- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01534780
3 Fixation Devices in Laparoscopic Ventral Herniotomy (FS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Horsens, Denmark, 8700
- Regional Hospital Horsens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ventral hernia 2(1,5) < dia > 7 cm
- danish speaking
- of sound mind
- bmi < 35
- ASA 3 or less, no contra indication against laparoscopy
Exclusion Criteria:
- other size hernias,
- no danish,
- bmi > 35
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fixation with Protack
|
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally.
Fixation of the mesh is performed with 1 of 3 possible devices
Other Names:
fixation of mesh with protack
|
Experimental: fixation with Securestrap
|
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally.
Fixation of the mesh is performed with 1 of 3 possible devices
Other Names:
fixation of mesh with Securestrap
|
Experimental: fixation with Glubran
surgery
|
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally.
Fixation of the mesh is performed with 1 of 3 possible devices
Other Names:
fixation of mesh with Glubran
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 1 measurement, 2nd postoperative day
|
Dolo Test (VAS)
|
1 measurement, 2nd postoperative day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hernia recurrence
Time Frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
|
clinical examination and perhaps CT scan
|
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
|
SF 36 and Carolina's Comfort Scale
|
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
|
Dolo Test(VAS)
|
7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Sanne S Harsløf, MD, Horsens Regional Hospital
- Study Director: Thorbjørn Sommer, MD, PhD, Randers Regional Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KIR-001-HRH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventral Hernia
-
Varazdin General HospitalCompletedIncisional Ventral Hernia | Recurrent Ventral HerniaCroatia
-
Anne Arundel Health System Research InstituteMedtronic - MITGCompletedGrade I Ventral Hernia | Grade II Ventral HerniaUnited States
-
University Hospital, Strasbourg, FranceRecruitingVentral Hernia RepairFrance
-
Makassed General HospitalSuspended
-
Sofregen Medical, Inc.TerminatedVentral Hernia RepairUnited States
-
Zaza DemetrashviliRecruitingLarge Midline Ventral HerniaGeorgia
-
Hvidovre University HospitalUniversity of CopenhagenCompleted
-
Hvidovre University HospitalCopenhagen University Hospital at HerlevCompleted
-
Hospices Civils de LyonRecruiting
-
Medtronic - MITGCompletedVentral Incisional HerniaFrance
Clinical Trials on laparoscopic ventral herniotomy
-
The Cleveland ClinicTerminatedRectal Prolapse | ProcidentiaUnited States
-
Alexander KhitaryanRecruitingRectal Prolapse | Rectocele; Female | Rectocele and Incomplete Uterine Prolapse | Rectocele and Complete Uterovaginal ProlapseRussian Federation
-
University of Rome Tor VergataUnknown
-
Fundación Andaluza Beturia para la Investigación...Completed
-
University Hospital, GhentC. R. BardTerminatedVentral HerniaBelgium
-
King Edward Medical UniversityCompletedHernia, InguinalPakistan
-
Mansoura UniversityCompletedRectocele | Obstructive Defecation SyndromeEgypt
-
Oslo University HospitalTyco Healthcare GroupCompleted
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity of BolognaUnknownRectocele | Rectal Prolapse | Sensation of Inadequate DefecationItaly
-
Oslo University HospitalSykehuset Innlandet HFCompleted