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

NCT ID: NCT03133533

Last Updated: 2018-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2023-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to receive either laparoscopic or robot-assisted repair of inguinal hernia.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic

laparoscopic inguinal hernia repair

Group Type ACTIVE_COMPARATOR

laparoscopic repair

Intervention Type PROCEDURE

Surgical inguinal hernia repair using laparoscopic approach.

robot-assisted

robot-assisted inguinal hernia repair

Group Type ACTIVE_COMPARATOR

robot-assisted repair

Intervention Type PROCEDURE

Surgical inguinal hernia repair using robot-assisted approach.

Interventions

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laparoscopic repair

Surgical inguinal hernia repair using laparoscopic approach.

Intervention Type PROCEDURE

robot-assisted repair

Surgical inguinal hernia repair using robot-assisted approach.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* surgeon determined need for inguinal hernia repair

Exclusion Criteria

* \< 18 years of age
* \> 99 years of age
* medical indication for open repair
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Latzko, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201601494

Identifier Type: -

Identifier Source: org_study_id

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