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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquiband Fix8 glue mesh fixation | Active Comparator |
| |
| Mesh fixation with absorbable tacks | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquiband Fix8 | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Period of hospitalization | Record the number of days in hospital until discharge | up to 5 days |
| Operating time | Intra-operatively | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Network Antwerp (ZNA) Jan Palfijn | Antwerp | Belgium | ||||
| General Hospital Sint Jan Brugge |
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Patients are randomly allocated to group 1 or group 2:
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|
| Absorbable tack | Device | Absorbable tack |
|
| 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 |
| Bruges |
| Belgium |
| University Hospital Brussels | Brussels | Belgium |
| CHU Charleroi | Charleroi | Belgium |
| General Hospital Sint Vincentius Deinze | Deinze | Belgium |
| ZOL Genk | Genk | Belgium |
| University Hospital Leuven | Leuven | Belgium |
| CHR Namur | Namur | Belgium |
| General Hospital Nikolaas | Sint-Niklaas | Belgium |
| Regional Hospital HH Tienen | Tienen | Belgium |
| General Hospital Delta Torhout | Torhout | Belgium |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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