Clinical trial NCT01008709: Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery
Official title: Minimally Invasive Urologic Surgery Clip Evaluation: Can We Improve Our Surgical Technique, Reduce Costs and Waste With the Aesculap U-clip Versus the Tele-Flex Hemolock Clip?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostatectomy
Nephrectomy
Laparoscopy
Robotics
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Intracorporeal suturing and knot tying during robotic prostatectomy and laparoscopic and robotic renal surgery have historically been considered the most technically challenging and time consuming aspects of these procedures. With improved operative technique as well as the use of innovative surgical devices, vascular control during these surgeries is often less cumbersome as compared with traditional techniques. Current standard methods of hemostasis include the use of clips, of which the most popular design is the Hemolock, a locking, nonabsorbable plastic clip, or the use of the very expensive endomechanical stapler. Unfortunately while they are associated with time savings in the operating room, there is a great deal of disposable costs associated with these various devices as well as a not insignificant device malfunction rate reported in the literature. The aim of this case-controlled study is to evaluate the Aesculap U-clip device compared to our current technique of vascular control using the Teleflex Hemolock clip device during minimally invasive genitourinary surgery.


Eligibility criteria: Inclusion Criteria:

* All patients ≥ 18 years old with genitourinary malignancy either prostate cancer or kidney renal masses undergoing minimally invasive genitourinary organ removal will be included in this small pilot study.

Primary outcomes:
measure: significant difference in clip misfire and misapplication rates
timeFrame: 1month
Secondary outcomes:
measure: blood loss / need for transfusion
timeFrame: 1 month
measure: OR time
timeFrame: 1 day
measure: Need for repeat procedure
timeFrame: 1 month
measure: number of clips used
timeFrame: 1 day
measure: surgeon impression of the ease of application
timeFrame: 1 day
measure: predicted cost differential (or at least charge differential)
timeFrame: 1 month
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Department of Urologic Surgery
name: S. Duke Herrell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meng MV. Reported failures of the polymer self-locking (Hem-o-lok) clip: review of data from the Food and Drug Administration. J Endourol. 2006 Dec;20(12):1054-7. doi: 10.1089/end.2006.20.1054.
citation: Hsi RS, Saint-Elie DT, Zimmerman GJ, Baldwin DD. Mechanisms of hemostatic failure during laparoscopic nephrectomy: review of Food and Drug Administration database. Urology. 2007 Nov;70(5):888-92. doi: 10.1016/j.urology.2007.06.1116. Epub 2007 Oct 24.