Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery
Completed · Not applicable
Conditions studied: Colonic Diseases, Rectal Diseases
In brief
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.
Key facts
- Study ID
- NCT00487409
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 100
- Starts
- 2006-12-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2014-12-15
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Hospitals of Cleveland Case Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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