Inguinal HerniaNCT01669837
An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias
An observational study of Inguinal Hernia, run by Duomed at 1 site in Belgium.
Trial summary
Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Mesh fixation with surgical tissue glue
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- May 2012to Mar 2020
- 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 with a primary inguinal hernia
Who may be able to join
- Patient is older than 18 years.
- Written informed consent is obtained from patient.
- Patient is able to complete the EQ-5D questionnaire.
- Patient has a primary unilateral or primary bilateral inguinal hernia- Mesh fixation is established with solely surgical tissue glue (Ifbond™).
Who cannot join
- Patient has a recurrent inguinal hernia.
- Patient is treated using the Lichtenstein technique.
- Mesh fixation with sutures, tacks, absorbable tacks or clips.
- Patient is allergic to components of surgical tissue glue (Ifbond™).
- Patient has a life expectancy of less than 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry
Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year.
- Conditions
- Inguinal Hernia
- Being tested
- Mesh fixation with surgical tissue glue
- Keywords
- Inguinal hernia, Laparoscopy, Surgical tissue glue
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh fixation with surgical tissue glueDevice
Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Administration of surgical tissue glue. Receives: Device: Mesh fixation with surgical tissue glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.
Measured: up to 1 year
Secondary outcomes (6)
Intraoperative complications
Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.
Measured: 1 day
Postoperative complications
Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.
Measured: Up to 30 days after index-procedure
Analgesic intake
Intake of analgesics.
Measured: Discharge, 5 weeks
Quality of life (QOL)
QOL assessed by EQ-5D questionnaire.
Measured: Preoperative, 5 weeks, 1 year
Freedom from hernia-related reinterventions
Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.
Measured: 1 year
Late complications
Local numbness, groin discomfort, hernia recurrence, sexual dysfunction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2020
- Study completionMar 2020
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.
- 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kurt Van der Speeten, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669837
- Sponsor's protocol ID
- BM-IFA-06
- Status last verified
- Jun 2020
- First submitted
- 17 Aug 2012
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry
- ClinicalTrials.gov ID
- NCT01669837
- Acronym / sponsor ID
- BM-IFA-06
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal hernia, Laparoscopy, Surgical tissue glue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- DuomedIndustry (pharma, biotech, devices)
- Study start
- May 2012 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 21 Aug 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.
Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Device: Mesh fixation with surgical tissue glueAdministration of surgical tissue glue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a primary inguinal hernia
Key inclusion criteria (4 listed)
- Patient is older than 18 years.
- Written informed consent is obtained from patient.
- Patient is able to complete the EQ-5D questionnaire.
- Patient has a primary unilateral or primary bilateral inguinal hernia- Mesh fixation is established with solely surgical tissue glue (Ifbond™).
Key exclusion criteria (5 listed)
- Patient has a recurrent inguinal hernia.
- Patient is treated using the Lichtenstein technique.
- Mesh fixation with sutures, tacks, absorbable tacks or clips.
- Patient is allergic to components of surgical tissue glue (Ifbond™).
- Patient has a life expectancy of less than 1 year.
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 |
|---|---|---|
| Mesh fixation with surgical tissue glueLaparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation | Device | Patient group |
Primary outcome
Postoperative pain
Time frame: up to 1 year
Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.
6 secondary outcomes
Intraoperative complications
Time frame: 1 day
Postoperative complications
Time frame: Up to 30 days after index-procedure
Analgesic intake
Time frame: Discharge, 5 weeks
Quality of life (QOL)
Time frame: Preoperative, 5 weeks, 1 year
Freedom from hernia-related reinterventions
Time frame: 1 year
Late complications
Time frame: 1 year
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 Jun 2020.
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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.
Kurt Van der Speeten, MD principal investigator
Ziekenhuis Oost-Limburg
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, run by Duomed at 1 site 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 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 18 Jun 2020. 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 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?
Postoperative pain (time frame: up to 1 year). 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 Jun 2020.