A Multicenter Belgian Trial of Ventral Hernia Repair (UNITE)
Ventral Hernia
About this trial
This is an interventional other trial for Ventral Hernia focused on measuring ventral hernia
Eligibility Criteria
Inclusion Criteria:
- Patient with incisional midline ventral hernia (M2: epigastric, M3: umbilical, M4: infra-umbilical) with a minimal width of 3 cm and a maximum width of 8 cm. Multiple hernia defects (Swiss cheese) are allowed according to European Hernia Society (EHS) classification (Appendix 1).
- Recurrences are only allowed to be included after former primary repair (suture repair without mesh).
- Patients with ASA grade I to III.
- Patient is at least 18 years old.
- Patient must sign and date the informed consent form prior to treatment.
- Patient is able to tolerate general anesthesia.
Exclusion Criteria:
- Patient with a life expectancy of less than 2 years.
- Patient is suspected of being unable to comply with the study protocol.
- Patient is pregnant.
- Patient needs acute surgery.
- Patient is enrolled in another study.
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Laparoscopic ventral hernia repair with closure of the defect
Open ventral hernia repair with closure of the defect
Robotic ventral hernia repair with closure of the defect
In laparoscopic intraperitoneal onlay mesh or IPOM repair, the mesh is inserted intra-abdominally and fixed to the peritoneum / abdominal wall. The general steps include safe entry into the peritoneum, insufflation and placement of the trocars to gain access and visibility (via laparoscope) of the defect. Careful adhesiolysis is performed, which is the removal of scar tissue connecting tissues and organs. The content of the hernia, which may include intestine and fatty tissue, is returned into the abdominal cavity. After closure of the hernia defect, a wide intraperitoneal mesh is fixed over the defect. Desufflation releases the gas from the abdomen. The trocars will be removed and the incisions are closed.
An open retromuscular ventral hernia repair involves an incision through the abdominal wall. Adhesiolysis is performed and the content of the hernia is returned into the abdominal cavity. The posterior rectus sheath is separated from the rectus muscle and closed, which closes the abdominal cavity. The mesh is then placed behind the muscle and anterior to the re-approximated posterior rectus sheath. Preperitoneal mesh extension is allowed via transversus abdominis release (TAR). The anterior rectus sheath is closed over the mesh, which closes the hernia.
A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar closure of the hernia defect and similar retromuscular mesh placement as for the open approach. Preperitoneal mesh extension is allowed via TAR. The da Vinci System is a robotic-assisted surgical device that allows the surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of the abdominal cavity. Rather than one long incision with open repair, four to six small incisions are made along the outer part of the abdomen between the rib cage and the hip.