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EnSeal Efficacy and Bursting Pressure in Human Vessels

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by University of Illinois at Chicago.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01312246
First Posted: March 10, 2011
Last Update Posted: March 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ethicon Endo-Surgery
Information provided by:
University of Illinois at Chicago
  Purpose

In this study the investigators will include adult patients who are not part of a vulnerable patient population. Inclusion criteria include patients who will be undergoing resection of part of their colon that will require dividing the IMA. The investigators will use the resected surgical specimens for our project. The investigators will use the EnSeal on all major vessels in our procedure. The investigators will use the EnSeal 5 mm round head model. Due to the nature of the project, we will apply for IRB approval prior to beginning our research. The investigators plan to include 60 total patients in the study, 30 at the University of Illinois and 30 at Lutheran General Hospital.

Prior to resection, the investigators will use a sterile caliper to take an in-vivo measurement of the IMA and IMV. Immediately after resection, the investigators will remove the sealed proximal end of the IMA and the 3 cm distal to it from the surgical specimen. The investigators will similarly prepare the IMV. The investigators will inspect our vessels for any iatrogenic traumatic tears. If the vessels are suitable, the investigators will then gentle apply manual traction to remove any blood or clots within the lumen. The investigators will measure the outer diameter of the vessels using a digital caliper. If there are small branches, the investigators will tie them off with suture. The unsealed end will then be attached to the burst pressure tester with suture and it will be tested for the bursting pressure. The device measures pressure continuously as it infuses the segment with normal saline at a steady rate (50 ml/hr). A leak will be determined by a decrease in intra-luminal pressure of 100 mm Hg or a visible leak. A failure to seal the vessels will be determined by a bursting pressure of less than 100 mm Hg. It should be noted that each section would only be pressure-tested once. All of our data will be collected on the enclosed data sheet we have created for use in this protocol. The investigators will then place the vessels with the original surgical specimen where it will be submitted for routine pathological examination of surgical specimens. Twenty five specimens at each site will undergo the testing, whereas 5 specimens will be sent to pathology without testing.

Our pathologist will analyze the submitted specimen for extent of seal, disruption of vessel smooth muscle, gas bubbles, and will stain for elastin to analyze the disruption in the vessel wall. In addition, the seal will be measured and we will obtain digital images. The specimens submitted for pathology will be 5 burst specimens as well as 5 un-burst specimens taken from the pool of 25 patients at UIC.

For our human component, the investigators have estimated the standard deviation and width of the confidence interval to be 100 mm Hg each. With a 95% confidence level, the investigators expect to require 16 measurements for human specimens from 16 patients although the investigators will use 50 patients to allow for errors in obtaining pressures.

Our timeline for the completion of the projects is 6 months. The investigators plan on being able to complete the human burst pressure testing within 6 months.


Condition Intervention
Colon and Rectal Diseases Device: EnSeal Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: EnSeal Efficacy and Bursting Pressure in Human Vessels

Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • EnSeal Efficacy and Bursting Pressures in Human Vessels [ Time Frame: 21 months ]
    Demonstrate that the bursting pressures in large vessels (IMA, IMV) sealed in colectomy of human patients are sufficiently high. Using the EnSeal device on larger vessels, the investigators believe, would further reduce operating time, blood loss, and hasten post-operative recovery from less tissue manipulation.


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: EnSeal Device
    measurement of bursting pressure of colonic vessels after using the EnSeal Device
    Other Name: EnSeal Device- Ethicon Endo Surgery
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Include patients who will be undergoing resection of part of their colon that will require dividing the colonic vessels. The use of the resected surgical specimens is included our project.

Exclusion Criteria:

  • Patients who do not meet the the inclusion criteria.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312246


Contacts
Contact: Saeed s Albalawi, MD 3129619364 saeed_aradi@hotmail.com
Contact: Nathalie Mantilla, MD 312-996-5162 farfanmn@uic.edu

Locations
United States, Illinois
University Of Illinois Medical Center at Chicago Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Saeed S Abalawi, MD    312-961-9364    saeed_aradi@hotmail.com   
Contact: Nathalie Mantilla, MD    312-996-5162    farfanmn@uic.edu   
Sub-Investigator: SAEED S ALBALAWI, MD         
Principal Investigator: Leela M Prasad, MD         
Sub-Investigator: Marek Zawadzki, MD         
Sub-Investigator: VAMSI R VELCHURU, MD,FRCS         
Sub-Investigator: NATHALIE MANTILLA, MD         
Sub-Investigator: ARIANE ABCARIAN, MD         
Sponsors and Collaborators
University of Illinois at Chicago
Ethicon Endo-Surgery
Investigators
Principal Investigator: Leela M Prasad, MD University of Illinois at Chicago
  More Information

