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

Ventral Hernia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03429374
• Other study ID #: BLITS-01
• Status: Terminated
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

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