Ventral HerniaNCT00573105
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
A study testing Laparoscopic Ventral hernia repair by heavy weight mesh and Laparoscopic Ventral hernia repair by lighter weight mesh in people with Ventral Hernia, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
1. General antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery 2. Laparoscopic surgery at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm) with or without anchoring transparietal sutures or double crown technique 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?
- Laparoscopic Ventral hernia repair by heavy weight mesh and Laparoscopic Ventral hernia repair by lighter weight mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2008to Nov 2010
- 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 patient or his/her legal representative
- ventral hernia requiring elective surgical repair
Who cannot join
- no written informed consent
- 'hostile' abdomen; open abdomen treatment
- contraindication to pneumoperitoneum
- emergency surgery (incarcerated hernia)
- parastomal hernia
Trial locations and contacts
1 site in 1 country.
About this study
- General
- antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery
- Laparoscopic surgery
- at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
- with or without anchoring transparietal sutures or double crown technique
- Conditions
- Ventral Hernia
- Being tested
- Laparoscopic Ventral hernia repair by heavy weight mesh, Laparoscopic Ventral hernia repair by lighter weight mesh
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Ventral hernia repair by heavy weight meshProcedure or surgery
Laparoscopic Ventral hernia repair by heavy weight mesh
Laparoscopic Ventral hernia repair by lighter weight meshProcedure or surgery
Laparoscopic Ventral hernia repair by lighter weight mesh
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Laparoscopic Ventral hernia repair by heavy weight mesh Receives: Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh |
| 2 | Experimental | Laparoscopic Ventral hernia repair by lighter weight mesh Receives: Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
Measured: after 1 year
Secondary outcomes (4)
morbidity rate
Measured: perioperative
quality of life
Measured: after 1 year
postoperative pain
Measured: within 1 week
long term complication rate
Measured: after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: slow inclusion rate
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- C. R. Bard
- Investigators
- Frederik Berrevoet, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573105
- Sponsor's protocol ID
- 2007/421
- Status last verified
- Jan 2011
- First submitted
- 11 Dec 2007
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
- ClinicalTrials.gov ID
- NCT00573105
- Acronym / sponsor ID
- 2007/421
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow inclusion rate
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- C. R. Bard
- Study start
- Feb 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Dec 2007 (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.
- General
- antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery
- Laparoscopic surgery
- at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
- with or without anchoring transparietal sutures or double crown technique
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Laparoscopic Ventral hernia repair by heavy weight meshLaparoscopic Ventral hernia repair by heavy weight mesh |
| 2 | Experimental | Procedure: Laparoscopic Ventral hernia repair by lighter weight meshLaparoscopic Ventral hernia repair by lighter weight mesh |
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 patient or his/her legal representative
- ventral hernia requiring elective surgical repair
Key exclusion criteria (5 listed)
- no written informed consent
- 'hostile' abdomen; open abdomen treatment
- contraindication to pneumoperitoneum
- emergency surgery (incarcerated hernia)
- parastomal 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 |
|---|---|---|
| Laparoscopic Ventral hernia repair by heavy weight meshLaparoscopic Ventral hernia repair by heavy weight mesh | Procedure or surgery | 1 |
| Laparoscopic Ventral hernia repair by lighter weight meshLaparoscopic Ventral hernia repair by lighter weight mesh | Procedure or surgery | 2 |
Primary outcome
recurrence rate
Time frame: after 1 year
4 secondary outcomes
morbidity rate
Time frame: perioperative
quality of life
Time frame: after 1 year
postoperative pain
Time frame: within 1 week
long term complication rate
Time frame: after 1 year
Results and safety
The study was stopped early (reason given: slow inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Ventral hernia repair by heavy weight mesh and Laparoscopic Ventral hernia repair by lighter weight mesh in people with Ventral Hernia, run by University Hospital, Ghent 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 2 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: stopped early, as of the sponsor's last update on 26 Jan 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 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 was stopped early (reason given: slow inclusion rate). Results are not available in the source record.
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?
recurrence rate (time frame: after 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 26 Jan 2011.