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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01008709
Other study ID # 090917
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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