RBR-4n4c4z Correction of umbilical hernia with anterior muscle tissue compared to posterior muscular tissue

Date of registration: 03/27/2018 ^(mm/dd/yyyy)
Last approval date : 03/27/2018 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1205-0065

• Public title:

  en

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

  pt-br

  Correção da hérnia umbilical com tela muscular anterior comparada a tela muscular posterior

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 66593817.5.0000.5329
    Issuing authority: Plataforma Brasil
  • 2.146.387
    Issuing authority: Comitê de Ética em Pesquisa do Hospital Materno Infantil Presidente Vargas

Sponsors

• Primary sponsor: Hospital Presidente Vargas
• Secondary sponsor:
  • Institution: Hospital Presidente Vargas
• Supporting source:
  • Institution: Hospital Presidente Vargas

Health conditions

• Health conditions:

  en

  umbilical hernia

  pt-br

  hérnia umbilical

• General descriptors for health conditions:

  en

  K00-K93 XI - Diseases of the digestive system

  pt-br

  K00-K93 XI - Doenças do aparelho digestivo

• Specific descriptors:

Interventions

• Interventions:

  en

  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.

  pt-br

  As pacientes com hérnia umbilical serão randomizadas para a realização de hernioplastia onlay (n 73) ou sublay (n 73). Todas as pacientes serão submetidas a incisão supra ou infraumbilical, disseção do saco herniário e redução do mesmo. A rafia primária do defeito herniário será realizada com fio de polipropileno 0. Na técnica onlay a tela será fixada na aponeurose anterior com fio poliglactina, enquanto na técnica sublay será colocada na aponeurose posterior e fixada apenas na parte central por um dos pontos da rafia primária. A cicatriz umbilical será fixada com fio de poliglactina e a pele fechada com fio de nylon 4-0.

• Descriptors:

  en

  E04.249 Elective Surgical Procedures

  pt-br

  E04.249 Procedimentos Cirúrgicos Eletivos

  es

  E04.249 Procedimientos Quirúrgicos Electivos

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 10/01/2017 ^(mm/dd/yyyy)
• Date last enrollment: 12/30/2019 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  146	F	18 Y	100 Y

• Inclusion criteria:

  en

  Female patients; 18 years of age or older; presenting with primary umbilical hernia.

  pt-br

  Pacientes do sexo feminino; com 18 anos ou mais; apresentando hérnia umbilical primária.

• Exclusion criteria:

  en

  Patients with relapsed umbilical hernia; need for another concomitant surgical procedure.

  pt-br

  Pacientes com hérnia umbilical recidivada; necessidade de outro procedimento cirúrgico concomitante.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Single-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  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.

  pt-br

  O desfecho primário será a ocorrência de eventos no sítio cirúrgico (Surgical-Site Occurrence - SSO), descritos pelo Ventral Hernia Working Group (VHWG): infecção, deiscência de sutura, seroma ou fístula enterocutânea. A infecção de ferida operatória será definida como a que ocorrer nos primeiros 30 dias da cirurgia, envolvendo apenas a pele e o tecido subcutâneo, apresentando, pelo menos, um dos seguintes sinais e sintomas: dor, aumento de sensibilidade, eritema, calor local e secreção purulenta. A deiscência da sutura será caracterizada pelo afastamento dos bordos da ferida operatória nos primeiros 30 dias de pós-operatório. O seroma será definido como acúmulo de secreção não purulenta sob a ferida operatória, de aspecto serosanguinolento. Caso o mesmo seja constatado, ele será puncionado por método asséptico, e a quantidade de líquido retirado será registrada. A fístula enterocutânea será registrada caso haja saída de conteúdo entérico através da ferida operatória, ocorrendo a qualquer tempo no período de seguimento do estudo.

• Secondary outcomes:

  en

  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.

  pt-br

  Desfecho secundário 1: A dor será avaliada através da através da Escala Análoga Visual, que varia de 0 a 10, sendo 10 a dor mais severa já sentida pelo paciente e 0 a ausência de dor. Esta variável será registrada em todas as consultas de pós-operatório. Dor crônica será aquela que persistir após três meses do procedimento cirúrgico. Também será registrado o tempo de retorno as atividades cotidianas.

  en

  Secondary outcome 2: Recurrence of umbilical hernia will be assessed by physical examination.

  pt-br

  Desfecho secundário 2: A recidiva da hérnia umbilical será avaliada através do exame físico.

Contacts

• Public contact
  • Full name: Lissandro Tarso
  • • Address: Av. Independência, 661
    • City: Porto Alegre / Brazil
    • Zip code: 90035-074
  • Phone: +5551999774962
  • Email: lissandrotarso@hotmail.com
  • Affiliation: Hospital Presidente Vargas
   
• Scientific contact
  • Full name: Lissandro Tarso
  • • Address: Av. Independência, 661
    • City: Porto Alegre / Brazil
    • Zip code: 90035-074
  • Phone: +5551999774962
  • Email: lissandrotarso@hotmail.com
  • Affiliation: Hospital Presidente Vargas
   
• Site contact
  • Full name: Lissandro Tarso
  • • Address: Av. Independência, 661
    • City: Porto Alegre / Brazil
    • Zip code: 90035-074
  • Phone: +5551999774962
  • Email: lissandrotarso@hotmail.com
  • Affiliation: Hospital Presidente Vargas
   

Additional links:

• Download in ICTRP format