Primary Unilateral Inguinal HerniasLIQUORNCT01936584
Validation of Quality of Life Assessment After Laparoscopic TAPP and TEP Surgery of Inguinal Hernias Using EuraHS of Life Score and Carolinas Comfort Scale™
An observational study of Primary Unilateral Inguinal Hernias, run by University Hospital, Ghent at 3 sites in Belgium.
Trial summary
A multicenter observational study trial validating Quality of Life assessment using EuraHS Quality of Life score and Carolinas Comfort scale™ in patients before and after laparoscopic unilateral inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Unilateral Inguinal Hernias
- What is being tested?
- TAPP repair for inguinal hernias, TEP repair for inguinal hernia and EuraHS-QoL questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 101 participants
- Where
- 3 sitesBelgium
- Study dates
- Sep 2013to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing laparoscopic unilateral inguinal hernia repair
Who may be able to join
- Written informed consent from the patient or his/her legal representative
- Primary unilateral inguinal hernia undergoing a preperitoneal laparoscopic repair.
Who cannot join
- No written informed consent
- Recurrent groin hernia
- Open hernia repair
- Bilateral hernias
- Concomitant repair of another abdominal hernia eg umbilical hernia
- Hernia repair combined with another surgical procedure
Show all 11Show fewer
- Emergency operations, like incarcerated hernias
- Patients under the age of 18 years and over 80 years
- Pregnant women
- ASA score 4 or more
- Patients unable to perform the QoL assessment, because of language barrier or intellectual incapacity
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
AZ Maria Middelares
Ghent, 9000
University Hospital Ghent
Ghent, 9000
Heilig Hart Ziekenhuis
Mol
About this study
A multicenter observational study trial validating Quality of Life assessment using EuraHS Quality of Life score and Carolinas Comfort scale™ in patients before and after laparoscopic unilateral inguinal hernia repair.
Depending on the treating physician patients will receive a TAPP or TEP repair for their inguinal hernia and a self-gripping mesh will be used for the repair (Parietex Progrip Mesh).
Read more
Primary endpoint will be assessment by the EuraHS-QoL at 1 year after laparoscopic repair of an unilateral inguinal hernia using the Anatomic ProGrip™ Laparoscopic self-fixating mesh.
Secondary endpoints are assessment of the QoL 3 preoperative, 3 weeks and 1 year postoperative, recurrence rate at 12 months, intra-operative and post-operative complications, post-operative hospital stay, operation time and time to place the mesh, VAS (Visual Analog Scale) for pain at several control points, VRS (Verbal Rating Score) for pain at 3 weeks and 12 months, pain medication needed.
- Conditions
- Primary Unilateral Inguinal Hernias
- Being tested
- TAPP repair for inguinal hernias, TEP repair for inguinal hernia, EuraHS-QoL questionnaire, Carolina Comfort Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPP repair for inguinal herniasProcedure or surgery
TEP repair for inguinal herniaProcedure or surgery
EuraHS-QoL questionnaireOther
questionnaire administration
Carolina Comfort ScaleOther
questionnaire administration
| Study group | Role | What they receive |
|---|---|---|
| TAPP repair | TAPP repair for inguinal hernia Receives: Procedure: TAPP repair for inguinal hernias; Other: EuraHS-QoL questionnaire; Other: Carolina Comfort Scale | |
| TEP repair | TEP repair for inguinal hernia Receives: Procedure: TEP repair for inguinal hernia; Other: EuraHS-QoL questionnaire; Other: Carolina Comfort Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the EuraHS-QoL
questionnaire assessment
Measured: 1 year after start study
Secondary outcomes (1)
change in EuraHS-QoL assessment
clinical evaluation, Carolina Comfort Scale™ questionnaire, EuraHS-QoL questionnaire, Visual Analogue Scale and Verbal Rating Score.
Measured: preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Unilateral Inguinal HerniasStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936584
- Sponsor's protocol ID
- EC/2013/381
- Acronym
- LIQUOR
- Status last verified
- Sep 2015
- First submitted
- 2 Sep 2013
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016 Nov;160(5):1344-1357. doi: 10.1016/j.surg.2016.04.026. Epub 2016 Jun 14.
PubMed 27316825
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Quality of Life Assessment After Laparoscopic TAPP and TEP Surgery of Inguinal Hernias Using EuraHS of Life Score and Carolinas Comfort Scale™
- ClinicalTrials.gov ID
- NCT01936584
- Acronym / sponsor ID
- LIQUOR / EC/2013/381
- Conditions
- Primary Unilateral Inguinal Hernias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Sep 2013 (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.
A multicenter observational study trial validating Quality of Life assessment using EuraHS Quality of Life score and Carolinas Comfort scale™ in patients before and after laparoscopic unilateral inguinal hernia repair.
Depending on the treating physician patients will receive a TAPP or TEP repair for their inguinal hernia and a self-gripping mesh will be used for the repair (Parietex Progrip Mesh).
Primary endpoint will be assessment by the EuraHS-QoL at 1 year after laparoscopic repair of an unilateral inguinal hernia using the Anatomic ProGrip™ Laparoscopic self-fixating mesh.
Secondary endpoints are assessment of the QoL 3 preoperative, 3 weeks and 1 year postoperative, recurrence rate at 12 months, intra-operative and post-operative complications, post-operative hospital stay, operation time and time to place the mesh, VAS (Visual Analog Scale) for pain at several control points, VRS (Verbal Rating Score) for pain at 3 weeks and 12 months, pain medication needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAPP repair | – | Procedure: TAPP repair for inguinal hernias, Other: EuraHS-QoL questionnaire, Other: Carolina Comfort ScaleTAPP repair for inguinal hernia |
| TEP repair | – | Procedure: TEP repair for inguinal hernia, Other: EuraHS-QoL questionnaire, Other: Carolina Comfort ScaleTEP repair for inguinal hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing laparoscopic unilateral inguinal hernia repair
Key inclusion criteria (2 listed)
- Written informed consent from the patient or his/her legal representative
- Primary unilateral inguinal hernia undergoing a preperitoneal laparoscopic repair.
Key exclusion criteria (11 listed)
- No written informed consent
- Recurrent groin hernia
- Open hernia repair
- Bilateral hernias
- Concomitant repair of another abdominal hernia eg umbilical hernia
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 |
|---|---|---|
| TAPP repair for inguinal hernias | Procedure or surgery | TAPP repair |
| TEP repair for inguinal hernia | Procedure or surgery | TEP repair |
| EuraHS-QoL questionnairequestionnaire administration | Other | TAPP repair, TEP repair |
| Carolina Comfort Scalequestionnaire administration | Other | TAPP repair, TEP repair |
Primary outcome
assessment of the EuraHS-QoL
Time frame: 1 year after start study
questionnaire assessment
1 secondary outcome
change in EuraHS-QoL assessment
Time frame: preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months
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 Sep 2015.
- Derived from this study: PubMed 27316825Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016 Nov;160(5):1344-1357. doi: 10.1016/j.surg.2016.04.026. Epub 2016 Jun 14.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Unilateral Inguinal Hernias, run by University Hospital, Ghent at 3 sites in Belgium.
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 2 inclusion and 11 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 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
assessment of the EuraHS-QoL (time frame: 1 year after start study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01936584, which also lists 1 linked publication.
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 Sep 2015.