Back to resultsTacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width
Primary Purpose
Ventral Hernia
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Liquiband Fix8
Absorbable tack
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernia
Eligibility Criteria
Inclusion Criteria:
- Patient with ventral hernia (primary or incisional) with a defect size between 2 and 5 cm and eligible for laparoscopic repair.
- Patients with ASA grade I to III.
- Patient is at least 18 years old.
- Patient must sign and date the informed consent form prior to treatment.
Exclusion Criteria:
- Patient with a recurrence of a previously treated ventral hernia repaired with mesh. Recurrences are only allowed to be included after former primary (suture) repair or retromuscular/onlay mesh repair.
- Patient is treated by open surgery.
- Patient has more than one defect. Treatment of Swiss-cheese defects (multiple small defects) is allowed if all defects can be treated with one mesh. Total width cannot exceed 5 cm.
- Patient with a complex hernia, likely not eligible for laparoscopic repair. Complexity is determined by the investigator (adhesions, small bowel resection, etc).
- Patient with a life expectancy of less than 2 years.
- Patient is suspected of being unable to comply with the study protocol.
- Patient with severe chronic obstructive pulmonary disease.
- Patient with ASA IV or V.
- Patient is pregnant.
- Patient needs acute surgery.
- Patient is scheduled for surgery within 6 weeks after the index-procedure.
- Patient has fibromyalgia.
- Patient with depression as shown in patient medical record.
- Patient is enrolled in another study.
Sites / Locations
- Hospital Network Antwerp (ZNA) Jan Palfijn
- General Hospital Sint Jan Brugge
- University Hospital Brussels
- CHU Charleroi
- General Hospital Sint Vincentius Deinze
- ZOL Genk
- University Hospital Leuven
- CHR Namur
- General Hospital Nikolaas
- Regional Hospital HH Tienen
- General Hospital Delta Torhout
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Liquiband Fix8 glue mesh fixation
Mesh fixation with absorbable tacks
Arm Description
Outcomes
Primary Outcome Measures
Pain in both groups at 4-6 weeks after LVHR using the Visual Analog Scale (VAS)
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
Secondary Outcome Measures
Period of hospitalization
Record the number of days in hospital until discharge
Operating time
Intra-operative adverse events
Intra-operative adverse events include bleeding and enterotomy
Post-operative adverse events
Post-operative adverse events include seroma (i.e. accumulation of wound fluid), ileus (i.e. bowel obstruction), infection, bowel injury, major bleeding requiring blood transfusion or re-intervention, complications due to anesthesia and minor bleeding at a trocar insertion site
Usability of the glue during the index-procedure
Usability scoring: 1 = bad -> 3 = moderate -> 5 = excellent
Technical success of glue fixation
During the index-procedure, the investigator will register whether fixation of the mesh with glue achieved technical success or not. Technical success is defined as successful hernia repair as intended.
Technical success of tack fixation
During the index-procedure, the investigator will register whether fixation of the mesh with tacks achieved technical success or not. Technical success is defined as successful hernia repair as intended.
Pain at baseline using the VAS scale
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
Pain at discharge using the VAS scale
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
Pain at 12 months follow-up using the VAS scale
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
Pain at 24 months follow-up using the VAS scale
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
Postoperative analgesic intake
Period of intake
Postoperative analgesic intake
Type of intake
Period to return to normal activity
Number of days after the index-procedure at which the patient resumes normal activities.
Quality of life at baseline.
The Carolinas Comfort Scale questionnaire is a validated, disease-specific, quality of life questionnaire developed for patients undergoing hernia repair with mesh. It is a 23-item questionnaire that measures severity of pain, sensation, and movement limitations from the mesh in eight categories. The CCS score is derived by adding the scores from each of the 23 items. The best possible score is 0 and the worst possible score is 115.
Quality of life at 4-6 weeks.
CCS questionnaire
Quality of life at 12 months follow-up.
CCS questionnaire
Quality of life at 24 months follow-up.
CCS questionnaire
Recurrences during follow-up
A clinical examination is conducted to evaluate recurrence. If there is any suspicion of recurrence, an ultrasound or MRI is performed according to hospital practice to distinguish true recurrences from bulging.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03429374
Brief Title
Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width
Official Title
Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width: a Multicenter Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Limited patient enrollment
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
May 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duomed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In laparoscopic ventral hernia repair, an abundance of methods has been developed to fix the mesh to the abdominal wall, including sutures (non-absorbable or absorbable), staples (non-absorbable or absorbable), clips, tacks (non-absorbable or absorbable) and (fibrin and synthetic) glues. Which fixation technique is superior, is still under evaluation. There is clearly a need for larger trials to obtain confident results on the safety and performance of glue mesh fixation and tack mesh fixation in LVHR. The hypothesis of this prospective, randomized controlled study is that post-operative pain at 4 to 6 weeks after mesh fixation with glue (LiquiBand® Fix 8™) will not differ compared to treatment with absorbable tacks during LVHR. A total of 510 patients will be recruited for this trial. This study will assess: pain, hernia recurrence, safety, procedural characteristics, technical success, analgesic intake, period to return to normal activity and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomly allocated to group 1 or group 2:
Group 1: Mesh fixation with tacks.
Group 2: Mesh fixation with glue.
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liquiband Fix8 glue mesh fixation
Arm Type
Active Comparator
Arm Title
Mesh fixation with absorbable tacks
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Liquiband Fix8
Intervention Description
LiquiBand® Fix 8™ (Advanced Medical Solutions - Plymouth, UK) is a hernia mesh fixation device providing strong and secure mesh fixation without causing any tissue damage or mechanical trauma. This device is designed to offer precise and controlled delivery of tissue glue (n-butyl-2-cyanoacrylate), resulting in a strong mesh fixation.
