AGluTHeMFixComparison of GLUTACK-Glubran® Tiss 2 and GLUTACK-Glubran® 2 for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery
This study aims to compare the effectiveness of GLUTACK-Glubran® Tiss 2 and GLUTACK-Glubran® 2 for mesh fastening in laparoscopic and robotic hernia surgery, focusing on technical success and hernia recurrence.
Experimental medical device
+ Comparator medical device
Other Study
Summary
Study start date: October 19, 2020
Actual date on which the first participant was enrolled.This clinical study investigates the effectiveness and safety of two different glue systems, Glutack-Glubran® Tiss 2 and Glutack-Glubran® 2, used for securing surgical mesh during hernia repair surgeries. The study focuses on patients undergoing laparoscopic or robotic hernia surgery for various types of hernias, such as incisional or inguinal hernias. Conducted across seven centers in Italy, the study aims to enroll 100 patients to determine if Glutack-Glubran® Tiss 2 is as effective and safe as the existing Glutack-Glubran® 2 system. The primary goal is to evaluate the rate of hernia recurrence and the technical success of the glue fastening compared to the current method. This research is important as it may lead to improved surgical outcomes and provide a new treatment option for patients with hernias. Participants in the study are randomly assigned to receive either the Glutack-Glubran® Tiss 2 or Glutack-Glubran® 2 glue system during their surgery. The process involves the surgeon applying the glue to fix the mesh in place. The study measures the technical success of the procedure by checking for complications within the first 24 hours post-surgery and assessing the surgeon's satisfaction. Follow-up visits are conducted over a six-month period to monitor the patients' recovery and to check for any signs of hernia recurrence. The study also assesses safety by recording any side effects, as well as cost-effectiveness by evaluating the costs associated with the surgery and recovery times. This comprehensive approach helps ensure that the new glue system is both safe and effective for use in hernia surgeries.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.101 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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. 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Ospedale Misericordia - U.O.C Chirurgia Generale e Mini-Invasiva.
Grosseto, ItalyOpen Ospedale Misericordia - U.O.C Chirurgia Generale e Mini-Invasiva. in Google Maps