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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03429374
Other study ID # BLITS-01
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 19, 2018
Est. completion date May 20, 2021

Study information

Verified date May 2021
Source Duomed
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date May 20, 2021
Est. primary completion date May 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patient with ventral hernia (primary or incisional) with a defect size between 2 and 5 cm and eligible for laparoscopic repair. 2. Patients with ASA grade I to III. 3. Patient is at least 18 years old. 4. Patient must sign and date the informed consent form prior to treatment. Exclusion Criteria: 1. 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. 2. Patient is treated by open surgery. 3. 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. 4. Patient with a complex hernia, likely not eligible for laparoscopic repair. Complexity is determined by the investigator (adhesions, small bowel resection, etc). 5. Patient with a life expectancy of less than 2 years. 6. Patient is suspected of being unable to comply with the study protocol. 7. Patient with severe chronic obstructive pulmonary disease. 8. Patient with ASA IV or V. 9. Patient is pregnant. 10. Patient needs acute surgery. 11. Patient is scheduled for surgery within 6 weeks after the index-procedure. 12. Patient has fibromyalgia. 13. Patient with depression as shown in patient medical record. 14. Patient is enrolled in another study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Liquiband Fix8
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.
Absorbable tack
Absorbable tack

Locations

Country Name City State
Belgium Hospital Network Antwerp (ZNA) Jan Palfijn Antwerp
Belgium General Hospital Sint Jan Brugge Brugge
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

Sponsors (1)

Lead Sponsor Collaborator
Duomed

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Period of hospitalization Record the number of days in hospital until discharge up to 5 days
Secondary Operating time Intra-operatively
Secondary Intra-operative adverse events Intra-operative adverse events include bleeding and enterotomy Intra-operatively
Secondary 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
Secondary Usability of the glue during the index-procedure Usability scoring: 1 = bad -> 3 = moderate -> 5 = excellent Intra-operatively
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Postoperative analgesic intake Period of intake Up to 24 months follow-up
Secondary Postoperative analgesic intake Type of intake Up to 24 months follow-up
Secondary 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
Secondary 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
Secondary Quality of life at 4-6 weeks. CCS questionnaire At 4 - 6 weeks follow-up
Secondary Quality of life at 12 months follow-up. CCS questionnaire At 12 months follow-up
Secondary Quality of life at 24 months follow-up. CCS questionnaire At 24 months follow-up
Secondary 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
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