None listed
Conditions
Interventions
Medical Device : 1. Medical device: Guardix-SG (Medical device grade 3)
1) Intended use: Guardix SG is indicated as an adjuvant to prevent or reduce the post-surgical adhesion formation in patient u
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 19 to 74 years old. 2. Patient who diagnosed the inguinal hernia. (Indirect inguinal hernia, direct inguinal hernia) 3. Patients scheduled for laparoscopic and robotic hernia surgery. 4. ASA score 1-3 5. ECOG performance status 1-2 6. Patient who understands and agrees to the purpose of the study and has consented to participate.
Exclusion criteria
Exclusion criteria: 1. Patients under 18 years of age and over 76 years of age. 2. Female patients who are pregnant or plan to become pregnant during the study period. 3. ASA score =4 4. ECOG performance status =3 5. Patients with a history of inguinal hernia surgery on the same side. 6. Patients who are finally diagnosed with femoral or obturator hernia after surgery. 7. Patients with neurologic disorders. 8. Patients with a history of allergic reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the degree of the pain score at the inguinal area caused by adhesion between patients who had applied Guardix-SG® (Poloxamer/alginate) to the surgical site after hernial sac reduction and those who did not. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of postoperative complication rate in patients with and without Guardix-SG application. | — |
Countries
Korea, Republic of
Contacts
Public ContactJi Yeon Mun
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed