A randomized clinical trial will compare two techniques for achieving extraperitoneal space during hernia surgery.
The Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair trial aims to determine whether these techniques are comparable in operative times, early postoperative pain scores, surgical complications, and rate of hernia recurrence. The Spacemaker Balloon Dissector will be used for the trial .
To be included in the trial, patients must be over age 18; be scheduled to undergo unilateral, elective inguinal hernia repair; and consent to the use of surgical mesh for their surgery. Among the exclusion criteria are patients undergoing bilateral inguinal hernia or emergent inguinal hernia repairs (acute incarceration or strangulation) or undergoing operations for recurrent inguinal hernia with prior preperitoneal mesh.
The techniques will be timed and measured in minutes from incision to end of procedure. Pain outcomes will be measured using the Numeric Pain Rating Scale (NRS-11) at postoperative days 1, 7, and 30. Intraoperative complications, 30-day infections, and 1-year recurrence will be reported in numbers and percent as appropriate.
The study is sponsored by The Cleveland Clinic.
For more details about the trial, go to www.clinicaltrials.gov .
SOURCE: Clinical Trial NCT03276871.