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Comparision of Air Versus CO2 for Distention During Sigmoidoscopy

NCT00771290 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-05-01

No results posted yet for this study

Summary

Intra-operative colonoscopy (inserting a flexible endoscope with a camera at its tip through the anus and up into the rectum and colon) is most often indicated to locate or verify the location of small cancer, polyp, bleeding site, or simply to inspect the bowel after the two ends have been rejoined together. Usually colonoscopy utilizes ambient air to expand and inflate the colon and, as a result, leaves the colon bloated or distended until the gas is either expelled or absorbed. This endoscopy related bowel distension is problematic in the setting of both traditional open (big incision) colorectal surgery and after minimally invasive (laparoscopic assisted) procedures.

In the case of the former, it may prove difficult to close a traditional laparotomy incision if the bowel is distended and may hinder respiration with the abdomen closed. In the setting of a laparoscopic procedure, the bowel distension limits the working space available to the surgeon. Since the laparoscopic domain is limited, a distended colon following intra-operative colonoscopy can prevent the minimally invasive completion of a case (meaning that a conversion to traditional "open" methods would be necessary) that otherwise was going well with good prospects of laparoscopic completion. Colonic distension also causes abdominal pain and lengthens the recovery time from the procedure.

The investigators believe that the use of CO2 during intra-operative colonoscopy or sigmoidoscopy (exam of only the last 2 to 2 ½ feet of the colon) will not cause long lasting bloating or distension of the colon as opposed to air. Carbon dioxide is absorbed 250 times faster than ambient air and may decrease after procedure colonic distension. This prospective, randomized study will compare the two gases in terms of colonic distension. Patients undergoing open or minimally invasive colorectal resection will be randomized to undergo intra-operative colonoscopy using one of the two gases. Direct measurements of colon diameter will be taken at specific time intervals after the colonoscopy.

Conditions

  • Colorectal Surgery

Interventions

PROCEDURE

Air insufflation with standard endoscopy unit, CO2 insufflation for colonoscopy (special CO2 insufflation unit)

comparison of Air insufflation to CO2 insufflation during intraoperative endoscopy

Sponsors & Collaborators

Principal Investigators

  • Richard L Whelan, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-01-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00771290 on ClinicalTrials.gov