Robotic Versus Open Primary Ventral Hernia Repair

Robotic Versus Open Primary Ventral Hernia Repair: a Randomized Controlled Trial

Patrocinadores

Patrocinador principal: University of Geneva, Switzerland

Fuente University of Geneva, Switzerland
Resumen breve

Umbilical and epigastric hernia repair, whether considering primary or incisional hernias, are associated with a high risk of local complications, with global rate of surgical complications at one month up to 25%. To date three techniques are used.

Open ventral hernia repair (OVHR) is associated with a high risk of surgical site infection, wound dehiscence, and hematoma, but is the main technique due to advantages such as cost-effectiveness, short operative time and totally extra-peritoneal repair.

Laparoscopic hernia repair (LHR) reduces these complications but implies to place a mesh in intra-peritoneal position which is known to lead to adhesions, requires advanced laparoscopic skills, does not allow the closure of the defect due to limited range of motion, and can lead to excessive pain and pain-killers consumption due to the use of "tackers" to hold the mesh in place.

Robotic ventral hernia repair (RVHR) uses the same laparoscopic access as LHR but thanks to the extended range of motion given by the robotic system allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.

LHR is of very low adoption in Geneva University Hospital for the aforementioned inconvenient. Moreover, the final result of the procedure is not the same than with OVHR or RVHR, since the defect is not primarily closed and the mesh is in intra-peritoneal position. OVHR and RVHR , however, lead to the same final result and only defer by the access type (direct vs. laparoscopic). RVHR is gaining rapid popularity and adoption in the United States but remains a costly solution. It is unclear whether the supposed benefits for the patients of RVHR overwhelm the extra costs and time, especially by reducing the complication rate and consecutive in-hospital and out-hospital costs. Moreover, increasing experience of the robotic system in Geneva University Hospital has led to a significant costs and time reduction in other robotic procedures and could eventually make RVHR cost effective if its clinical benefits were to be proven.

This study aims at demonstrating that robotic trans-abdominal pre-peritoneal (rTAPP) primary ventral hernia repair leads to lower surgical site complication rate than the same procedure performed through standard open approach (OVHR), while being an acceptable solution from an economic, operative time and functional standpoint.

Estado general Recruiting
Fecha de inicio November 1, 2019
Fecha de Terminación November 1, 2021
Fecha de finalización primaria November 1, 2021
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Surgical site complication At 31 days after surgery
Resultado secundario
Medida Periodo de tiempo
Detailed surgical site complications At 31 days after surgery
General complications, not directly related to surgical site At 31 days after surgery
General pain: Visual Analogue Scale At 31 days after surgery
Painkillers consumption At 31 days after surgery
Esthetic satisfaction: European Hernia Society Quality of Life (EuraHS-QoL) At 31 days after surgery
Quality of life score At 31 days after surgery
In-hospital costs At day 31 after surgery
Out-hospital costs At day 31 after surgery
Early recurrence at 1 month At day 31 after surgery
Defect size During surgery
Number of device related adverse events by the operating surgeon During surgery
Inscripción 160
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Robotic ventral hernia repair

Descripción: Laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement

Etiqueta de grupo de brazo: Robotic ventral hernia repair

Tipo de intervención: Procedure

Nombre de intervención: Open ventral hernia repair

Descripción: Standard open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement

Etiqueta de grupo de brazo: Open ventral hernia repair

Elegibilidad

Criterios:

Inclusion criteria:

- Informed Consent as documented by signature

- Aged 18 years or older

- Undergoing primary umbilical or epigastric hernia repair of size between 1cm and 5cm +/-5mm, with mesh reinforcement, in the Visceral Surgery Department of the University Geneva Hospital

Exclusion Criteria:

- Patients under corticosteroids or other immunosuppressive treatment

- Pregnancy or breastfeeding

- Intention to become pregnant during the course of the study

- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential

- Incisional hernia and/or substantial history of intra-abdominal surgery

- Upon anesthesiologist evaluation, clinically significant concomitant disease states which require to shorten operative time at maximum

- Upon anesthesiologist evaluation, clinically significant concomitant disease states being a contra-indication to laparoscopic approach and/or general anesthesia

- Known or suspected non-compliance, drug or alcohol abuse,

- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the participant

- Previous enrolment into the current study

- Enrolment of the investigator, his/her family members, employees and other dependent persons

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Jonathan Douissard, MD Principal Investigator University of Geneva, Geneva University Hospital
Contacto general

Apellido: Jonathan Douissard, MD

Teléfono: 0041 79 55 33 136

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Visceral surgery department - Geneva University Hospital Jonathan Douissard, MD 0041 79 55 33 136 [email protected]
Ubicacion Paises

Switzerland

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of Geneva, Switzerland

Nombre completo del investigador: Dr Jonathan Douissard

Título del investigador: Staff surgeon visceral surgery department

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Robotic ventral hernia repair

Tipo: Active Comparator

Etiqueta: Open ventral hernia repair

Tipo: Active Comparator

Acrónimo Robovent
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Single (Participant)

Fuente: ClinicalTrials.gov