Marijn Poelman

Repair of abdominal wall hernias with mesh is one of the most common procedures in general surgery. The introduction of hernia repair with mesh has lowered recurrence rates and shifted the focus to quality of life after surgery, raising the need for a specific tool measuring quality of life. The Carolinas Comfort Scale (CCS) is a questionnaire designed specifically for patients having hernia repair with mesh. The aim of this study is to validate the Dutch CCS and to compare it to the generic short form-36 (SF-36). The CCS questionnaire was translated into Dutch. Patients undergoing mesh hernia repair between April 2010 and December 2011 completed the CCS, the SF-36 and four questions comparing these two questionnaires in the first week after surgery. After 3 weeks, the CCS was repeated. Correlations between the two surveys were calculated using the Spearman’s rank correlation test with a 95 % confidence interval to determine validity. The response rate was 60.3 % (100/168). The CCS showed excellent reliability with a Cronbach’s α of 0.948. Significant correlation existed between the CCS and the domains physical functioning, bodily pain, role-physical, vitality and social functioning of the SF-36. Seventy-nine percent of the patients preferred the CCS to the SF-36, and 83 % considered the CCS a better reflection of their quality of life after hernia repair with mesh. The Dutch CCS appears a valid and clinically relevant tool for assessing quality of life after repair of abdominal wall hernia with mesh.

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. During incisional hernia repair, 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, recurrences, mortality and quality of life. Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair. A difference of two days is considered significant. One-hunderd-and-thirty-five patients are enrolled 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. 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 post-operative complications or recurrences, mortality and quality of life. The difference in time to full recovery between the two treatment strategies is thought to be in favor of laparoscopic incisional hernia repair. Laparoscopic incisional hernia repair is therefore expected to be a more cost-effective approach. Netherlands Trial register: NTR2808