This was a pre-market, prospective, randomized, non-inferiority, clinical study aimed at evaluating the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® 2 applied for mesh fastening in laparoscopic and robotic hernia surgery to get the indication and upgrade Glubran® Tiss 2 to class IIb. The study was conducted in seven centres in Italy and was to enroll 100 patients. Patients were to be followed for 6 months. The global duration of the trial was approximately 32 months.
According to the CIP, 6 Visits were planned over the perioperative/post operative period for each patient (after 24 hours,7, 14, 90, and 180 days).
At Visit 1 (V1, day 0, Baseline visit), patients were requested to sign the written informed consent before any procedure was performed. Patients were screened for eligibility for the study ascertaining that all inclusion criteria and no exclusion criteria were met. At V1, the Investigator recorded demographic and medical history, basal clinical assessment data and performed full physical examination and evaluation of clinical signs/symptoms.
Patients were randomly assigned (1:1 allocation ratio) to one of the two treatment groups: Glutack-Glubran® system (Group 1) or Glutack-Glubran® Tiss 2 (Group 2). The application of Glutack-Glubran® system or Glutack-Glubran® Tiss 2 was performed by the investigator, after a previous appropriate training on how to assemble/use each device.
Technical success of glue fastening was evaluated intra-operatively, the investigator registered whether mesh fixation system achieved technical success or not. Technical success was to be defined as successful hernia repair as intended, but actually defined in the present analysis as a surgical procedure with no complications within the first 24 hours after surgery and a surgeon's rating for Efficacy and Control greater than or equal to 4.At specific intervals, at V2 (24 hours), V3 (7 days), V4 (14 days), V5 (90 days) and V6 (180 days), patients were requested to return to the centre for the clinical assessments of safety, quality of life and effectiveness. As regards effectiveness, at each Visit, the area of the mesh implant was evaluated for recurrence through a specific abdominal clinical examination. In case of any suspicion of recurrence, an ultrasound or MRI was to be performed according to hospital practice to distinguish true hernia recurrences from bulging. At V6 cost effectiveness was also to be evaluated.The primary objective of the study was to assess the effectiveness of Glutack-Glubran® Tiss 2 mesh fastening in comparison with mesh fixation by Glutack-Glubran® 2 evaluated in terms of hernia recurrence rate after surgery and technical success of glue fastening (evaluated intra-operatively).
The secondary objectives were aimed at investigating the following:
1. Safety in terms of side effects
2. Cost effectiveness in terms of direct costs of intervention, operating and hospitalization times, times of return to normal activity
3. The adequacy of Glutack® medical device for the application of surgical glue for fixing the prosthesis (mesh) in terms of ease of use and satisfaction of the surgeon.
This study enrolled 107 adult patients submitted to surgical treatment for laparoceles (incisional hernia) or monolateral or bilateral inguinal hernia.
6.3.1 Inclusion Criteria
Patients could be enrolled in the investigation if they met all the following inclusion criteria:
1. No significant cardiopulmonary, hepatic, or renal impairment, and no contraindications for surgery;
2. Clinical diagnosis of:
1. bilateral inguinal hernia eligible for minimally invasive repair (TAPP-TEP VLS/ROB)
2. recurrent monoliteral inguinal hernia (TAPP-TEP VLS/ROB)
3. large inguinoscrotal hernias (TAPP-TEP ROB)
4. primary ventral hernia with defects size ≤ 7cm (IPOM-TARUP-COSTA-THT-MILOS-eMILOS VLS/ROB)
5. primary abdominal border hernia (idem VLS/ROB)
6. post-incisional hernia with defect size ≤ 7cm (idem VLS)
7. post-incisional hernia and complex abdomen (RIVES-RIVES+TAR ROB)
8. Swiss-cheese defects multiple small defects if treatable with only one mesh; if the total width of the defect is ≤ 5cm will be repaired by IPOM VLSM; if it is \> 5cm will be repaired by RIVES-RIVES+TAR ROB;
3. Age \> 18 years, male and Female;
4. Obese patient (BMI\>35);
5. Patients with ASA grade from I to III;
6. Patients must sign and date the informed consent form prior to treatment. 6.3.2 Exclusion Criteria
Patients could not be enrolled in the investigation if they met any of the following exclusion criteria:
1. Incarcerated hernia;
2. Allergy to multiple classes of drugs, recent allergic disease, or use of drugs that are known harmful to vital organs during the 4 weeks before surgery;
3. Patients with ASA IV or V;
4. Participations in other clinical studies in the 3 months before surgery;
5. Atopic allergy history;
6. Mental illness history;
7. Diseases that may significantly increase Intra-Abdominal Pressure (IAP) and cannot be effectively controlled such as severe ascites, severe asthma caused by bronchitis, pulmonary emphysema, or urine retention caused by significant Benign Prostatic Hyperplasia (BPH);
8. Infection located at the surgical site or bacteraemia;
9. Patients with collagenopathies;
10. Relevant other concurrent diseases;
11. Patient with neurological disorders and/or mood disorders;
12. Hyperemotional patients;
13. Pregnant women.
