Clinical trial NCT00725465: Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions
Official title: Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Polyps
Keywords: laparoscopy
CO2 colonoscopy
intraoperative CO2 colonoscopy
combined Lap-CO2 procedure
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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. Multiple measurments of Arterial Blood Gass will be performed and evaluated.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: arterial blood gas (ABG)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jeffrey W Milsom, MD
role: PRINCIPAL_INVESTIGATOR
References: