Correction of umbilical hernia with anterior muscle tissue compared to posterior muscular tissue

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2018
INTERVENTION: E04.249 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 thereof. The primary raffia of the hernia defect will be made with polypropylene 0. In the onlay technique the screen will be fixed in the anterior aponeurosis with polyglactin wire, while in the sublayer technique it will be placed in the posterior aponeurosis and fixed only in the central part by one of the points of the primary raffia . The umbilical scar will be fixed with polyglactin thread and the skin closed with 4‐0 nylon. Procedure/surgery CONDITION: K00‐K93 umbilical hernia ; K42 PRIMARY OUTCOME: 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 If it is found, it will be punctured by aseptic method, and the amount of liquid withdrawn will be recorded.; The enterocutaneous fistula will be recorded in the case of enteric contents through the surgical wound, occurring at any time during the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 OUTCOME: 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. ; INCLUSION CRITERIA: Female patients; 18 years of age or older; presenting with primary umbilical hernia.
Epistemonikos ID: cf5b3a6cf86c2ae4c42b03dc296b2e38e4ad88e9
First added on: Aug 24, 2024