Incisional Hernia, Elective Surgical Procedures, Laparoscopy
Conditions
Interventions
This is a controlled randomized clinical trial, partially blinded, conducted at Hospital Edmundo Vasconcelos. The study will compare the incidence of postoperative incisional hernia in patients underg
Sponsors
Hospital Professor Edmundo Vasconcelos
Hospital Professor Edmundo Vasconcelos
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Adults (>18 years) undergoing elective or urgent video-laparoscopic cholecystectomy or inguinal hernia repair; BMI < 35 kg/m²; Signed informed consent
Exclusion criteria
Exclusion criteria: Pre-existing/large umbilical hernias; converted surgeries; pregnant women; immunocompromised patients; collagenoses; local infection; contraindication to video-laparoscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected lower incidence in incisional hernia in Polydioxanone suture group in less than 5% in the period of one year (with visits in the 1, 3, 6 and 12 month after the procedure). Data colected with examination by an assistant and from ultrasound or other images if necessary after 6 months and after 12 months after procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Identify early complications (infection, seroma, dehiscence); late complications (chronic pain, granuloma); Compare abdominal pain across different periods; Correlate the incidence of incisional hernia with comorbidities (BMI, diabetes, smoking); Differentiate costs between the materials | — |
Countries
Brazil
Contacts
Public ContactHeitor Lopes
Hospital Edmundo Vasconcelos
Outcome results
None listed