|- candidate number||9238|
|- NTR Number||NTR2808|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-mrt-2011|
|- Secondary IDs||80-82310-97-12117 ZonMw|
|- Public Title||INCH-Trial.|
|- Scientific Title||The INCH-Trial: A multicentre randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional-hernia repair.|
|- hypothesis||Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair.|
|- Healt Condition(s) or Problem(s) studied||Incisional hernia|
|- 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||1. Pregnancy;|
2. Age under 18;
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).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2011|
|- planned closingdate||31-dec-2013|
|- Target number of participants||270|
|- 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. In both surgical techniques, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm.|
|- Primary outcome||Primary endpoint is length of hospital stay after an incisional hernia repair.|
|- Secondary outcome||Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, costs, recurrences, mortality and quality of life.|
|- Timepoints||28 months are needed for accrual of a total of 270 patients (135 per arm). This is followed by 3 months follow-up period to meet the primary end-point. To meet the secondary end-points the follow-up is continued at 1, 3 and five years after index surgery.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| M.M. Poelman|
|- CONTACT for SCIENTIFIC QUERIES|| M.M. Poelman|
|- Sponsor/Initiator ||Foreest Institute Alkmaar|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Foreest Institute Alkmaar|
|- Brief summary||OBJECTIVE: |
Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. About 15,000 of these
patients will develop an incisional hernia. Both open and laparoscopic surgical repair have been proven to be safe. However, the most effective treatment of incisional hernias remains unclear. This study, the 'INCH-trial', comparing cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed.
A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias.
Patients with a symptomatic incisional hernia, eligible for laparoscopic and open incisional hernia repair.
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. In both surgical techniques, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm.
Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints are
time to full recovery within three months after index surgery, post-operative complications, costs, recurrences, mortality andquality of life.
SAMPLE SIZE CALCULATION/ DATA ANALYSIS:
Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair. A difference of 2< days is considered significant. One-hunderd-and-thirty-five patients are needed in each treatment arm.
The economic evaluation will be performed from a societal perspective. Primary outcomes are costs per patient related to time-to-recovery and quality of life.
Two-hundred-seventy patients are needed (135 per arm). A follow-up period of 3 months is needed to meet the primary end-point. Follow-up will continue to meet the secondary end-points.
|- Main changes (audit trail)|
|- RECORD||14-mrt-2011 - 30-aug-2011|