the CCS is a good way to monitor the changes in quality of life and other well-known core-symptoms before and after herniotomies.
Detailed description
The investigators include consecutively all in all 140 patients. 100 with inguinal hernias; 50 who is getting a Lichtenstein operation and 50 who is getting a laparoscopic operation. Furthermore minimum 20 patients who is getting a laparoscopic operation for incisional hernia and minimum 20 who went through umbilical herniotomy. The investigators monitor their pain, sensation of mesh, movement limitations, over-all well-being, fatigue and life-quality, with both CCS and VAS questionnaires 5 times. One time preoperative and 4 times after operation, on the 1sth, 7th, 30th and 90th day after operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| laparoscopic ingunal herniotomy | – | – |
| laparoscopic incisional herniotomy | – | – |
| Lichtenstein inguinal herniotomy | – | – |
| laparoscopic umbilical hernia repair | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care
Key inclusion criteria (4 listed)
- elective laparoscopic and open operations for inguinal hernia
- elective laparoscopic operation for incisional- and umbilical hernia
- primary hernia
- uni-bilateral hernias and one or more incisional hernias
Key exclusion criteria (5 listed)
- expected bad compliance to the study
- acute operations
- re-operations
- secondary operations
- primary operation with reoperation within 30 days
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
quality of life
Time frame: before operation until 90 days postoperative
pain, sensation of mesh, movement limitations, over-all well-being, fatigue and quality of life. These core symptoms will be measured 5 times with the 2 questionnaires CCS and VAS. One time before and 4 times after the operation with both the CCS and VAS, to see if the is a graphical correlation between the to questionnaires and to find out which of the two questionnaires is best.
1 secondary outcome
acceptability
Time frame: preoperative untill 90 days postoperative
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 31 Jan 2017.
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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, MD study director
Zealand University 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 Incisional 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 4 inclusion and 5 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 31 Jan 2017. 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?
quality of life (time frame: before operation until 90 days postoperative). 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 31 Jan 2017.