Cost- Effectiveness and Cost-utility of Laparoscopic Versus Open Repair of Ventral Hernia
Hernia, Ventral
About this trial
This is an interventional health services research trial for Hernia, Ventral
Eligibility Criteria
Inclusion Criteria:
- Patients above 18 years old, diagnosed
- Primary or incisional ventral hernia (clinic and radiologic: abdominal wall CT scan), including recurrent ones,
- Hernia estimated size from 20 to 225 cm2.
Exclusion Criteria:
- Included type 4 or 5 of ASA (American Society of Anesthesiologist),
- Disease limiting lifespan to less than 2 years,
- Cirrhotic ascites,
- Emergency surgery
- intestinal obstruction,
- strangulated hernia,
- peritonitis,
- Local or systemic infection,
- failure of patient to ensure an at least 2 years follow-up or abandonment protocol.
Sites / Locations
- Hospital Infanta Elena
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Laparoscopic ventral hernia repair
Open ventral hernia repair
Laparoscopic repair: Pneumoperitoneum was performed to 12 mmHg. Herniary contents and sac are reduced releasing adhesions with diathermy or harmonic scalpel. Defects are repaired with a polytetrafluoroethylene (PTFE) patch (Dual Mesh; W.L Gore and Associates, FlagstaV, AZ USA) with double crown fixation as technique of Carbajo et al, ensuring exceed 3 cm edge of defect, using 5mm tackers (Protack, Autosuture; Tyco Healthcare, USA), reducing intrabdominal pressure to 8 mmHg. All operations were performed by experienced surgeons, over than 40 laparoscopic ventral hernia repairs.
Open repair: Incision was made over hernia defect, reducing herniary contents by opening sac if it is necessary. We made 4 cm soft tissue flaps around edge of defect depending on available healthy fascial tissue. Chevrel technique with fascial closure using anterior rectus sheath with continuous and absorbable suture and placement of polypropylene mesh (Parietene standart polypropylene mesh, Covidien, Norwalk, CT) in an onlay position fixed with polypropylene suture.