Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00771290 |
| Other study ID # |
AAAB6097 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2008 |
| Est. completion date |
March 2009 |
Study information
| Verified date |
April 2024 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
