Cost- Effectiveness and Cost-utility of Laparoscopic Versus Open Repair of Ventral Hernia: Randomized Clinical Trial

Population: 130 patients, diagnosed with clinic and radiologic (abdominal wall CT scan) ventral hernia, were recruited, after expressing their willingness, for either laparoscopic or laparotomy repair to be conducted at Infanta Elena Hospital, Huelva (Spain), between January 2005 and October 2008. Recruitment criteria were: patients above 18 years old, diagnosed with primary or incisional ventral hernia, including recurrent ones, featuring a prior-to-operation estimated size from 20 to 225 cm2. Exclusion criteria included type 4 or 5 of ASA (American Society of Anesthesiologist), to suffer from a disease limiting lifespan to less than 2 years, cirrhotic ascites, emergency surgery or any complication as intestinal obstruction, strangulated hernia, peritonitis, local or systemic infection, failure of patient to ensure an at least 2 years follow-up or abandonment protocol. Every patient was fully informed and signed his willingness. Defect sizes were estimated and classified following Chevrel Classification. Patients were assigned a randomly generated number (see validated and published tables), meaning both laparoscopic or open repair, and informed same morning of operation. All operations were conducted by experienced surgeons. Protocol was approved by Local Ethics Committee.

General techniques

All patients were given an heparin prophylactic dose to prevent thromboembolic events evening prior to operation-day, as well as 1500 mg cefuroxime intravenous (IV) during anesthetic induction (in case of allergy, 600 mg of clindamycin IV + 80 mg of gentamicin IV). Also, evening before intervention-day all patients filled in survey (SF-36 questionnaire). Skin was prepared with an alcoholic solution of clorhexidine. Surgical pain was treated with magnesium metamizole (2gr IV each 6 hours). Upon patient request, 100 mg of tramadol IV was added (a maximum amount of 400 mg). Every patient was encouraged to hang around as soon as possible and be on a diet 8 hours after surgery, supplying oral treatment from then onwards. On discharge, patients were recommended wearing an abdominal binder for a month.

Laparoscopic repair: Pneumoperitoneum was performed to 12 mmHg after placement first 12 mm trocar at level of umbilicus in anterior axillary line. Subsequently are placed two 5 mm auxiliary trocars. In all cases we explore entire abdominal wall for other defects not detected preoperatively. 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. Not abdominal drainage was used. Skin was closed with metal staples. 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. In all cases we use 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. We used one or two suction drains below subcutaneous flap which was sutured with absorbable suture, and metallic skin staples.