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 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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
arterial blood gas (ABG)	30 days

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Publications and helpful links

Helpful Links

• pubmed

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 24, 2008
• First Submitted That Met QC Criteria: July 29, 2008
• First Posted (Estimate): July 30, 2008

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: laparoscopy; CO2 colonoscopy; intraoperative CO2 colonoscopy; combined Lap-CO2 procedure
• Other Study ID Numbers: 0411007608

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No