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

Not Applicable

Withdrawn

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

• Registration Number: NCT03133533
• Lead Sponsor: University of Florida

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Study Start: 2018-05
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-06-18
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

• surgeon determined need for inguinal hernia repair

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative pain score	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.

Trial Locations

Locations (1)

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