umbilical hernia
Conditions
Interventions
Patients with umbilical hernia will be randomized to perform onlay (n 73) or sublay (n 73) hernioplasty. All patients will be submitted to a supra or infraumbilical incision, hernia sac and reduction
Procedure/surgery
Sponsors
Hospital Presidente Vargas
Hospital Presidente Vargas
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Female patients; 18 years of age or older; presenting with primary umbilical hernia.
Exclusion criteria
Exclusion criteria: Patients with relapsed umbilical hernia; need for another concomitant surgical procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the occurrence of surgical site events (Surgical-Site Occurrence - SSO) described by Ventral Hernia Working Group (VHWG): infection, suture dehiscence, seroma, or enterocutaneous fistula. The surgical wound infection will be defined as that occurring within the first 30 days of surgery, involving only the skin and the subcutaneous tissue, presenting at least one of the following signs and symptoms: pain, increased sensitivity, erythema, local heat and purulent secretion. The dehiscence of the suture will be characterized by the removal of the edges of the surgical wound in the first 30 postoperative days. The seroma will be defined as accumulation of non-purulent secretion under the operative wound, with serosanguinolent appearance. If it is found, it will be punctured by aseptic method, and the amount of liquid withdrawn will be recorded. The enterocutaneous fistula will be recorded in the case of enteric contents through the surgical wound, occurring at any time during the period of follow-up of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain will be assessed through the Visual Analogue Scale, which ranges from 0 to 10, with 10 being the most severe pain experienced by the patient and 0 being painless. This variable will be recorded in all postoperative consultations. Chronic pain will be one that persists after three months of the surgical procedure. Also will be recorded the return time to daily activities. ;Secondary outcome 2: Recurrence of umbilical hernia will be assessed by physical examination. | — |
Countries
Brazil
Contacts
Public ContactLissandro Tarso
Hospital Presidente Vargas
Outcome results
None listed