Femoral Hernia, Groin Hernia, Hernia, Inguinal Hernia
Conditions
Keywords
Laparoacopic, Peritoneal Closure
Brief summary
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).
Interventions
DEVICELiquiBand FIX8®
An n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye
DEVICEAbsorbaTack™
An absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2.
Sponsors
Advanced Medical Solutions Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Randomization to either Investigational or control device will occur at the surgery visit. The patients will be blinded to their randomly assigned treatment device prior to surgery and during the follow up period following surgery. While it is not possible to blind investigators/staff members to the treatment device used, Investigators and staff members will not learn of randomized device until immediately prior to use of device, so as to maintain subject blinding prior to the hernia repair. Investigators and staff members will be asked to maintain subject blinding through the course of the follow up visits so as to not bias subject feedback on applicable study assessments. Patients will receive the same standard of care prior to, during and following surgery regardless of randomized device assignment, and therefore will not be able to individually determine what device they have been randomized to.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | Assessed at pre-surgery (baseline), day 7, day 14, month 1, month 3 and month 6 post surgery. Change from baseline at month 6 reported. | Change in pain from baseline to 6 month will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Mesh Fixation at the Time of Surgery. | Time of surgery. | LiquiBand FIX8® was required to successfully fix hernia mesh at a rate non-inferior to control device (AbsorbaTack™). Successful mesh fixation did not require any additional fixation by alternate fixation device. |
| Incidence of Successful Peritoneal Closure (TAPP Repairs Only) | Time of surgery. | LiquiBand FIX8® was required to successfully approximate the peritoneum at a rate non-inferior to control device. Successful peritoneal closure did not require any additional fixation by alternate fixation device or additional procedure. |
| Number of Participants With Hernia Recurrence | Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported | The incidence of hernia recurrence was assessed by physical examination and confirmed by ultrasound imaging following physical examination. Also, the study sites were guided to ask the subjects 3 questions during the clinic visit performed remotely with a 'Yes' or 'No' response; 1. Do you think your hernia has come back? 2. Do you feel or see a bulge? and 3. Do you have physical pain or symptoms at the site? |
| Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Evaluation of pain will be measured at pre-surgery, discharge (up to 3 days), Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery | A Visual Analog Scale (VAS) was used as a measure of pain where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable. |
| Safety as Measured by the Incidence of Adverse Events. | Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery | The number of all adverse events whether or not determined to be related to the LiquiBand FIX8® device or control device (AbsorbaTack™). |
| Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery | Quality of Life was assessed by completion of the Carolinas Comfort Scale (CCS) Questionnaire. CCS scores at each timepoint were compared between the LiquiBand FIX8® and control (AbsorbaTack) treatment groups. Carolinas Comfort Scale measures quality of life through a 23-item, Likert-type questionnaire that measures severity of pain, sensation of mesh and movement limitations in eight categories: laying down, bending over, sitting up, activities of daily living, coughing or deep breathing, walking, stairs and exercise. The subscales scores for pain (0-40), sensation of mesh (0-40) and movement limitations (0-35) are combined to provide a total CCS score. The best possible score is 0 and the worst possible score is 115. |
Countries
United States
Participant flow
Recruitment details
Between August 2019 and December 2021, 329 patients were screened and consented for laparoscopic groin (femoral and inguinal). Of those Subjects 142 were randomized to LiquiBand Fix8 and 142 were randomized to AbsorbaTack for mesh fixation and peritoneal closure (in the case of TAPP).
Participants by arm
| Arm | Count |
|---|---|
| LiquiBand FIX8® Groin Hernia Study Arm with LiquiBand FIX8® as treatment | 142 |
| AbsorbaTack™ Groin Hernia Study Arm with AbsorbaTack™ as treatment | 142 |
| Total | 284 |
Baseline characteristics
| Characteristic | LiquiBand FIX8® | Total | AbsorbaTack™ |
|---|---|---|---|
| Age, Continuous | 59.41 years STANDARD_DEVIATION 13.696 | 58.94 years STANDARD_DEVIATION 14.041 | 58.47 years STANDARD_DEVIATION 14.411 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 276 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 29 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 128 Participants | 249 Participants | 121 Participants |
| Region of Enrollment United States | 142 participants | 284 participants | 142 participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 4 Participants |
| Sex: Female, Male Male | 132 Participants | 270 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 142 | 0 / 142 |
| other Total, other adverse events | 28 / 142 | 49 / 142 |
| serious Total, serious adverse events | 11 / 142 | 16 / 142 |
Outcome results
Primary
Change in Pain
Change in pain from baseline to 6 month will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.
