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

University of Florida

Status: Withdrawn

Conditions: Ventral Hernia

Treatments: Procedure: robot-assisted repair; Procedure: laparoscopic repair

Study type: Interventional

Funder types: Other

Identifiers

NCT03133715

IRB201601533

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• surgeon determined need for ventral hernia repair

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

laparoscopic ventral hernia

Active Comparator group

Description:

laparoscopic ventral hernia repair

Treatment:

Procedure: laparoscopic repair

robot-assisted ventral hernia

Active Comparator group

Description:

robot-assisted ventral hernia repair

Treatment:

Procedure: robot-assisted repair