Ventral HerniaSORBETNCT01109771
Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair
A study testing permanent mesh fixation and absorbable mesh fixation in people with Ventral Hernia, run by University Hospital, Ghent at 11 sites in Belgium.
Trial summary
To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- permanent mesh fixation and absorbable mesh fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 11 sitesBelgium
- Study dates
- Apr 2010to 31 Aug 2015
- Phase
- Interventional
- 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
Who may be able to join
- written informed consent from the adult patient (18 years and older, no maximum age)
- primary, incisional or recurrent midline ventral hernia requiring elective laparoscopic repair
Who cannot join
- no written informed consent
- hernia defects larger than 10cm diameter in width
- 'hostile' abdomen; open abdomen treatment
- contraindication to pneumoperitoneum
- emergency surgery (incarcerated hernia)
- lateral or parastomal hernia sites
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Belgium11 sites
Imelda Ziekenhuis
Bonheiden
CHU Charleroi
Charleroi
St-Vincentius Ziekenhuis
Deinze
AZ Sint-Dymphna
Geel
University Hospital Ghent
Ghent
Virga Jesseziekenhuis
Hasselt, Limburg, 3500
Ziekenhuis Maas en Kempen
Maaseik
AZ Sint-Maarten
Mechelen
Heilig Hart Ziekenhuis
Mol
UCL Mont-Godinne
Namur
H. Serruys Ziekenhuis
Ostend
About this study
Official title: Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET Trial)
To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial.
All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.
- Conditions
- Ventral Hernia
- Being tested
- permanent mesh fixation, absorbable mesh fixation
- Keywords
- Ventral hernia
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
permanent mesh fixationDevice
Permanent mesh fixation will be used.
absorbable mesh fixationDevice
Absorbable mesh fixation will be used.
| Study group | Role | What they receive |
|---|---|---|
| absorbable fixation left side | Active comparator | Not described Receives: Device: permanent mesh fixation; Device: absorbable mesh fixation |
| absorbable fixation right side | Active comparator | Not described Receives: Device: permanent mesh fixation; Device: absorbable mesh fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with a VAS scale more than 40
The Visual Analogue Scale (VAS) is commonly used to measure the intensity of pain or other subjective experiences. It is a simple and effective tool.
The VAS consists of a straight line, usually 10 cm long, with endpoints defining extreme limits such as 'No pain' and 'Worst imaginable pain'. Respondents mark a point on the line that represents their perception of their current state.
Scoring:
Scale Title: Visual Analogue Scale (VAS) Minimum Value: 0 (indicating no pain or the least possible experience of the measured parameter) Maximum Value: 10 (indicating worst imaginable pain or the most extreme experience of the measured parameter) Higher Scores: Indicate a worse outcome (e.g., more intense pain or greater severity of the measured parameter).
Measured: 1 year after surgery
Secondary outcomes (5)
number of invasive interventions (local infiltrations, reoperations) postoperatively
number of invasive interventions (local infiltrations, reoperations) postoperatively, 1 year after surgery
Measured: 1 year after surgery
number of patients taking analgetics using MCGill painscore
The McGill Pain Questionnaire (MPQ) measures the quality and intensity of pain through three components:
Pain Rating Index (PRI): Derived from 78 pain descriptors in four categories: Sensory (S), Affective (A), Evaluative (E), Miscellaneous (M). Each descriptor has a numerical value.
Scale Title: Pain Rating Index (PRI) Range: 0-78 Higher Scores: Indicate greater intensity of pain. Present Pain Intensity (PPI): A single-item scale rating current pain on a 6-point scale.
Scale Title: Present Pain Intensity (PPI) Range: 0 (No Pain) to 5 (Excruciating Pain) Higher Scores: Indicate greater intensity of pain. Number of Words Chosen (NWC): Total pain descriptors selected. Scale Title: Number of Words Chosen (NWC) Range: 0-20 Higher Scores: Indicate more complex or severe pain.
