Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions
Recruitment status was: Recruiting
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 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 ]
|Study Start Date:||January 2006|
30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions managed with intra-operative CO2 colonoscopy
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725465
|United States, New York|
|Weill Medical College|
|New York, New York, United States, 10065|