A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™ for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair

Study Overview
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Brief Summary
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This is a multi-center, randomized controlled trial of 284 subjects (142 in each group). Patients will be blinded to the fixation method used. The objective of this study is to compare the efficacy and safety of the LiquiBand FIX8® device to the tack-based control device (AbsorbaTack™) for laparoscopic groin hernia (inguinal or femoral) repair. The primary outcome measure is an improvement in pain score measured by VAS at 6 months. Secondary outcomes include the ability to affix hernia mesh, the ability to approximate the peritoneum, recurrence rate, and quality of life (Carolina Comfort Scale).

Official Title
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A Multi-center, Randomized, Controlled, Single Blinded, Parallel-group Study Evaluating the Clinical Performance and Safety of LiquiBand FIX8® Versus Control for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair

Conditions
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Hernia, Inguinal Hernia, Femoral Hernia, Groin Hernia

Intervention / Treatment
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* Device: LiquiBand FIX8®
* Device: AbsorbaTack™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is male or female, ≥22 years of age Is willing and able to give written informed consent Has a primary or recurrent groin hernia (unilateral or bilateral, inguinal or femoral) Is currently scheduled and eligible for TAPP or TEP laparoscopic groin hernia repair (inguinal or femoral) Hernia mesh to be used at the time of surgery is at least 4 x 6 in size and is one of the following; 3D Max™ Mesh (Bard Inc.) 3D Max™ Light (Bard Inc.) Parietex™ 2D (order code starting with TEC) Flat Sheet Mesh (Medtronic) Parietex™ 3D (order code starting with TET) Flat Sheet Mesh (Medtronic) Is willing and able to comply with the protocol assessments at time of surgery and during the post surgical follow up period Exclusion Criteria: Has a hernia type not suitable for laparoscopic hernia repair as determined by the Investigator (i.e. strangulated) Subject has a recurrent groin hernia previously repaired laparoscopically, has an anatomical defect or had prior surgical procedures that in the opinion of the Investigator prevents access to the pre-peritoneal space for TAPP or TEP laparoscopic hernia repair Is pregnant or actively breastfeeding Has a known sensitivity to cyanoacrylate or formaldehyde,D&C Violet No.2 dye or any component of LiquiBand FIX8® or control device Has an active or potential infection at the surgical site or systemic sepsis Hernia mesh to be used at surgery is less than 4x6 in size, or not one of the types of mesh listed in Inclusion Criteria above Cannot tolerate general anaesthesia Has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study

Ages Eligible for Study
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Minimum Age: 22 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 will be randomized to one of two treatment arms, LiquiBand FIX8® or Control (AbsorbaTack™) device at a 1:1 ratio. Subjects will also be randomized according to laparoscopic technique used (TEP or TAPP hernia repair procedure), so that there is appropriate distribution between the Investigational and control devices. Randomization will occur immediately prior to use of either device for mesh fixation (TEP repairs) or mesh fixation and peritoneal closure (TAPP repairs only) and only after the Investigator has laparoscopically inspected the site of repair and determined the patient to be eligible for participation in the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LiquiBand FIX8®<br>LiquiBand FIX8® is an n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye | Device: LiquiBand FIX8®<br>* An n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye<br>|
| Active Comparator: AbsorbaTack™<br>AbsorbaTack™ is an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2 | Device: AbsorbaTack™<br>* An absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the change in pain following groin hernia repair by LiquiBand FIX8® to control device as measured by Visual Analog Scale (VAS) at baseline (worst pain experienced within 1 month of screening visit) and at six months post hernia repair. | Effectiveness of LiquiBand FIX8® will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair. Success will be determined by improvement in pain not inferior to control device as measured by a VAS value. The Visual Analog Scale (VAS) consists of a straight line with the endpoints defining extreme limits, 0 = no pain and 10 = worst pain imaginable. The patient is asked to mark his/her pain level on the line between the two endpoints. | Screening from baseline (worst pain experienced within 1 month of screening) and at follow up Day 7, Day 14, Month 1, Month 3, Month 6, Month 9 and Month 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the incidence of hernia recurrence in patients following laparoscopic (TEP and TAPP) hernia repair using LiquiBand FIX8® or control device. | The incidence of hernia recurrence in patients following laparoscopic (TEP and TAPP) groin hernia repair by LiquiBand FIX8® or control (AbsorbaTack™) will be assessed by physical examination and will be confirmed by ultrasound imaging following physical examination. | Physical examination will take place at 2 weeks, 3 months and 6 months. Suspected hernia recurrence will also be evaluated at any time following surgery and up to the 12 month follow up. | 
| To compare the incidence of successful mesh fixation at the time of surgery with LiquiBand FIX8® versus control device. | LiquiBand FIX8® will be required to successfully fix hernia mesh in patients undergoing TEP and TAPP laparoscopic groin hernia repair, at a rate non-inferior to control device (AbsorbaTack™) in order to meet this end point. Successful mesh fixation would not require any additional fixation by alternate fixation device. Unsuccessful mesh fixation is defined as requiring the use of an alternative fixation device or additional procedure to achieve adequate fixation. | At the time of surgery. | 
| To compare the incidence of successful peritoneal closure (TAPP repairs only) at the time of surgery for LiquiBand FIX8® versus control device. | LiquiBand FIX8® will be required to successfully approximate the peritoneum in patients undergoing laparoscopic TAPP hernia repair, at a rate non-inferior to control devices in order to meet this end point. Successful peritoneal closure would not require any additional fixation by alternate fixation device or additional procedure. Unsuccessful peritoneal closure is defined as requiring the use of an alternative fixation device or additional procedure to achieve adequate fixation. | At the time of surgery. | 
| To evaluate the quality of life experienced by subjects following groin hernia repair by LiquiBand FIX8® or control as measured by the Carolinas Comfort Scale (CCS). | Quality of Life will be assessed by completion of the Carolinas Comfort Scale (CCS) Questionnaire (a survey used by clinicians and patients to help assess quality of life both pre and post hernia repair) following laparoscopic (TEP and TAPP) groin hernia repair. CCS scores at each timepoint will be compared between the LiquiBand FIX8® and control (AbsorbaTack) treatment groups. | Prior to surgery and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months following laparoscopic (TEP and TAPP) groin hernia repair. | 
| To compare levels of pain experienced following laparoscopic (TEP and TAPP) groin hernia repair by LiquiBand FIX8® or control device, as measured by VAS. | Evaluation of pain will be measured by VAS (0 = no pain to 10 = most pain imaginable). | At baseline (pre-surgery), discharge, and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months following surgery. | 
| To evaluate the safety of LiquiBand FIX8® and control device for groin hernia repair by comparing incidence of adverse events in patients post laparoscopic groin hernia repair. | The incidence of all adverse events whether or not determined to be related to the LiquiBand FIX8® device or control device (AbsorbaTack™) will be assessed intraoperatively, at discharge, and at each follow-up visit throughout the study, or for cause at any time in the follow up period. | Assessments will be intraoperatively, at discharge, and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months following surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoacopic, Peritoneal Closure