Measured: 1 year post-surgery
perioperative morbidity rate
perioperative morbidity rate, 1 year after surgery
Measured: 1 year after surgery
quality of life by using EQ5D score
The EQ-5D is a standardized instrument for measuring generic health status, providing a descriptive profile and a single index value.
Descriptive System: Comprises five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Each dimension has three severity levels: No problems, Some problems, Extreme problems. Responses form a five-digit number describing the health state (e.g., 11223).
EQ Visual Analogue Scale (EQ VAS): Records self-rated health on a vertical scale from 0 (Worst health) to 100 (Best health), quantifying the patient's overall health perception.
EQ-5D Index Value: Derived from the descriptive system. Scale Title: EQ-5D Index Value Range: Typically -0.594 to 1 Higher Scores: Indicate better health outcomes.
Measured: 1 year post-surgery
recurrence rate
recurrence rate, 1 year post-surgery
Measured: 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2015
- Study completion31 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109771
- Sponsor's protocol ID
- 2008/702
- Acronym
- SORBET
- Status last verified
- Jul 2024
- First submitted
- 22 Apr 2010
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET Trial)
- ClinicalTrials.gov ID
- NCT01109771
- Acronym / sponsor ID
- SORBET / 2008/702
- Conditions
- Ventral Hernia
- Keywords
- Ventral hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Apr 2010 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 23 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.
To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial.
All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| absorbable fixation left side | Active comparator | Device: permanent mesh fixation, Device: absorbable mesh fixation |
| absorbable fixation right side | Active comparator | Device: permanent mesh fixation, Device: absorbable mesh fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- written informed consent from the adult patient (18 years and older, no maximum age)
- primary, incisional or recurrent midline ventral hernia requiring elective laparoscopic repair
Key exclusion criteria (6 listed)
- no written informed consent
- hernia defects larger than 10cm diameter in width
- 'hostile' abdomen; open abdomen treatment
- contraindication to pneumoperitoneum
- emergency surgery (incarcerated 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 |
|---|---|---|
| permanent mesh fixationPermanent mesh fixation will be used. | Device | absorbable fixation left side, absorbable fixation right side |
| absorbable mesh fixationAbsorbable mesh fixation will be used. | Device | absorbable fixation left side, absorbable fixation right side |
Primary outcome
number of patients with a VAS scale more than 40
Time frame: 1 year after surgery
The Visual Analogue Scale (VAS) is commonly used to measure the intensity of pain or other subjective experiences. It is a simple and effective tool. The VAS consists of a straight line, usually 10 cm long, with endpoints defining extreme limits such as 'No pain' and 'Worst imaginable pain'. Respondents mark a point on the line that represents their perception of their current state. Scoring: Scale Title: Visual Analogue Scale (VAS) Minimum Value: 0 (indicating no pain or the least possible experience of the measured parameter) Maximum Value: 10 (indicating worst imaginable pain or the most extreme experience of the measured parameter) Higher Scores: Indicate a worse outcome (e.g., more intense pain or greater severity of the measured parameter).
5 secondary outcomes
number of invasive interventions (local infiltrations, reoperations) postoperatively
Time frame: 1 year after surgery
number of patients taking analgetics using MCGill painscore
Time frame: 1 year post-surgery
perioperative morbidity rate
Time frame: 1 year after surgery
quality of life by using EQ5D score
Time frame: 1 year post-surgery
recurrence rate
Time frame: 1 year post-surgery
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 8 Jul 2024.
- website University Hospital GhentLink provided by the sponsor.
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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.
Frederik Berrevoet, MD principal investigator
University Hospital, Ghent
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing permanent mesh fixation and absorbable mesh fixation in people with Ventral Hernia, run by University Hospital, Ghent at 11 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 6 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
number of patients with a VAS scale more than 40 (time frame: 1 year after surgery). 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 8 Jul 2024.