The Robotic Versus Laparoscopic Ventral Hernia Repair study is an interventional trial recruiting patients undergoing elective ventral hernia repair appropriate for minimally invasive surgery.
The trial will compare outcomes of laparoscopic and robotic approaches to ventral hernia repair. compared with the laparoscopic approach, and has been endorsed by the American Hernia Society. However, this evidence is based on database and cohort studies, and more randomized, controlled trials are needed to assess the true effects of the robotic approach.
Patients will be included if they are scheduled for a ventral hernia repair that has been deemed appropriate for minimally invasive surgery. Exclusion criteria include being unlikely to survive for 2 years post surgery, being unlikely to follow up, having advanced chronic obstructive pulmonary disease or congestive heart failure, having a history of open abdomen or extensive lysis of adhesions, having ascites caused by cirrhosis or malignancy, having an active infection, and having a hernia defect size larger than 12 cm.
The primary outcome measure is total number of days spent in the hospital. Secondary outcomes include rates of surgical site infection, rates of surgical site occurrence, rates of hernia reoccurrence, patient-centered outcomes collected using HerQLes (a hernia quality of life measuring instrument), patient-centered outcomes collected using the EQ-5D questionnaire, and cost from a health care perspective.
The primary completion date is April 30, 2020, and the study completion date is April 30, 2023. About 120 people are expected to be recruited.
Find more information on the study page at Clinicaltrials.gov.