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Trial record 3 of 5 for:    robotic laparoscopic | hernia | United States

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
Sponsor:
Information provided by (Responsible Party):
Michael Rosen, The Cleveland Clinic

Brief 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.


Condition or disease Intervention/treatment Phase
Hernia, Inguinal Other: Laparoscopic Inguinal Hernia Repair Other: Robotic Inguinal Hernia Repair Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Pain Score [ Time Frame: 2 Years ]
    Differences in postoperative pain between those patients who undergo robotic inguinal hernia repair versus laparoscopic inguinal hernia repair.


Secondary Outcome Measures :
  1. Ergonomic Tool [ Time Frame: 2 Years ]
    Differences in surgeon ergonomics between the two approaches as measured by the NASA-TLX and RULA ergonomic assessments.

  2. Institution cost analysis [ Time Frame: 2 Years ]
    Total cost of the operation for the two approaches.

  3. Long-term recurrence rate differences [ Time Frame: 2 Years ]
    Comparison of recurrence rates, as assessed by an independed, blinded assessor



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 21 years or older
  2. No prior open abdominal surgery at or below the umbilicus
  3. Primary or recurrent unilateral inguinal hernia repair
  4. No previous preperitoneal mesh placement
  5. BMI less than or equal to 40kg/m2

Exclusion Criteria:

  1. Need for an open inguinal hernia repair
  2. Patients presenting for evaluation of bilateral inguinal hernias
  3. Patients requiring surgical repair of a strangulated inguinal hernia
  4. Patients with liver disease defined by the presence of ascites
  5. Patients with end-stage renal disease requiring dialysis
  6. Patients who are unable to give informed consent.

Information from the National Library of Medicine

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


Locations
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United States, Missouri
Washington University
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
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Michael J Rosen, MD The Cleveland Clinic

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Responsible Party: Michael Rosen, Director, Cleveland Clinic Comprehensive Hernia Center, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02816658     History of Changes
Other Study ID Numbers: 15-1594
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal