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



Status:Completed
Conditions:Colorectal Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:January 2006
End Date:December 2010

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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.

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.

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
We found this trial at
1
site
New York, New York 10065
Phone: 212-746-5278
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from
New York, NY
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