Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery

This study is currently recruiting participants.

Verified by University Hospitals of Cleveland, October 2008

Sponsors and Collaborators:	University Hospitals of Cleveland Tyco Healthcare Group
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00487409

Purpose

The purpose of this research is to compare two different standard of care surgical methods for the following large bowel (colon) procedures: laparoscopic right colectomy, total colectomy, and left colectomy. The study will compare electrocautery, used with surgical clips and/or surgical staplers, and the Ligasure vessel sealer. The investigators will be looking at which procedure is faster and more cost efficient and the investigators will calculate hospital expenses for the two groups to make comparisons.

Condition	Intervention
Colonic Diseases Rectal Diseases	Procedure: Bipolar electrosurgical generator and instruments Procedure: Disposable stapling instruments

MedlinePlus related topics: Colonic Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Trial Comparing Outcomes for the LigaSure and Disposable Stapling Instruments for Laparoscopic Surgery

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

Safety and efficacy of Ligasure device vs safety and efficacy of vascular staples or disposable clips [ Time Frame: 6 weeks post-op ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	December 2006
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A Standard of Care	Procedure: Disposable stapling instruments laparoscopic colectomy using clips, cautery and stapler
Group B Standard of Care	Procedure: Bipolar electrosurgical generator and instruments laparoscopic colectomy using the Ligasure device

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who have benign or malignant colonic or rectal disease that mandate resection and are approached laparoscopically. Potential indications or conditions include ulcerative colitis, Crohn's disease, colorectal polyps, colorectal malignancy, endometriosis, diverticulitis, and colonic inertia
Subjects who are 18 years of age and older
Subjects of either sex
Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent

Exclusion Criteria:

Subjects who undergo conversion to the open approach before mobilization of the colon or pedicle ligation will be excluded from the analysis
Subjects who are pregnant
Subjects who have undergone a previous colectomy
Subjects with a medical condition that may interfere with the evaluation of safety or effectiveness of the study device
Subjects who have another condition that in the opinion of the investigator precludes further participation in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487409

Contacts

Contact: Michelle Briehl, RN, BSN	216-844-4706	michelle.briehl@uhhospitals.org
Contact: Bridget Ermlich, RN, BSN	216-844-3602	bridget.ermlich@uhhospitals.org

Locations

United States, Ohio
University Hospitals of Cleveland Case Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Sub-Investigator: Bradley Champagne, MD
Sub-Investigator: Harry Reynolds, MD
Sub-Investigator: Vince Obias, MD

Sponsors and Collaborators

University Hospitals of Cleveland

Tyco Healthcare Group

Investigators

Principal Investigator:

Conor P. Delaney, MD, PhD

University Hospitals of Cleveland/ Institute for Surgical Innovation

More Information

Responsible Party:	University Hospitals of Cleveland ( Conor Delaney, MD, PhD )
Study ID Numbers:	10-06-33
Study First Received:	June 15, 2007
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00487409
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

Ulcerative colitis
Crohn's disease
Colorectal polyps
Colorectal malignancy

Endometriosis
Diverticulitis
Colonic inertia

Study placed in the following topic categories:

Diverticulitis
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Crohn Disease

Polyps
Endometriosis
Colitis, Ulcerative
Intestinal Diseases
Rectal Diseases
Colitis

ClinicalTrials.gov processed this record on January 16, 2009