How Often Do Screening Colonoscopies Result in a Complication?

Harlan Krumholz, MD is the director of the Yale Center for Outcomes Research and Evaluation (CORE). His team at Yale is being paid extraordinarily well to determine what works and what doesn’t in Medicare. Their data will theoretically allow Medicare to issue payment for services based on success rates of care without complications. His group is part of a national program promoted by the Center for Medicare Services (CMS) to spend less for more effective high quality care. This in my humble opinion is “voodoo” health care policy.

One of their areas of interest is trips to the emergency room or hospital within 7 – 14 days of a colonoscopy. They developed a formula to look at this problem and applied it to Medicare claims data in the year 2010 in NY, Nebraska, Florida and California. They found 1.6% of healthy individuals going for screening colonoscopy ended up at the hospital within seven days. They found wide variations in this rate coming from different facilities and different doctors. When the data is extrapolated to the 1.7 million Medicare beneficiaries undergoing screening colonoscopy annually it indicates there will be at least 27,000 unplanned hospital visits within seven days of the procedure.

Determining what causes complications of a screening procedure so we can determine a root cause and then prevent it is a good thing. However; the research needs to be done by independent groups not receiving funds from CMS which has a clear and strong conflict of interest!

We need to be looking at complications related to the choice of preparation, choice of colonoscopy, choice of anesthesia and whether polyps were removed and or biopsies taken. We additionally need to assess the definition of “low risk patient.”

Within the recommended age group for screening colonoscopies of 50-75 years old, very few patients are not taking prescription medications as well as supplements. The research needs to look at procedures such as CT Scan virtual colonoscopy and fecal immunochemical human occult blood testing as well for efficacy and complication rate.

There are currently DNA analysis tests of columnar epithelium colon cells sloughed during a normal bowel movement. Pre-cancerous polyps and colon cancer have distinctive DNA patterns that can be detected by looking at fecal material. There is no prep but the cost of $500 makes determining if it works and under what circumstances important. If it works then shouldn’t it be the screening test to determine who needs to have a colonoscopy? Yes, the research must be done but it must be done by agencies not affiliated with CMS with their stated goal of spending less for better service and better quality.

A Blood Test for Irritable Bowel Syndrome?

Researchers presented a paper at the annual Digestive Disease Week meeting which introduced a commercial blood test which can help distinguish irritable bowel syndrome (IBS) from Cohn’s Disease or Ulcerative Colitis (Inflammatory Bowel Diseases) and Celiac Disease ( Gluten Sensitive Enteropathy). The test was especially effective in identifying the diarrhea predominant form of Irritable bowel syndrome. The issue was discussed today on line in the periodical MedPage Today.

Patients with Irritable Bowel Syndrome get sudden abdominal bloating, cramping and progressively watery loose bowel movements. The symptoms often occur after a meal and leave the patient frightened and exhausted. Symptoms can be prolonged and emotionally and physically incapacitate an individual. Until now physicians were forced to schedule barium enemas, small bowel x ray series and fiber optic examinations (sigmoidoscopies, colonoscopies, upper endoscopies) to distinguish irritable bowel syndrome from the more ominous inflammatory bowel diseases. Very often we needed to collect stool specimens to look for white blood cells, red blood cells, bacteria, parasites and chemical constituents. The cost, radiation exposure and risks of invasive procedures causing complications made the experience expensive and unpleasant but necessary.

The current blood tests, used in a trial of 2700 patients, detect antibodies to cytolethal distending toxin B and vinculin. Mark Pimental, MD of Cedars-Sinai Medic al Center in Los Angeles said to the tests were successful in distinguishing IBS from the other entities with specificity well above 90% and a positive predictive value of 98.6% allowing clinicians to rule out Crohn’s Disease or Ulcerative Colitis.

This is a step in the right direction but it remains to be seen when the test will be available locally through commercial labs and if it really will allow us to eliminate the many tests we now do to distinguish these problems from one another.

