Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT06462066
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06462066
Study Brief:
Protocol Section:
NCT06462066