Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery - Full Text View

Purpose

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.

Condition	Intervention
Prostatectomy Nephrectomy Laparoscopy Robotics	Device: Teleflex HemoLock clip Device: Aesculap U-clip

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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?

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

significant difference in clip misfire and misapplication rates [ Time Frame: 1month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

blood loss / need for transfusion [ Time Frame: 1 month ] [ Designated as safety issue: No ]
OR time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Need for repeat procedure [ Time Frame: 1 month ] [ Designated as safety issue: No ]
number of clips used [ Time Frame: 1 day ] [ Designated as safety issue: No ]
surgeon impression of the ease of application [ Time Frame: 1 day ] [ Designated as safety issue: No ]
predicted cost differential (or at least charge differential) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 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	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.
Active Comparator: 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.	Device: 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.

Arms

Assigned Interventions

Placebo Comparator: 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

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.

Active Comparator: 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.

Device: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008709

Contacts

Contact: S. Duke Herrell, MD

(615) 343-1317

duke.herrell@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37212

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

S. Duke Herrell, MD

Vanderbilt University Department of Urologic Surgery

More Information

Publications:

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.

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.

Responsible Party:	Stanley Duke Herrell, M.D., Vanderbilt University Department of Urologic Surgery
ClinicalTrials.gov Identifier:	NCT01008709 History of Changes
Other Study ID Numbers:	090917
Study First Received:	October 30, 2009
Last Updated:	October 18, 2010
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013