View Clinical Trial (Medical Research Study)
Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions
| City: |
|
New York |
| State: |
|
New York |
| Zip Code: |
|
10065 |
| Conditions: |
|
Colorectal Polyps |
| Purpose: |
|
The purpose of this study is to evaluate prospectively the usefulness of
IC-CO2(intraoperative colonoscopy (IC) using carbon dioxide (CO2)) in our colon and rectal
surgical practice, coincident with laparoscopic surgery, and assess whether it provides
useful information that influences the type of surgical therapy intended. We also wish to
further define the safety and extent of bowel distension when using IC-CO2. Furthermore, we
wish to evaluate the therapy and technique of using this combined approach to the treatment
of colorectal polyps and other localized, benign lesions of the large intestine. In this
study, the colonoscope is used both as a diagnostic and therapeutic tool, and is often used
in order to avoid a major bowel resection, yet effectively treat localized lesions of the
large intestine.
The hypothesis of this study is that IC-CO2 will provide useful information which does
affect surgical decision making at the time of operation, and that it is safe and does not
result in any significant bowel distention during or immediately after the procedure. We
additionally hypothesize that certain localized lesions of the intestines may be treated
using a combined laparoscopic-IC-CO2 approach to effectively treat the underlying disease,
minimize risks to the patient, and avoid a major bowel resection.
|
| Study Summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- All patients (male and female) greater than 18 years of age who undergo a
laparoscopic surgical procedure that utilizes intra-operative colonoscopy will be
approached to participate in this study
Exclusion Criteria:
- Patients under 18 year of age
- Patients with severe Renal Diseases
- Ascites
- COPD (severe)
- Liver insufficiency (severe) with coagulopathy
- Dialysis
- Sleep Apnea
- Patient pregnant
- Multiple previous surgeries
- Subject is incapable of understanding the informed consent
|
| NCT ID: |
|
NCT00725465 |
| Primary Contact: |
|
Jeffrey w Milsom, MD
Phone: 212-746 5278
Email: jwm2001@med.cornell.edu
|
| Backup Contact: |
|
Email: kivanova@med.cornell.edu
Koiana Trencheva, BSN
Phone: 212-746 5241
|
| Location Contact: |
|
New York, New York 10065
United States
Jeffrey W Milsom, MD
Phone: 212-746-5278
Email: jwm2001@med.cornell.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 19, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|