View Clinical Trial (Medical Research Study)
Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
| City: |
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Columbus |
| State: |
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Ohio |
| Zip Code: |
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43210 |
| Conditions: |
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Adenomatous Polyp - Crohn Disease - Familial Adenomatous Polyposis - Hereditary Intestinal Polyposis Syndrome - Recurrent Colon Cancer - Stage I Colon Cancer - Stage IIA Colon Cancer - Stage IIB Colon Cancer - Stage IIC Colon Cancer - Stage IIIA Colon Can |
| Purpose: |
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This study is being done to evaluate single incision laparoscopic surgery (SILS) for
colorectal diseases, compared to multi-port laparoscopic surgery. This study is also
intended to standardize the SILS technique for colorectal diseases
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| Study Summary: |
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PRIMARY OBJECTIVES:
I. To report the experience of SILS procedure in the treatment of colorectal disease.
II. To standardize the SILS technique.
OUTLINE:
Patients undergo single incision laparoscopic surgery with GelPort® attachment.
After completion of study treatment, patients are followed up at 2 weeks, 3 and 6 months,
and at 1 year.
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| Criteria: |
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Inclusion Criteria:
- Patients who are willing to give consent and comply with the evaluation and the
treatment schedule
- Patients with disease processes limited to the right colon; this will include Crohn's
disease, polyp disease, and cancers of the right colon
- American Society of Anesthesiologists (ASA) =< 3
Exclusion Criteria:
- Inability to obtain informed consent
- Previous right colon surgery
- Previous extensive abdominal surgery that would limit the laparoscopic approach
- Stage IV disease at surgery
- Metastatic disease diagnosed by computed tomography (CT), magnetic resonance imaging
(MRI), or nuclear imaging
- Patient enrolled in other interventional study
- ASA score greater than 3
- Any condition which precludes compliance with the study (Investigator discretion)
- Co-morbid condition(s) that could limit the subject's ability to participate in the
study or to comply with follow-up requirements, or that could impact the scientific
integrity of the trial
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| NCT ID: |
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NCT01656746 |
| Primary Contact: |
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Principal Investigator
David Renton, MD
Ohio State University
Ohio State University Comprehensive Cancer Center
Phone: 1-800-293-5066
Email: jamesline@osumc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Columbus, Ohio 43210
United States
David Renton, MD
Phone: 614-257-2264
Email: david.renton@osumc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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