Effectiveness, Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery
NCT Number: NCT06462066
Acronym: AGluTHeMFix
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inguinal and Ventral Hernia Repair by Sublay, Underlay and IPOM Mesh Fixation
Interventions: PROCEDURE: Experimental medical device|PROCEDURE: Comparator medical device
Sponsor: GEM SRL
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 101
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2020-10-19
Completion Date: 2023-06-29
Locations: Ospedale Misericordia - U.O.C Chirurgia Generale e Mini-Invasiva., Grosseto, 58100, Italy

Summary:
This pre-market, prospective, randomized, non-inferiority clinical study was designed to evaluate the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® used for mesh fixation in laparoscopic and robotic hernia surgery to obtain the indication and upgrade the medical device Glubran® Tiss 2 to class IIb.Cyanoacrylate is the generic name of a group of fast-acting adhesives such as ethyl-2-cyanoacrylate, n-butyl cyanoacrylate, 2-octy1 cyanoacrylate sold under various trade names and blend. Cyanoacrylate is a liquid acrylate monomer that polymerizes exothermically in the presence of water, especially with hydroxide ions, joining the bonded surfaces in 4-5 s and reaching the final stage in 60-90 s . It bonds body tissue excellently and shows bacteriostatic effects . The film of glue is eliminated by hydrolytic breakdown, a process whose duration varies according to tissue type and quantity .

In contrast to most cyanoacrylate glues used only for external applications as skin wound closure, Glubran® 2 is a modified n-butyl-cyanoacrylate (Glubran® 2 - N-Butyl 2 Cyanoaciylate \[NBCA\]+ Methacryloxysulfolane \[MS\]), class III medical device, CE-certified for both external and internal use .

Glubran® 2 effectiveness in repairing hernias with less post-operative pain, less complications, less hernia recurrences and a greater cost-effectiveness is largely documented . Other cyanoacrylate-based glues are authorized to fix hernia meshes, i.e.: Histoacryl (pure NBCA; classified as class IIb medical device), Liquibond FIX8 (pure NBCA; classified as class III medical device) and Ifabond (n-hexyl-cyanoacrylate; classified as class III medical device). Others are authorized to be used for specific internal indication like Omnex (2-Octyl-CyanoAcrylate \[OCA\] + Butyl-Lactoyl-Cyanoacrylate), which is indicated for use in vascular reconstructions. Sometimes, abroad, also some cyanoacrylate-based glues are applied for internal uses even if not authorized .

The present prospective and randomized study was aimed at comparing the effectiveness and safety of another cyanoacrylate-based glue called Glubran® Tiss 2 (NBCA + OCA), classified as class IIa surgical medical device, CE-marked (under the European Union \[EU\] Directive 93/42 EEC), being already authorized for use as atraumatic fixation system: Glubran® 2. Both medical devices have previously demonstrated to be well-tolerated and safe.

Glubran® 2 and Glubran® Tiss 2 were to be applied by Glutack®, a CE-marked medical device system for glue application in the surgical field. Glutack® is the related Glubran® 2/ Glubran® Tiss 2 applicator device for laparoscopic mesh fixation procedures was fabricated to offer a precise and controlled delivery of Glubran® glues .

Glubran® Tiss 2 fulfils the requirements of EU Medical Device Regulation (MDR) 2017/745 (confirmation letter received by the relative Notified Body). The composition of Glubran® Tiss 2 is obtained by mixing two different monomers of cyanoacrylate (NBCA + OCA); this gives the product a better elasticity, while maintaining high levels of tensile strength. In fact, international scientific literature has shown that the common NBCA is the cyanoacrylate molecule with the greatest tensile strength (34.27 N), low elasticity, while OCA has a lower resistance (11.27 N) but has good elastic properties. Glubran® Tiss 2 glue has a tensile strength of 27.34 N and thanks to the presence of OCA, also excellent elasticity . Among its characteristics, this formulation has haemostatic, sealing, bacteriostatic and adhesive properties. Polymerization begins 1-2 seconds after application and completes within 60 seconds. The polymerization reaction generates a temperature of approximately 45°C, which is lower than that of pure cyanoacrylates .

Glubran® Tiss 2, indicated also for use in paediatrics, is a sterile, ready for use, blended cyanacrylate adhesive to be used on the skin and mucosal tissues, which is approved as class IIa medical device, effective even in patients anticoagulated and with congenital coagulopathies .

Primary Outcome Measures: Effectiveness, A clinical examination will be conducted to evaluate recurrence. If there will be any suspicion of recurrence, an ultrasound, MRI or CT is performed according to hospital practice to distinguish true hernia recurrences from bulging. Technical success of glue fastening will be evaluated intra-operatively, the investigator will register whether mesh fixation system achieved technical success or not. Technical success is defined as successful hernia repair as intended., Verification of hernia recurrence at 1 day, 1 or 2 weeks, 3 months, 6 months
Secondary Outcome Measures: Clinical Safety:, Percentage assessment of adverse effects and events like postoperative complications including wound infection, local hematoma formation, seroma, pain, chronic pain., Verification of Clinical safety at 1 day, 1 or 2 weeks, 3 months, 6 months|Chronic pain, Chronic pain, will be defined as moderate or greater pain in the inguinal area 3 months after surgery in which the VAS pain score was ≥4. For the evaluation of pain, an analogical visual scale will be used, identical both for the pre-operative period and for subsequent monitoring timetable. VAS pain score will be determined based on a scale of 0-10 with 0 equal to no pain and 10 equal to the worse pain imaginable., Verification of chronic pain at 3 months, 6 months|Quality of the life, Assessed by the EuraHS-QoL score. It is a method to measure the quality of life for patients before (preoperative) and after (post=operative) an operation of an abdominal wall hernia with or without an implantation of a mesh to repair the defect. It is a questionnaire developed by the Working Group of the European Registry for Abdominal Wall Hernias (EuraHS). The EuraHS-QoL score is based on a Numerical Rating Scale for three dimensions:

1. pain at the site of the hernia or the hernia repair;
2. restriction of activities;
3. cosmetic discomfort;, Verification of QoL at 1 day, 1 or 2 weeks, 3 months, 6 months|Cost effectiveness, Operating time, postoperative duration of stay, hospital costs, times to ambulatory visits, re-hospitalization for severe complications, Period to return to normal activity, measured in term of number of days after the index-procedure at which the patient resumes normal activities., Verification of cost effectiveness at 1 day, 1 or 2 weeks, 3 months, 6 months|Appropriateness, Appropriateness of the glue fixation system for prosthetic fixing (mesh) GLUTACK-Glubran® Tiss 2 and Glubran® assessed by the technical success of fixing the product, evaluated intra-operatively. The investigator will record if the glue fixation system for fixing the prosthesis (mesh) GLUTACK has achieved technical success or not. "Proper Use" is defined as the successful completion of all the following five steps:

1. Attaching the cannula to handle properly;
2. Positioning correctly the GLUTACK® device for procedure as per the user manual's instructions;
3. Using the device's control button correctly for suitable application;
4. Placing the cannula tip correctly at the surgical opening;
5. Using the device for up to but not exceeding 60 seconds., Verification of Appropriateness at Intervention day during the procedure