Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery

Laparoscopy Clinical Trial

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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01008709
• Other study ID #: 090917
• Status: Terminated
• Phase: N/A
• First received: October 30, 2009
• Last updated: April 17, 2017
• Start date: October 2009
• Est. completion date: November 2012

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: November 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopy
• Nephrectomy
• Prostatectomy
• Robotics

Intervention

Device:
• Teleflex HemoLock clip
Patients randomized to the Aesculap U-clip device or the HemoLock clip will undergo their respective surgery (robotic prostatectomy and laparoscopic and robotic renal surgery) as per standard protocols. During the surgical procedure, when primary vascular control is warranted the appropriate clip to which the patient has been randomized will be utilized. Immediate assessment of the vascular pedicle will subsequently occur; if hemostasis is not adequate, additional clipping, endomechanical stapling or suture ligation will then be performed as necessary.
• Aesculap U-clip
Patients randomized to the Aesculap U-clip device or the HemoLock clip will undergo their respective surgery (robotic prostatectomy and laparoscopic and robotic renal surgery) as per standard protocols. During the surgical procedure, when primary vascular control is warranted the appropriate clip to which the patient has been randomized will be utilized. Immediate assessment of the vascular pedicle will subsequently occur; if hemostasis is not adequate, additional clipping, endomechanical stapling or suture ligation will then be performed as necessary.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2007 Oct 24. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	significant difference in clip misfire and misapplication rates		1month
Secondary	blood loss / need for transfusion		1 month
Secondary	OR time		1 day
Secondary	Need for repeat procedure		1 month
Secondary	number of clips used		1 day
Secondary	surgeon impression of the ease of application		1 day
Secondary	predicted cost differential (or at least charge differential)		1 month