Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00725465
First received: July 24, 2008
Last updated: March 7, 2012
Last verified: March 2012

July 24, 2008
March 7, 2012
January 2006
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arterial blood gas (ABG) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00725465 on ClinicalTrials.gov Archive Site
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Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions
Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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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

Colorectal Polyps
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30
30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions managed with intra-operative CO2 colonoscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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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
Both
18 Years and older
No
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
 
NCT00725465
0411007608
No
Jeffrey Milsom,MD, Weill Medical College
Weill Medical College of Cornell University
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Weill Medical College of Cornell University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP