FROM CLINICALTRIALS.GOV
The Role of the Robotic Platform in Inguinal Hernia Repair Surgery is an interventional trial currently recruiting patients who require inguinal hernia repair surgery.
The trial will compare postoperative pain in patients undergoing laparoscopic inguinal hernia surgery repair or robotic inguinal hernia repair surgery. The laparoscopic approach has been used frequently and has several advantages. However, it has several disadvantages that the robotic approach may address. As such, the study investigators have hypothesized that the robotic approach will result in less postoperative pain than the laparoscopic approach.
Inclusion criteria for the study include having had no prior open abdominal surgery at or below the umbilicus or preperitoneal mesh placement, presenting for primary or recurrent unilateral inguinal hernia repair, being at least 21 years old, and having a body mass index less than or equal to 40 kg/m2. Patients will be excluded if they have a need for open inguinal hernia repair, present for evaluation of bilateral inguinal hernias, require surgical repair of a strangulated inguinal hernia, have liver disease or end-stage renal disease, or cannot give informed consent.
The primary outcome measure is the difference in postoperative pain between patients who undergo robotic inguinal hernia repair and those who undergo laparoscopic inguinal hernia repair during the 2 years following surgery. Secondary outcome measures include differences in surgeon ergonomics between the two approaches, institution cost analysis, and long-term recurrence rate differences, all within 2 years of surgery.
The study will end in May 2019. About 100 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov .
SOURCE: Clinicaltrials.gov. NCT02816658.
