INCH-Trial.
- Conditions
- Incisional hernia.
- Registration Number
- NL-OMON25958
- Lead Sponsor
- Foreest Instituut Alkmaar: sponsoring obtainedZonMW: in progress
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 270
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.
1. Pregnancy;
2. Age under 18;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is length of hospital stay after an incisional hernia repair.
- Secondary Outcome Measures
Name Time Method Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, costs, recurrences, mortality and quality of life.