Time frame: Assessed at pre-surgery (baseline), day 7, day 14, month 1, month 3 and month 6 post surgery. Change from baseline at month 6 reported.
Population: ITT population defined as all enrolled subjects. All patients for whom VAS measurements were recorded at Baseline and 6 month post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LiquiBand FIX8® | Change in Pain | -4.9 score on a VAS scale | Standard Deviation 2.5 |
| AbsorbaTack™ | Change in Pain | -5.1 score on a VAS scale | Standard Deviation 2.3 |
p-value: <0.025ANCOVA
Secondary
Incidence of Successful Peritoneal Closure (TAPP Repairs Only)
LiquiBand FIX8® was required to successfully approximate the peritoneum at a rate non-inferior to control device. Successful peritoneal closure did not require any additional fixation by alternate fixation device or additional procedure.
Time frame: Time of surgery.
Population: ITT Population. Successful peritoneal closure at time of surgery was measured in all subjects undergoing TAPP hernia repair.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LiquiBand FIX8® | Incidence of Successful Peritoneal Closure (TAPP Repairs Only) | 82 Participants |
| AbsorbaTack™ | Incidence of Successful Peritoneal Closure (TAPP Repairs Only) | 84 Participants |
p-value: <0.025Farrington-Manning
Secondary
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS).
A Visual Analog Scale (VAS) was used as a measure of pain where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.
Time frame: Evaluation of pain will be measured at pre-surgery, discharge (up to 3 days), Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Population: ITT population defined as all enrolled subjects. All patients for whom VAS measurements were recorded at discharge, and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months post-surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiquiBand FIX8® | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to discharge | -0.3 score on a scale | Standard Deviation 3.4 |
| LiquiBand FIX8® | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 1 week | -1.5 score on a scale | Standard Deviation 2.8 |
| LiquiBand FIX8® | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 2 weeks | -2.8 score on a scale | Standard Deviation 2.8 |
| LiquiBand FIX8® | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 1 month | -3.2 score on a scale | Standard Deviation 2.8 |
| LiquiBand FIX8® | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 3 months | -3.6 score on a scale | Standard Deviation 2.9 |
| LiquiBand FIX8® | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 6 months | -3.6 score on a scale | Standard Deviation 3 |
| LiquiBand FIX8® | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 9 months | -3.7 score on a scale | Standard Deviation 2.9 |
| LiquiBand FIX8® | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 12 months | -3.6 score on a scale | Standard Deviation 2.9 |
| AbsorbaTack™ | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 12 months | -3.5 score on a scale | Standard Deviation 3.1 |
| AbsorbaTack™ | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to discharge | -0.1 score on a scale | Standard Deviation 3.5 |
| AbsorbaTack™ | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 3 months | -3.4 score on a scale | Standard Deviation 3.1 |
| AbsorbaTack™ | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 1 week | -1.5 score on a scale | Standard Deviation 3.1 |
| AbsorbaTack™ | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 9 months | -3.5 score on a scale | Standard Deviation 3 |
| AbsorbaTack™ | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 2 weeks | -2.7 score on a scale | Standard Deviation 2.9 |
| AbsorbaTack™ | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 6 months | -3.5 score on a scale | Standard Deviation 3.1 |
| AbsorbaTack™ | Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). | Change from pre-surgery to 1 month | -3.1 score on a scale | Standard Deviation 3.1 |
Secondary
Number of Participants With Hernia Recurrence
The incidence of hernia recurrence was assessed by physical examination and confirmed by ultrasound imaging following physical examination. Also, the study sites were guided to ask the subjects 3 questions during the clinic visit performed remotely with a 'Yes' or 'No' response; 1. Do you think your hernia has come back? 2. Do you feel or see a bulge? and 3. Do you have physical pain or symptoms at the site?
