NCT03133533

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

4.6 years

First QC Date

April 25, 2017

Last Update Submit

June 14, 2018

Conditions

Hernia, Inguinal

Keywords

robot-assisted

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Time from start to finish of procedure, procedure start and stop times as recorded by anesthesia.

    Immediate perioperative time

Secondary Outcomes (1)

  • Postoperative pain score

    Until 5 year postoperative

Other Outcomes (1)

  • Complications

    From immediately post-operative until year five following surgical inguinal hernia repair.

Study Arms (2)

laparoscopic

ACTIVE COMPARATOR

laparoscopic inguinal hernia repair

Procedure: laparoscopic repair

robot-assisted

ACTIVE COMPARATOR

robot-assisted inguinal hernia repair

Procedure: robot-assisted repair

Interventions

laparoscopic repairPROCEDURE

Surgical inguinal hernia repair using laparoscopic approach.

laparoscopic
robot-assisted repairPROCEDURE

Surgical inguinal hernia repair using robot-assisted approach.

robot-assisted

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgeon determined need for inguinal hernia repair

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Latzko, MD

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to receive either laparoscopic or robot-assisted repair of inguinal hernia.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2017

First Posted

April 28, 2017

Study Start

May 1, 2018

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

June 18, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)