Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall heRnias (ROCSTAR)

Launched by ALGEMEEN ZIEKENHUIS MARIA MIDDELARES · Oct 8, 2022

Keywords

ClinConnect Summary

The ROCSTAR trial is studying the best way to treat large ventral incisional hernias, which are bulges in the abdominal wall that can occur after surgery. The trial compares two surgical methods: one that uses robotic technology and another that is done with traditional open surgery. Researchers want to find out if the robotic method can lead to shorter hospital stays and fewer complications for patients compared to the open surgery technique.

To participate in the trial, you need to be between the ages of 65 and 74 and have a large ventral incisional hernia that is more than 8 centimeters wide. However, certain individuals won’t be eligible, such as those who are pregnant, have certain serious health conditions, or have had specific prior surgeries. If you join the trial, you can expect to receive one of the two surgical treatments, and your progress will be monitored to help researchers gather important information about the effectiveness and safety of the robotic approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - All patients requiring treatment of a wide ventral incisional hernia (of more than 8 centimetres in width)
• Exclusion Criteria:
• • Pregnant or suspected pregnancy
• • Not-curatively treated malignancy, with life expectancy less than 24 months
• • Patients unable to give informed consent or complete study specific questionnaires
• • Emergency surgery
• • Primary ventral hernia repair
• • Exclusively lateral hernias not involving the midline
• • Incisional hernia repair after open abdomen or enterocutaneous fistula
• • Active wound infection
• • Previous anterior or posterior component separation
• • Patients with an existing ostomy
• • Patients with a life expectancy of less than 24 months
• • Patients suspected of being unable to comply with the study protocol