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

NCT00725465 | Completed

• 1 other identifier: 0411007608
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Polyps

Keywords

laparoscopy; CO2 colonoscopy; intraoperative CO2 colonoscopy; combined Lap-CO2 procedure

Outcome Measures

Primary Outcomes (1)

• arterial blood gas (ABG)

  30 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Medical College

New York, New York, 10065, United States

Location

Related Links

• pubmed

Study Officials

• Jeffrey W Milsom, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 30, 2008
• Study Start: January 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2010
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

US (1)