Incisional hernia.
Conditions
Interventions
Only surgeons, experienced in both open and laparoscopic incisional hernia repair, will participate in the INCH-trial. Patients are randomized for either open or laparoscopic incisional hernia repair.
Sponsors
Foreest Instituut Alkmaar: sponsoring obtained
ZonMW: in progress
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients, who are referred to the surgical clinic for assessment of an incisional hernia, either primary or recurrent. Imaging of the abdomen will only be done when it is unclear whether an incisional hernia is present. The need for surgery will be determined; pain, severe discomfort and episodes of visceral incarceration are indications for surgery. Only symptomatic patients will get a surgical correction of the incisional hernia. After consenting to the study, the patient will be randomized to either open or laparoscopic repair.
Exclusion criteria
Exclusion criteria: 1. Pregnancy; 2. Age under 18; 3. Abdominalostomy; 4. History of open abdomen treatment; 5. Mentally or cognitively unable to be consented; 6. A life expectancy of less than one year; 7. Immune-compromised patients; 8. ASA>3 (ASA: scoring system of the American Society of Anaesthesiologists).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is length of hospital stay after an incisional hernia repair. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, costs, recurrences, mortality and quality of life. | — |
Contacts
Public ContactM.M. Poelman
de Boelenlaan 1117
Outcome results
None listed