← Back to Search

Procedure

Laparoscopic robotic DaVinci assisted inguinal hernia repair for Port-site Injury

N/A
Waitlist Available
Led By Krzysztof Wikiel, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up biopsies will be taken right away and analysed within 1-2 weeks.
Awards & highlights

Summary

This trial will study if stray energy transfer during laparoscopic surgery is a cause of serious complications, and if so, how to reduce the risk of patient injury.

Eligible Conditions
  • Port-site Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~biopsies will be taken right away and analysed within 1-2 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and biopsies will be taken right away and analysed within 1-2 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Histologic analysis of port-site skin biopsies

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Laparoscopic robotic DaVinci assisted inguinal hernia repairExperimental Treatment1 Intervention
Intervention: 30 patients will undergo a robotic assisted laparoscopic inguinal hernia repair. This will be done using the DaVinci Robotic Platform by Intuitive Surgical. This an accepted safe method of repairing inguinal hernia. This platform uses special robotic ports produced and supplied by Intuitive Surgical required to dock the machine to the patient. Monopolar energy will be provided by a ForceTriad system (Covidien, Boulder, CO), standard an common system used in most ORs. This will be used for dissection. The investigators will obtain small biopsies from port site to assess stray energy transfer injury, a model described by earlier studies.
Group II: Standard Laparoscopic inguinal hernia repairActive Control1 Intervention
Intervention: 30 patients will undergo a laparoscopic inguinal hernia repair, an accepted safe method of repairing inguinal hernia. This platform uses standard laparoscopic ports. In our institution we use plastic ports made by Covidien, Boulder, CO. The operation will require two 5mm VersaPort (Covidien) and a Hassan Port. As in the robotic arm, monopolar energy will be provided by a ForceTriad system (Covidien, Boulder, CO), standard an common system used in most ORs. This will be used for dissection. The investigators will obtain small biopsies from port site to assess stray energy transfer injury, a model described by earlier studies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Laparoscopic robotic DaVinci assisted inguinal hernia repair
2019
N/A
~50

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,795 Previous Clinical Trials
2,796,828 Total Patients Enrolled
Krzysztof Wikiel, MDPrincipal InvestigatorECHCS/Denver VA
~6 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top