Laparoscopic Versus Robot-assisted Ventral Hernia Repair: a Single Institution Randomized Controlled Trial

Not Applicable

Withdrawn

• Conditions: Ventral Hernia
• Interventions: Procedure: laparoscopic repair; Procedure: robot-assisted repair

• Registration Number: NCT03133715
• Lead Sponsor: University of Florida

Brief Summary

Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery.

Detailed Description

Ventral 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 Timeline

• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Status Verified: 2018-06
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24
• Study Start: 2019-05-01
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• surgeon determined need for ventral hernia repair

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Exclusion Criteria

• <18 & >99 years of age
• Pregnant
• Medical indication for open repair

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic ventral hernia	laparoscopic repair	laparoscopic ventral hernia repair
robot-assisted ventral hernia	robot-assisted repair	robot-assisted ventral hernia repair

Primary Outcome Measures

Name	Time	Method
Operative time	perioperative time	time from start to finish of procedure, procedure start and stop times as recorded by anesthesia

Secondary Outcome Measures

Name	Time	Method
Post operative pain score	until year five post-operative	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, and one year postoperatively

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States