Randomized controlled trial to evaluate the feasibility and effectiveness of anti-adherent agent [Guardix-SG®(Poloxamer/alginate)] after inguinal herniorrhaphy (pilot study)

Not Applicable

• Conditions: Diseases of the digestive system

• Registration Number: KCT0007398
• Lead Sponsor: The Catholic University of Korea, St. Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Comparison of postoperative complication rate in patients with and without Guardix-SG application.