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Trial record 56 of 671 for:    CARBON DIOXIDE AND arterial

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00725465
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease
Colorectal Polyps

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.


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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort
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.



Primary Outcome Measures :
  1. arterial blood gas (ABG) [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Locations
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United States, New York
Weill Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Jeffrey W Milsom, MD Weill Medical College of Cornell University

Additional Information:
pubmed  This link exits the ClinicalTrials.gov site

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00725465     History of Changes
Other Study ID Numbers: 0411007608
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
laparoscopy
CO2 colonoscopy
intraoperative CO2 colonoscopy
combined Lap-CO2 procedure