Ventral HerniaFSNCT01534780
3 Fixation Devices in Laparoscopic Ventral Herniotomy
A study testing laparoscopic ventral herniotomy, Protack and Securestrap in people with Ventral Hernia, run by Horsens Hospital at 1 site in Denmark.
Trial summary
Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh. Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- laparoscopic ventral herniotomy, Protack and Securestrap
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Aug 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ventral hernia 2(1,5) < dia > 7 cm
- danish speaking
- of sound mind
- bmi < 35
- ASA 3 or less, no contra indication against laparoscopy
Who cannot join
- other size hernias,
- no danish,
- bmi > 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy
Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh.
Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.
Read the detailed description
see brief summary
- Conditions
- Ventral Hernia
- Being tested
- laparoscopic ventral herniotomy, Protack, Securestrap, Glubran
- 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 herniotomyProcedure or surgery
Also called no other names
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices
ProtackDevice
fixation of mesh with protack
SecurestrapDevice
fixation of mesh with Securestrap
GlubranDevice
fixation of mesh with Glubran
| Study group | Role | What they receive |
|---|---|---|
| fixation with Protack | Experimental | Not described Receives: Procedure: laparoscopic ventral herniotomy; Device: Protack |
| fixation with Securestrap | Experimental | Not described Receives: Procedure: laparoscopic ventral herniotomy; Device: Securestrap |
| fixation with Glubran | Experimental | surgery Receives: Procedure: laparoscopic ventral herniotomy; Device: Glubran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Dolo Test (VAS)
Measured: 1 measurement, 2nd postoperative day
Secondary outcomes (3)
hernia recurrence
clinical examination and perhaps CT scan
Measured: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
quality of life
SF 36 and Carolina's Comfort Scale
Measured: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
Pain
Dolo Test(VAS)
Measured: 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startApr 2013
- Primary completionAug 2017
- Study completionAug 2017
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 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horsens Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital
- Responsible party
- Principal investigator, Hans Friis-Andersen, Horsens Hospital
- Investigators
- Sanne S Harsløf, MD, Study chair, Regionshospitalet HorsensThorbjørn Sommer, MD, PhD, Study director, Randers Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534780
- Sponsor's protocol ID
- KIR-001-HRH
- Acronym
- FS
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2012
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harslof S, Krum-Moller P, Sommer T, Zinther N, Wara P, Friis-Andersen H. Effect of fixation devices on postoperative pain after laparoscopic ventral hernia repair: a randomized clinical trial of permanent tacks, absorbable tacks, and synthetic glue. Langenbecks Arch Surg. 2018 Jun;403(4):529-537. doi: 10.1007/s00423-018-1676-z. Epub 2018 May 25.
PubMed 29799075
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy
- ClinicalTrials.gov ID
- NCT01534780
- Acronym / sponsor ID
- FS / KIR-001-HRH
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Horsens HospitalUniversity, hospital or other
- Collaborators
- Randers Regional Hospital
- Study start
- Apr 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Feb 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.
Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh.
Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.
Detailed description
see brief summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fixation with Protack | Experimental | Procedure: laparoscopic ventral herniotomy, Device: Protack |
| fixation with Securestrap | Experimental | Procedure: laparoscopic ventral herniotomy, Device: Securestrap |
| fixation with Glubran | Experimental | Procedure: laparoscopic ventral herniotomy, Device: Glubransurgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ventral hernia 2(1,5) < dia > 7 cm
- danish speaking
- of sound mind
- bmi < 35
- ASA 3 or less, no contra indication against laparoscopy
Key exclusion criteria (3 listed)
- other size hernias,
- no danish,
- bmi > 35
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 herniotomyAlso: no other namesLaparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices | Procedure or surgery | fixation with Glubran, fixation with Protack, fixation with Securestrap |
| Protackfixation of mesh with protack | Device | fixation with Protack |
| Securestrapfixation of mesh with Securestrap | Device | fixation with Securestrap |
| Glubranfixation of mesh with Glubran | Device | fixation with Glubran |
Primary outcome
Pain
Time frame: 1 measurement, 2nd postoperative day
Dolo Test (VAS)
3 secondary outcomes
hernia recurrence
Time frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
quality of life
Time frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
Pain
Time frame: 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24
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 19 Feb 2020.
- Derived from this study: PubMed 29799075Harslof S, Krum-Moller P, Sommer T, Zinther N, Wara P, Friis-Andersen H. Effect of fixation devices on postoperative pain after laparoscopic ventral hernia repair: a randomized clinical trial of permanent tacks, absorbable tacks, and synthetic glue. Langenbecks Arch Surg. 2018 Jun;403(4):529-537. doi: 10.1007/s00423-018-1676-z. Epub 2018 May 25.
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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.
Sanne S Harsløf, MD study chair
Regionshospitalet Horsens
Thorbjørn Sommer, MD, PhD study director
Randers Regional Hospital
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 herniotomy, Protack and Securestrap in people with Ventral Hernia, run by Horsens Hospital at 1 site in Denmark.
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 5 inclusion and 3 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 19 Feb 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 Denmark. 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?
Pain (time frame: 1 measurement, 2nd postoperative day). 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 NCT01534780, 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 19 Feb 2020.