Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions
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|ClinicalTrials.gov Identifier: NCT00725465|
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : July 30, 2019
|Condition or disease|
The purpose of this study is to evaluate prospectively the usefulness of IC-CO2(intraoperative colonoscopy (IC) using carbon dioxide (CO2)) in colon and rectal surgical practice, coincident with laparoscopic surgery, and assess whether it provides useful information that influences the type of surgical therapy intended. Investigators will further define the safety and extent of bowel distension when using IC-CO2. Furthermore, the investigators will 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 Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||December 2010|
LAP surgery with CO2 colonoscopy
30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions such as neoplasm or rectal prolapse managed with intra-operative carbon dioxide (co2)colonoscopy for standard care of their medical condition.
- arterial blood gas (ABG) [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725465
|United States, New York|
|Weill Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Jeffrey W Milsom, MD||Weill Medical College of Cornell University|