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

18 Years
Not Enrolling
Colorectal Surgery

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Trial Information

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

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

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

diameter of colon/rectal wall at surgery

Outcome Time Frame:

at surgery

Safety Issue:


Principal Investigator

Richard L Whelan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

March 2008

Completion Date:

March 2009

Related Keywords:

  • Colorectal Surgery
  • Rectal sparing
  • Colon cancer
  • Dilatation, Pathologic



NewYork Presbyterian Hospital New York, New York  10032