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Colorectal SurgeryNCT00771290

Comparision of Air Versus CO2 for Distention During Sigmoidoscopy

A study testing Air insufflation with standard endoscopy unit, CO2 insufflation for colonoscopy (special CO2 insufflation unit) in people with Colorectal Surgery, run by Columbia University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Colorectal Surgery
What is being tested?
Air insufflation with standard endoscopy unit, CO2 insufflation for colonoscopy (special CO2 insufflation unit)
Type of treatment
Surgery or procedure
How many people
54 participants
Where
1 siteUnited States
Study dates
Mar 2008to Mar 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All patients, over age 18, undergoing elective, open or minimally invasive (laparoscopicassistedor handassisted) left sided colorectal resection, for any indication, in whom it is anticipated that a transanal circular,stapled colorectal anastomosis will be constructed will be eligible for enrollment in this study, provided they are able to understand and sign the Informed Consent Form. Patients will be identified preoperatively in anticipation of undergoing the operation detailed above.

Who cannot join

  • Patients undergoing right sided, transverse, or descending colectomy are not eligible since their anastomosis would not be carried out with a transanally placed circular stapler. Patients undergoing abdominoperineal resection (which includes no anastomosis) are also not eligible. Patients with severe COPD or emphysema would not be eligible for entry into this study. Further, patients who are undergoing emergent surgery or elective patients who are ASA Class 3 or 4 will not be eligible for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NewYork Presbyterian Hospital

    New York, New York, 10032

Other trials in United States

About this study

Official title: Prospective,Randomized Trial Comparing Colonic Distension After Intra-operative Sigmoidoscopy Using Ambient Air or Carbon Dioxide

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.

Read the detailed description

Colonoscopic examination of the large bowel (inserting a flexible endoscope with a camera at its tip through the anus and up into the rectum and colon) is sometimes required during a colorectal resection (abdominal operation to remove a segment or piece of colon or rectum) in order to find a small cancer, polyp, bleeding site, or simply to inspect the bowel after the two ends have been rejoined together. In order to get a good look at the large intestine with a colonoscope it is necessary to pump some gas into the colon via the scope in order to distend and inflate it. The gas that is almost universally used is room air. Since it is very hard, if not impossible, to fully suction out the gas from the colon once the exam is finished, the colon is usually quite bloated or distended after the colonoscopy. This dilatation can persist for hours or days since air is not well absorbed through the bowel wall into the body. A distended colon can cause some problems during both traditional open (big incision) surgery and laparoscopicassisted (minimally invasive) surgery. During a big incision operation, colonic distension and swelling can make it hard to close the incision at the end of the operation and can make breathing more difficult.

In contrast, during a laparoscopic procedure, the colorectal dilatation can greatly decrease the amount of working and maneuvering room that is available to the surgeon to the point where the laparoscopic approach may have to be abandoned in favor of the big incision method. Thus, colon distension following sigmoidoscopy done with air during an abdominal operation can cause problems for the patient and the surgeon.

An alternative gas that can be pumped into the colon during colonoscopy is carbon dioxide (CO2). Unlike air, CO2 is very rapidly reabsorbed into the body from the colon, about 250 times faster than air. There is now a machine available which makes it possible to easily and safely use CO2 gas to distend the colon during colonoscopy. The investigators believe that the use of CO2 during intraoperative 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. Patients undergoing either open (big incision) or laparoscopic (multiple small incisions) rectal or sigmoid colon resection usually need to have intraoperative sigmoidoscopy at the end of the operation to inspect the inside of the colon and rectum and to check for an air leak in the vicinity of the rejoining point (anastomosis). In this study one half of the patients will, by the flip of a coin, get CO2 during their sigmoidoscopy while the remaining half will have air used to inflated the colon during their examination. After the sigmoidoscopic exam is completed the scope will be removed, without suctioning, and the colon diameter near the rectum measured by the surgeons looking and working in the abdomen. The size of the colon will again be measured every 5 minutes for the next 20 minutes while the surgeons prepare to close the abdomen and end the surgery. At the end of the 20 minute period, if the colon remains distended, the scope will be reinserted and the excess gas suctioned out. The surgeons carrying out this study believe that the colons of those patients getting CO2 gas for the sigmoidiscopy will more rapidly shrink in size towards their original diameter than the patients who get air pumped into the colon.

Being tested
Air insufflation with standard endoscopy unit, CO2 insufflation for colonoscopy (special CO2 insufflation unit)
Keywords
Rectal sparing, Colon cancer
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Air insufflation with standard endoscopy unit, CO2 insufflation for colonoscopy (special CO2 insufflation unit)Procedure or surgery

    comparison of Air insufflation to CO2 insufflation during intraoperative endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. diameter of colon/rectal wall at surgery

    Measured: at surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJan 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00771290
Sponsor's protocol ID
AAAB6097
Status last verified
Apr 2024
First submitted
10 Oct 2008
Last updated
1 May 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Air insufflation with standard endoscopy unit, CO2 insufflation for colonoscopy (special CO2 insufflation unit) in people with Colorectal Surgery, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

diameter of colon/rectal wall at surgery (time frame: at surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.

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