Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width

Study Overview
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Brief Summary
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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.

Official Title
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Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width: a Multicenter Randomized Controlled Study

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Liquiband Fix8
* Device: Absorbable tack


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liquiband Fix8 glue mesh fixation<br> | Device: Liquiband Fix8<br>* 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.<br>|
| Active Comparator: Mesh fixation with absorbable tacks<br> | Device: Absorbable tack<br>* Absorbable tack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 4 - 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period of hospitalization | Record the number of days in hospital until discharge | up to 5 days | 
| Operating time |  | Intra-operatively | 
| Intra-operative adverse events | Intra-operative adverse events include bleeding and enterotomy | Intra-operatively | 
| 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 | up to 24 months follow-up | 
| Usability of the glue during the index-procedure | Usability scoring: 1 = bad -> 3 = moderate -> 5 = excellent | Intra-operatively | 
| 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. | Intra-operatively | 
| 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. | Intra-operatively | 
| 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. | At baseline | 
| 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. | Up to 5 days | 
| 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. | At 12 months follow-up | 
| 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. | At 24 months follow-up | 
| Postoperative analgesic intake | Period of intake | Up to 24 months follow-up | 
| Postoperative analgesic intake | Type of intake | Up to 24 months follow-up | 
| Period to return to normal activity | Number of days after the index-procedure at which the patient resumes normal activities. | At 4 - 6 weeks follow-up | 
| 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. | At baseline | 
| Quality of life at 4-6 weeks. | CCS questionnaire | At 4 - 6 weeks follow-up | 
| Quality of life at 12 months follow-up. | CCS questionnaire | At 12 months follow-up | 
| Quality of life at 24 months follow-up. | CCS questionnaire | At 24 months follow-up | 
| 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. | up to 24 months follow-up |