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Sponsors and Collaborators: |
University Hospitals of Cleveland Tyco Healthcare Group |
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Information provided by: | University Hospitals of Cleveland |
ClinicalTrials.gov Identifier: | NCT00487409 |
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 |
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Colonic Diseases Rectal Diseases |
Procedure: Bipolar electrosurgical generator and instruments Procedure: Disposable stapling instruments |
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 |
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 |
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Group A
Standard of Care
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Procedure: Disposable stapling instruments
laparoscopic colectomy using clips, cautery and stapler
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Group B
Standard of Care
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Procedure: Bipolar electrosurgical generator and instruments
laparoscopic colectomy using the Ligasure device
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michelle Briehl, RN, BSN | 216-844-4706 | michelle.briehl@uhhospitals.org |
Contact: Bridget Ermlich, RN, BSN | 216-844-3602 | bridget.ermlich@uhhospitals.org |
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 |
Principal Investigator: | Conor P. Delaney, MD, PhD | University Hospitals of Cleveland/ Institute for Surgical Innovation |
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 |
Ulcerative colitis Crohn's disease Colorectal polyps Colorectal malignancy |
Endometriosis Diverticulitis Colonic inertia |
Diverticulitis Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Crohn Disease |
Polyps Endometriosis Colitis, Ulcerative Intestinal Diseases Rectal Diseases Colitis |