Ventral HerniaCLOSURENCT01719718
The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair
A study testing Closure of hernia defect. and No closure of the hernia defect. in people with Ventral Hernia, run by University Hospital, Ghent at 6 sites in Belgium.
Trial summary
A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair. 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?
- Closure of hernia defect. and No closure of the hernia defect.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 6 sitesBelgium
- Study dates
- Oct 2012to 31 Dec 2023
- 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 or incisional hernia requiring elective surgical repair
- Diameter between 2 and 5cm in width
- Midline and flank hernias are eligible
Who cannot join
- No written informed consent
- 'Hostile' abdomen, open abdomen treatment
- Contraindication to pneumoperitoneum
- Emergency surgery (incarcerated hernia)
- Parastomal hernia
- Subxiphoidal hernia
Show all 12Show fewer
- Subcostal hernia
- Suprapubic hernia
- Clean-contaminated or contaminated field
- Hernia diameter >5cm in width
- Pregnancy
- Non-compliance
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
Algemeen Stedelijk Ziekenhuis
Aalst
Imelda Hospital
Bonheiden
St Vincentius Hospital
Deinze
Ghent University Hospital
Ghent, 9000
Maria Middelares
Ghent, 9000
Hôpital Mont Godinne
Namur
About this study
Official title: The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair.
A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.
- Conditions
- Ventral Hernia
- Being tested
- Closure of hernia defect., No closure of the hernia defect.
- 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.
Closure of hernia defect.Procedure or surgery
Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).
No closure of the hernia defect.Procedure or surgery
Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).
| Study group | Role | What they receive |
|---|---|---|
| Closure | Active comparator | Not described Receives: Procedure: Closure of hernia defect. |
| Non-Closure | Sham comparator | Not described Receives: Procedure: No closure of the hernia defect. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma formation after 4 weeks.
The seroma formation is checked by clinical evaluation.
Measured: 4 weeks after surgery.
Secondary outcomes (3)
Pain, discomfort and esthetic evaluation after 4 weeks.
Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.
Measured: 4 weeks after surgery.
Pain, discomfort and esthetic evaluation after 1 year.
Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.
Measured: 1 year after surgery.
Pain, discomfort and esthetic evaluation after 2 years.
Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.
Measured: 2 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completion31 Dec 2023
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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD, PhD, FACS, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719718
- Sponsor's protocol ID
- 2012/075
- Acronym
- CLOSURE
- Status last verified
- May 2024
- First submitted
- 30 Oct 2012
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair.
- ClinicalTrials.gov ID
- NCT01719718
- Acronym / sponsor ID
- CLOSURE / 2012/075
- Conditions
- Ventral Hernia
- Keywords
- ventral hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Nov 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.
A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closure | Active comparator | Procedure: Closure of hernia defect. |
| Non-Closure | Sham comparator | Procedure: No closure of the hernia defect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent from the patient or his/her legal representative
- Ventral or incisional hernia requiring elective surgical repair
- Diameter between 2 and 5cm in width
- Midline and flank hernias are eligible
Key exclusion criteria (12 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 |
|---|---|---|
| Closure of hernia defect.Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique). | Procedure or surgery | Closure |
| No closure of the hernia defect.Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique). | Procedure or surgery | Non-Closure |
Primary outcome
Seroma formation after 4 weeks.
Time frame: 4 weeks after surgery.
The seroma formation is checked by clinical evaluation.
3 secondary outcomes
Pain, discomfort and esthetic evaluation after 4 weeks.
Time frame: 4 weeks after surgery.
Pain, discomfort and esthetic evaluation after 1 year.
Time frame: 1 year after surgery.
Pain, discomfort and esthetic evaluation after 2 years.
Time frame: 2 years after 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 17 May 2024.
- Related InfoLink 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, PhD, FACS principal investigator
University Hospital, Ghent
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of hernia defect. and No closure of the hernia defect. in people with Ventral Hernia, run by University Hospital, Ghent at 6 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 4 inclusion and 12 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 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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?
Seroma formation after 4 weeks. (time frame: 4 weeks 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 17 May 2024.