INCH-trial: A multicenter randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional-hernia repair.
Phase 4
Completed
- Conditions
- ventral hernia/ incisional hernia10040795
- Registration Number
- NL-OMON41404
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria
Patients who:
- have an incisional hernia
- the need/wish for surgical repair
- laparoscopic repair is feasible
gave informed consent
Exclusion Criteria
Patients who:
- Are pregnant
- Have an ostomy
- Are younger than 18 years old
have an open abdomen treatment in the medical history.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcomes are:<br /><br>-Length of hospital stay<br /><br>-Quality of life measures through SF-36 and CCS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are:<br /><br>- Time to full recovery within a three months period.<br /><br>-Re-operation rate for recurrence or complications of the incisional hernia<br /><br>repair. The analysis will be continued after the cost-effectiveness study has<br /><br>ended, a longer follow-up is needed to examine the recurrence-rate.<br /><br>-28 days post surgery morbidity and mortality,<br /><br>-Shape of the abdomen: a digital photograph of the abdomen using<br /><br>raster-stereography will be taken pre- and post-operatively to analyse the<br /><br>change in the abdominal shape.<br /><br>-Total mean costs will be related to the following effect measures in the<br /><br>cost-effectiveness analyses:<br /><br>1) Time to full recovery<br /><br>2) Quality-adjusted life-years (QALYs) based on the SF-36.</p><br>