The Role of the Robotic Platform in Inguinal Hernia Repair Surgery
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|ClinicalTrials.gov Identifier: NCT02816658|
Recruitment Status : Active, not recruiting
First Posted : June 28, 2016
Last Update Posted : June 18, 2019
Inguinal hernia repair is one of the most commonly performed general surgery operations. However, to date, the ideal surgical approach for inguinal hernia surgery. The investigators therefore, propose a randomized controlled trial comparing laparoscopic inguinal hernia surgery repair to robotic inguinal hernia repair surgery.
The investigators hypothesize that the robotic approach to inguinal hernia repair will result in improved post-operative outcomes compared to traditional laparoscopic inguinal hernia repairs.
Specific Aim #1: To determine if the robotic approach will result in a significant reduction in postoperative pain and earlier return to full function when compared to a laparoscopic inguinal hernia repair.
Specific Aim #2: To perform a cost analysis to determine the financial implications of performing a robotic versus a laparoscopic inguinal hernia repair.
Specific Aim #3: To determine the effect of surgeon reported ergonomics when performing laparoscopic versus robotic inguinal hernia repairs.
Specific Aim #4: Evaluate the long term hernia recurrence rates associated with laparoscopic versus robotic inguinal hernia repairs.
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Inguinal||Other: Laparoscopic Inguinal Hernia Repair Other: Robotic Inguinal Hernia Repair||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Role of the Robotic Platform in Inguinal Hernia Repair Surgery|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Active Comparator: Laparoscopic Surgery
Laparoscopic Inguinal Hernia Repair through a Transabdominal, Preperitoneal Approach
Other: Laparoscopic Inguinal Hernia Repair
Laparoscopic Inguinal Hernia Repair
Active Comparator: Robotic Surgery
Robotic Inguinal Hernia Repair
Other: Robotic Inguinal Hernia Repair
Robotic Inguinal Hernia Repair
- Pain Score [ Time Frame: 2 Years ]Differences in postoperative pain between those patients who undergo robotic inguinal hernia repair versus laparoscopic inguinal hernia repair.
- Ergonomic Tool [ Time Frame: 2 Years ]Differences in surgeon ergonomics between the two approaches as measured by the NASA-TLX and RULA ergonomic assessments.
- Institution cost analysis [ Time Frame: 2 Years ]Total cost of the operation for the two approaches.
- Long-term recurrence rate differences [ Time Frame: 2 Years ]Comparison of recurrence rates, as assessed by an independed, blinded assessor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816658
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Mount Sinai Hospital|
|New York, New York, United States, 10028|
|United States, North Carolina|
|New Hanover Regional Medical Center|
|Wilmington, North Carolina, United States, 28401|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, South Carolina|
|Greenville Health System|
|Greenville, South Carolina, United States, 29681|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Michael J Rosen, MD||The Cleveland Clinic|