Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery

NCT01008709 | Terminated FDA Device

• 1 other identifier: 090917
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatectomy; Nephrectomy; Laparoscopy; Robotics

Outcome Measures

Primary Outcomes (1)

• significant difference in clip misfire and misapplication rates

  1month

Secondary Outcomes (6)

• blood loss / need for transfusion

  1 month

• OR time

  1 day

• Need for repeat procedure

  1 month

• number of clips used

  1 day

• surgeon impression of the ease of application

  1 day

Study Arms (2)

Teleflex HemoLock clip

PLACEBO COMPARATOR

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

Aesculap U-Clip

ACTIVE COMPARATOR

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

Interventions

Teleflex HemoLock clip DEVICE

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.

Teleflex HemoLock clip

Aesculap U-clip DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (2)

• 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.

  PMID: 17206901 BACKGROUND

• 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.

  PMID: 17919695 BACKGROUND

Study Officials

• S. Duke Herrell, MD

  Vanderbilt University Department of Urologic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 6, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2012
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)