INTRODUCTION: The optimal repair of inguinal hernias remains controversial. It is recommended that an inguinal hernia be repaired using a mesh, either with a laparoscopic or an open approach. In Denmark, the laparoscopic approach is used in an increasing number of cases. The laparoscopic repair has a learning curve of about 50-100 cases and decreases chronic pain, but slightly increases the risk of serious complications compared with open mesh repairs. Therefore, a simpler kind of operation is needed. The ONSTEP technique is a possible solution to this problem. The objective of the present randomised clinical trial described in this protocol is to evaluate chronic pain after inguinal hernia repair using the ONSTEP method versus the laparoscopic approach. METHODS: This study is designed as a non-inferiority, two-arm, multicentre, randomised clinical trial, with a 1:1 allocation to ONSTEP or laparoscopic repair. Patients are recruited from surgical departments in Denmark and follow-up is one year. In total, 188 patients will be included. DISCUSSION: This protocol describes one of the first randomised clinical trials investigating the ONSTEP technique. To our knowledge, it is the first clinical trial comparing the ONSTEP technique with the laparoscopic technique. The results from this study are needed before it can be decided whether the ONSTEP technique should replace the laparoscopic technique in general surgical practice. FUNDING: This study has not received external funding. TRIAL REGISTRATION: NCT01960777 (clinicaltrials.gov).
RCT Entities:
INTRODUCTION: The optimal repair of inguinal hernias remains controversial. It is recommended that an inguinal hernia be repaired using a mesh, either with a laparoscopic or an open approach. In Denmark, the laparoscopic approach is used in an increasing number of cases. The laparoscopic repair has a learning curve of about 50-100 cases and decreases chronic pain, but slightly increases the risk of serious complications compared with open mesh repairs. Therefore, a simpler kind of operation is needed. The ONSTEP technique is a possible solution to this problem. The objective of the present randomised clinical trial described in this protocol is to evaluate chronic pain after inguinal hernia repair using the ONSTEP method versus the laparoscopic approach. METHODS: This study is designed as a non-inferiority, two-arm, multicentre, randomised clinical trial, with a 1:1 allocation to ONSTEP or laparoscopic repair. Patients are recruited from surgical departments in Denmark and follow-up is one year. In total, 188 patients will be included. DISCUSSION: This protocol describes one of the first randomised clinical trials investigating the ONSTEP technique. To our knowledge, it is the first clinical trial comparing the ONSTEP technique with the laparoscopic technique. The results from this study are needed before it can be decided whether the ONSTEP technique should replace the laparoscopic technique in general surgical practice. FUNDING: This study has not received external funding. TRIAL REGISTRATION: NCT01960777 (clinicaltrials.gov).