Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions
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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.
| Condition |
|---|
|
Colorectal Polyps |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions |
- arterial blood gas (ABG) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2006 |
| Groups/Cohorts |
|---|
|
30
30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions managed with intra-operative CO2 colonoscopy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions managed with intra-operative colonoscopy for standard care of their medical condition
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
Contacts and Locations| Contact: Jeffrey w Milsom, MD | 212-746 5278 | jwm2001@med.cornell.edu |
| Contact: Koiana Trencheva, BSN | 212-746 5241 | kivanova@med.cornell.edu |
| United States, New York | |
| Weill Medical College | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Jeffrey W Milsom, MD 212-746-5278 jwm2001@med.cornell.edu | |
| Contact: Koiana Trencheva, BSN 212-746 5241 kivanova@med.cornell.edu | |
More Information
No publications provided
| Responsible Party: | Jeffrey Milsom,MD, Weill Medical College |
| ClinicalTrials.gov Identifier: | NCT00725465 History of Changes |
| Other Study ID Numbers: | 0411007608 |
| Study First Received: | July 24, 2008 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
|
laparoscopy CO2 colonoscopy intraoperative CO2 colonoscopy combined Lap-CO2 procedure to evaluate simultaneous CO2 laparoscopy and colonoscopy safety and physiologic effects on patients from the additional CO2 insufflation |
Additional relevant MeSH terms:
|
Colonic Polyps Intestinal Polyps Polyps Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on June 18, 2013