Publications:
Newcomb WL, Hope WW, Schmelzer TM, Heath JJ, Norton HJ, Lincourt AE, Heniford BT, Iannitti DA. Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices. Surg Endosc. 2009 Jan;23(1):90-6. doi: 10.1007/s00464-008-9932-x. Epub 2008 May 16.
Person B, Vivas DA, Ruiz D, Talcott M, Coad JE, Wexner SD. Comparison of four energy-based vascular sealing and cutting instruments: A porcine model. Surg Endosc. 2008 Feb;22(2):534-8. Epub 2007 Dec 20.
Campagnacci R, de Sanctis A, Baldarelli M, Rimini M, Lezoche G, Guerrieri M. Electrothermal bipolar vessel sealing device vs. ultrasonic coagulating shears in laparoscopic colectomies: a comparative study. Surg Endosc. 2007 Sep;21(9):1526-31. Epub 2007 Feb 8.
Entezari K, Hoffmann P, Goris M, Peltier A, Van Velthoven R. A review of currently available vessel sealing systems. Minim Invasive Ther Allied Technol. 2007;16(1):52-7. Review.
Gilleran JP, Thaly RK, Chernoff AM. Rapid communication: bipolar PlasmaKinetic transurethral resection of the prostate: reliable training vehicle for today's urology residents. J Endourol. 2006 Sep;20(9):683-7.
Meehan JJ. The robotic Gyrus PK: a new articulating thermal sealing device and a preliminary series report. J Laparoendosc Adv Surg Tech A. 2008 Feb;18(1):183-5. doi: 10.1089/lap.2007.0179.
Kang SK, Kunanandam T, Clark L. Prospective, case-control study of surgical efficiency of ultrasonic shear ('harmonic scalpel') thyroidectomy compared with conventional thyroidectomy. J Laryngol Otol. 2008 Nov;122(11):1194-6. doi: 10.1017/S0022215107001661. Epub 2008 Feb 19.
Lachanas VA, Hajiioannou JK, Karatzias GT, Filios D, Koutsias S, Mourgelas C. Comparison of LigaSure vessel sealing system, harmonic scalpel, and cold knife tonsillectomy. Otolaryngol Head Neck Surg. 2007 Sep;137(3):385-9.
Hagen B, Eriksson N, Sundset M. Randomised controlled trial of LigaSure versus conventional suture ligature for abdominal hysterectomy. BJOG. 2005 Jul;112(7):968-70.
Hefni MA, Bhaumik J, El-Toukhy T, Kho P, Wong I, Abdel-Razik T, Davies AE. Safety and efficacy of using the LigaSure vessel sealing system for securing the pedicles in vaginal hysterectomy: randomised controlled trial. BJOG. 2005 Mar;112(3):329-33.
Kaplan B, Wang Z, Keilani T, Kaufman DB. The specificity of monoclonal fluorescence polarization immunoassay for cyclosporine in recipients of simultaneous pancreas-kidney transplants. Ther Drug Monit. 1995 Oct;17(5):499-503.
Kössi J, Luostarinen M, Kontula I, Laato M. Laparoscopic sigmoid and rectal resection using an electrothermal bipolar vessel sealing device. J Laparoendosc Adv Surg Tech A. 2007 Dec;17(6):719-22.
Sahin DA, Kusaslan R, Sahin O, Akbulut G, Bas O, Dilek ON. Histopathological effects of bipolar vessel sealing devices on liver parenchyma and comparison with suture method: an experimental study. Eur Surg Res. 2007;39(2):111-7. Epub 2007 Feb 13.
Ching SS, Verbeke CS, Homer-Vanniasinkam S, McMahon MJ. Comparison of torsional and linear mode ultrasonic coagulating shears for sealing veins. J Laparoendosc Adv Surg Tech A. 2008 Dec;18(6):819-24. doi: 10.1089/lap.2008.0066.
Yekeler E, Danalioglu A, Movasseghi B, Yilmaz S, Karaca C, Kaymakoglu S, Acunas B. Crohn disease activity evaluated by Doppler ultrasonography of the superior mesenteric artery and the affected small-bowel segments. J Ultrasound Med. 2005 Jan;24(1):59-65.
Shatapathy P, Aggarwal BK, Punnen J. Inferior mesenteric artery as a free arterial conduit for myocardial revascularization. J Thorac Cardiovasc Surg. 1997 Jan;113(1):210-1.
van Andel CJ, Pistecky PV, Borst C. Mechanical properties of porcine and human arteries: implications for coronary anastomotic connectors. Ann Thorac Surg. 2003 Jul;76(1):58-64; discussion 64-5.

Responsible Party: Prasad Leela, university of Illinois
ClinicalTrials.gov Identifier: NCT01312246     History of Changes
Other Study ID Numbers: 2010-0878
First Submitted: March 9, 2011
First Posted: March 10, 2011
Last Update Posted: March 10, 2011
Last Verified: January 2011

Keywords provided by University of Illinois at Chicago:
vessel ligation
colon resection

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs


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