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The Role of the Robotic Platform in Inguinal Hernia Repair Surgery

NCT02816658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2022-02-01

No results posted yet for this study

Summary

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.

Conditions

  • Hernia, Inguinal

Interventions

OTHER

Laparoscopic Inguinal Hernia Repair

Laparoscopic Inguinal Hernia Repair

OTHER

Robotic Inguinal Hernia Repair

Robotic Inguinal Hernia Repair

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Michael J Rosen, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02816658 on ClinicalTrials.gov