INCH-trial: A multicenter randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional-hernia repair.

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.

STUDY DESIGN: A randomized multi-center clinical trial comparing
cost-effectiveness of open and laparoscopic repair of incisional hernias.

STUDY POPULATION: Patients with a symptomatic incisional hernia, eligible for
laparoscopic and open incisional hernia repair.

INTERVENTION: 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.

OUTCOME MEASURES: 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 and quality 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. Because of an expected loss to follow-up, 300 patientes will be
included.

ECONOMIC EVALUATION: 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.

TIME SCHEDULE: For the INCH trial 2 months of study preparation are needed.
Next, 28 months are needed for accrual of a total of 300 patients (150 per
arm). This period is followed by 3 months of follow-up and 3 months of data
analysis and reporting.

The main goal of the trial is to establish whether laparoscopic incisional
hernia repair is superior to conventional open incisional hernia repair in
terms of cost-effectiveness. This is measured through length of hospital stay
and quality of life. Secondary endpoints are re-operation-rate (due to
complications or recurrence), morbidity, mortality and shape of the abdomen.

Patients who fit the inclusion criteria and have an incisional hernia will be
randomized using a computer generated randomization list which can be accessed
electronically. Stratification will be by centre and by primary or recurrent
incisional hernia. This trial is based on a superiority principle.

Patients will either undergo laparoscopic or open incisional hernia repair.
There two groups will be compared.

Apart for the normal surgical risks, no extra risks comes with consenting to
this trial. The extra burdens are completing a diary for a few weeks, and some
questionnaires when visiting the out-patient clinics.