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NCT00771290 · ClinicalTrials.gov registry record · NA

Comparision of Air Versus CO2 for Distention During Sigmoidoscopy

A NA study, sponsored by Columbia University.

Terminated
Registry status
NA
Development phase
54
Enrollment target

NCT00771290 is a NA study that was terminated before completion, run by Columbia University. The registered enrollment target is 54 participants.

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The verdict

NCT00771290, a NA study, was terminated before completion, sponsored by Columbia University.

TERMINATED
Registry status
NA
Development phase
54 participants
Enrollment target

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 d

Interventions

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

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2008-03
Est. Completion 2009-03
Phase NA

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT00771290

The ClinicalTrials.gov registry entry for NCT00771290 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Air insufflation with standard endoscopy unit, CO2 insufflation for colonoscopy (special CO2 insufflation unit) is the first listed.

NCT00771290 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00771290 about?

NCT00771290 is a clinical study titled "Comparision of Air Versus CO2 for Distention During Sigmoidoscopy". 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...

What is the current status of trial NCT00771290?

This trial is currently terminated. It is a NA study. The enrollment target is 54 participants. The study started on 2008-03. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00771290?

The interventions under investigation include: Air insufflation with standard endoscopy unit, CO2 insufflation for colonoscopy (special CO2 insufflation unit) (PROCEDURE).

Who is sponsoring clinical trial NCT00771290?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.