Time frame: Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported
Population: ITT population defined as all enrolled subjects. All patients who attended their follow up visit and underwent a physical examination where possible, or alternatively with self-assessment for hernia recurrence.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LiquiBand FIX8® | Number of Participants With Hernia Recurrence | 1 Participants |
| AbsorbaTack™ | Number of Participants With Hernia Recurrence | 2 Participants |
p-value: <0.025Farrington-Manning
Secondary
Quality of Life as Measured by the Carolinas Comfort Scale (CCS).
Quality of Life was assessed by completion of the Carolinas Comfort Scale (CCS) Questionnaire. CCS scores at each timepoint were compared between the LiquiBand FIX8® and control (AbsorbaTack) treatment groups. Carolinas Comfort Scale measures quality of life through a 23-item, Likert-type questionnaire that measures severity of pain, sensation of mesh and movement limitations in eight categories: laying down, bending over, sitting up, activities of daily living, coughing or deep breathing, walking, stairs and exercise. The subscales scores for pain (0-40), sensation of mesh (0-40) and movement limitations (0-35) are combined to provide a total CCS score. The best possible score is 0 and the worst possible score is 115.
Time frame: Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Population: ITT population defined as all enrolled Subjects. All patients for whom a CCS questionnaire was completed prior to surgery and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months post surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiquiBand FIX8® | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 2 weeks | -7.7 score on a scale | Standard Deviation 12.4 |
| LiquiBand FIX8® | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 1 month | -12.4 score on a scale | Standard Deviation 12.6 |
| LiquiBand FIX8® | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 3 months | -14.6 score on a scale | Standard Deviation 16.9 |
| LiquiBand FIX8® | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 6 months | -15.1 score on a scale | Standard Deviation 16 |
| LiquiBand FIX8® | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 9 months | -15.6 score on a scale | Standard Deviation 16.3 |
| LiquiBand FIX8® | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 12 months | -15.6 score on a scale | Standard Deviation 16 |
| AbsorbaTack™ | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 9 months | -15.7 score on a scale | Standard Deviation 16.5 |
| AbsorbaTack™ | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 2 weeks | -7.0 score on a scale | Standard Deviation 13.2 |
| AbsorbaTack™ | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 6 months | -15.3 score on a scale | Standard Deviation 16.7 |
| AbsorbaTack™ | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 1 month | -12.2 score on a scale | Standard Deviation 14.6 |
| AbsorbaTack™ | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 12 months | -15.3 score on a scale | Standard Deviation 16.1 |
| AbsorbaTack™ | Quality of Life as Measured by the Carolinas Comfort Scale (CCS). | Change from 1 week to 3 months | -14.4 score on a scale | Standard Deviation 15.9 |
Secondary
Safety as Measured by the Incidence of Adverse Events.
The number of all adverse events whether or not determined to be related to the LiquiBand FIX8® device or control device (AbsorbaTack™).
Time frame: Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LiquiBand FIX8® | Safety as Measured by the Incidence of Adverse Events. | 114 Adverse Events |
| AbsorbaTack™ | Safety as Measured by the Incidence of Adverse Events. | 157 Adverse Events |
Secondary
Successful Mesh Fixation at the Time of Surgery.
LiquiBand FIX8® was required to successfully fix hernia mesh at a rate non-inferior to control device (AbsorbaTack™). Successful mesh fixation did not require any additional fixation by alternate fixation device.
Time frame: Time of surgery.
Population: All Subjects who underwent surgery with LiquiBand FIX8® or control
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LiquiBand FIX8® | Successful Mesh Fixation at the Time of Surgery. | 142 Participants |
| AbsorbaTack™ | Successful Mesh Fixation at the Time of Surgery. | 142 Participants |
p-value: <0.025Farrington-Manning