Intervention Type
Device
Intervention Name(s)
Absorbable tack
Intervention Description
Absorbable tack
Primary Outcome Measure Information:
Title
Pain in both groups at 4-6 weeks after LVHR using the Visual Analog Scale (VAS)
Description
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
Time Frame
At 4 - 6 weeks
Secondary Outcome Measure Information:
Title
Period of hospitalization
Description
Record the number of days in hospital until discharge
Time Frame
up to 5 days
Title
Operating time
Time Frame
Intra-operatively
Title
Intra-operative adverse events
Description
Intra-operative adverse events include bleeding and enterotomy
Time Frame
Intra-operatively
Title
Post-operative adverse events
Description
Post-operative adverse events include seroma (i.e. accumulation of wound fluid), ileus (i.e. bowel obstruction), infection, bowel injury, major bleeding requiring blood transfusion or re-intervention, complications due to anesthesia and minor bleeding at a trocar insertion site
Time Frame
up to 24 months follow-up
Title
Usability of the glue during the index-procedure
Description
Usability scoring: 1 = bad -> 3 = moderate -> 5 = excellent
Time Frame
Intra-operatively
Title
Technical success of glue fixation
Description
During the index-procedure, the investigator will register whether fixation of the mesh with glue achieved technical success or not. Technical success is defined as successful hernia repair as intended.
Time Frame
Intra-operatively
Title
Technical success of tack fixation
Description
During the index-procedure, the investigator will register whether fixation of the mesh with tacks achieved technical success or not. Technical success is defined as successful hernia repair as intended.
Time Frame
Intra-operatively
Title
Pain at baseline using the VAS scale
Description
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
Time Frame
At baseline
Title
Pain at discharge using the VAS scale
Description
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
Time Frame
Up to 5 days
Title
Pain at 12 months follow-up using the VAS scale
Description
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
Time Frame
At 12 months follow-up
Title
Pain at 24 months follow-up using the VAS scale
Description
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
Time Frame
At 24 months follow-up
Title
Postoperative analgesic intake
Description
Period of intake
Time Frame
Up to 24 months follow-up
Title
Postoperative analgesic intake
Description
Type of intake
Time Frame
Up to 24 months follow-up
Title
Period to return to normal activity
Description
Number of days after the index-procedure at which the patient resumes normal activities.
Time Frame
At 4 - 6 weeks follow-up
Title
Quality of life at baseline.
Description
The Carolinas Comfort Scale questionnaire is a validated, disease-specific, quality of life questionnaire developed for patients undergoing hernia repair with mesh. It is a 23-item questionnaire that measures severity of pain, sensation, and movement limitations from the mesh in eight categories. The CCS score is derived by adding the scores from each of the 23 items. The best possible score is 0 and the worst possible score is 115.
Time Frame
At baseline
Title
Quality of life at 4-6 weeks.
Description
CCS questionnaire
Time Frame
At 4 - 6 weeks follow-up
Title
Quality of life at 12 months follow-up.
Description
CCS questionnaire
Time Frame
At 12 months follow-up
Title
Quality of life at 24 months follow-up.
Description
CCS questionnaire
Time Frame
At 24 months follow-up
Title
Recurrences during follow-up
Description
A clinical examination is conducted to evaluate recurrence. If there is any suspicion of recurrence, an ultrasound or MRI is performed according to hospital practice to distinguish true recurrences from bulging.
Time Frame
up to 24 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with ventral hernia (primary or incisional) with a defect size between 2 and 5 cm and eligible for laparoscopic repair.
Patients with ASA grade I to III.
Patient is at least 18 years old.
Patient must sign and date the informed consent form prior to treatment.
Exclusion Criteria:
Patient with a recurrence of a previously treated ventral hernia repaired with mesh. Recurrences are only allowed to be included after former primary (suture) repair or retromuscular/onlay mesh repair.
Patient is treated by open surgery.
Patient has more than one defect. Treatment of Swiss-cheese defects (multiple small defects) is allowed if all defects can be treated with one mesh. Total width cannot exceed 5 cm.
Patient with a complex hernia, likely not eligible for laparoscopic repair. Complexity is determined by the investigator (adhesions, small bowel resection, etc).
Patient with a life expectancy of less than 2 years.
Patient is suspected of being unable to comply with the study protocol.
Patient with severe chronic obstructive pulmonary disease.
Patient with ASA IV or V.
Patient is pregnant.
Patient needs acute surgery.
Patient is scheduled for surgery within 6 weeks after the index-procedure.
Patient has fibromyalgia.
Patient with depression as shown in patient medical record.
Patient is enrolled in another study.
Facility Information:
Facility Name
Hospital Network Antwerp (ZNA) Jan Palfijn
City
Antwerp
Country
Belgium
Facility Name
General Hospital Sint Jan Brugge
City
Brugge
Country
Belgium
Facility Name
University Hospital Brussels
City
Brussels
Country
Belgium
Facility Name
CHU Charleroi
City
Charleroi
Country
Belgium
Facility Name
General Hospital Sint Vincentius Deinze
City
Deinze
Country
Belgium
Facility Name
ZOL Genk
City
Genk
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
Country
Belgium
Facility Name
CHR Namur
City
Namur
Country
Belgium
Facility Name
General Hospital Nikolaas
City
Sint-Niklaas
Country
Belgium
Facility Name
Regional Hospital HH Tienen
City
Tienen
Country
Belgium
Facility Name
General Hospital Delta Torhout
City
Torhout
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width
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