Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: A Single Institution Randomized Controlled Trial

June 14, 2018 updated by: University of Florida

Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial

Randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia repair.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Inguinal hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • surgeon determined need for inguinal hernia repair

Exclusion Criteria:

  • < 18 years of age
  • > 99 years of age
  • medical indication for open repair

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: laparoscopic
laparoscopic inguinal hernia repair
Procedure: laparoscopic repair
Surgical inguinal hernia repair using laparoscopic approach.
ACTIVE_COMPARATOR: robot-assisted
robot-assisted inguinal hernia repair
Procedure: robot-assisted repair
Surgical inguinal hernia repair using robot-assisted approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Immediate perioperative time
Time from start to finish of procedure, procedure start and stop times as recorded by anesthesia.
Immediate perioperative time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain score
Time Frame: Until 5 year postoperative
Abdominal pain at rest and on moving (recumbent to the upright position), will be assessed using 0-10 Numeric Pain Rating Scale preoperatively (baseline), and at 24 hours, 30 days, one and five years postoperatively.
Until 5 year postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: From immediately post-operative until year five following surgical inguinal hernia repair.
Postoperative 30 day complication rates will be recorded prospectively. All complications (including multiple occurrences per patient) will be recorded and graded per the Clavien-Dindo classification system.
From immediately post-operative until year five following surgical inguinal hernia repair.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (ACTUAL)

April 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201601494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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