Real Food for Colonoscopy Preparation

Colonoscopies save lives. It is recommended that adults start having them at age 50 to detect pre malignant colon abnormalities and early colon cancer. For the physician performing the test, the colon must be clean of digested food and stool to observe the lining cells of the colon. The presence of fecal material blocks the view of the colonic mucosa. Those of us who have taken screening colonoscopies are well aware that the preparation for the test is far worse than the actual procedure (which you are usually sedated for in some manner.) Most colonoscopy preps involve starting a laxative the afternoon before the procedure and staying on clear liquids the whole day until the procedure is complete. Some preps ask you to drink large volumes of soapy flavored liquids. Others use smaller quantities of chemicals but the end result is frequent loose and watery stools until the stool looks the same on the way out as it does on the way in. At best the preparation is a necessary but unpleasant experience.

Corey Siegel, MD MS and Dough Knuth, RD along with Joshua Korzenik, MD, of Harvard Medical School have produced real food laced with PEG-3350 as a colonoscopy prep. They are so confident of this preps efficacy that they formed a company to produce it called Colonary Concepts Inc. Foods such as pasta, pretzels with dipping sauce, smoothies and nonalcoholic Pina coladas have been mixed with laxatives to produce a colonoscopy prep. They reported on their study results at Digestive Disease Week and in MedPage Today. According to the endocscopists who performed the studies on these patients, the colon was good to excellent in preparation for viewing. The patients had no problems with the prep and said they would gladly choose the real food prep again for future colonoscopies. Based on the favorable review of this prep a larger Phase II study is now in progress. This is a step forward for a necessary but uncomfortable screening procedure.

March Is Colon Cancer Awareness Month

Colon CancerColon Cancer is still the second leading cause of death from cancer in the United States despite numerous advances in screening and early detection. It is a disease that is found more commonly in black Americans with 46.7 cases per 100,000 individuals as compared to 38.9 cases per 100,000 individuals for Caucasian Americans. Death from colorectal cancer occurs in every 21.1 cases for African Americans and only 14.6 cases for white Americans.

Even with these dismal figures the cancer death rate from this disease has decreased by 22 percent over the last decade. We attribute this to increased awareness and increased screening.

All individuals should report a change in bowel habits to their doctor immediately. Blood stained stool is a cause for an immediate call to your physician. Generally at age 40 all adults should be having a digital rectal examination as part of a checkup. Stool occult blood slides or stool fecal immunoglobulin slides are used to screen for microscopic gastrointestinal tract bleeding. These tests involve placing a small smear of stool on a slide and submitting it to the lab where it is tested for microscopic blood loss. Usually a CBC or complete blood count is performed as well since gastrointestinal blood loss in small constant amounts usually produces a low blood count or anemia of the iron deficient variety.

Screening colonoscopies are recommended for all non-Black Americans at age 50. Due to the increased risk of colon cancer in Black Americans we recommend that they start screening colonoscopies at age 45. If you have a first degree relative who had colon cancer or precancerous polyps we ask that you start your screening at an age that is 10 years earlier than your relatives disease became apparent.

For those individuals unwilling to have a screening colonoscopy we can offer a CT Virtual Colonoscopy. The preparation is simpler than for a colonoscopy but the radiation dosage involved is equivalent to receiving ten years’ worth of chest x-rays all at once. If the virtual colonoscopy shows a polyp or a mass you will then need to undergo a traditional colonoscopy for biopsy and removal preceded by a traditional pre- colonoscopy bowel cleansing prep.

Cologuard is a new and attractive stool test that detects abnormal DNA associated with premalignant polyps and cancerous tumors. It is fairly new but readily available.

Numerous lifestyle choices can influence your development of colon cancer. Tobacco use is associated with an increased risk, as is drinking more than moderate alcohol. Red meat intake is associated with an increased risk of colon cancer with a 20% increase per 100 gram increase in red meat per day. Regular exercise and intake of high fiber food helps to decrease your risk of developing colon cancer.

March is colon cancer awareness month. Speak to your physician about your risk of developing this serious disease and ways to prevent it from developing. You can use the visit to establish your own personalized colon cancer screening surveillance schedule.

New Test for Colon Cancer Screening Approved

Colon Cancer RibbonThe Cologuard test is the first DNA based screening test for colorectal cancer that has received approval for use from the FDA and preliminary approval by Medicare to cover the cost of the test. The test detects hemoglobin ( a component of red blood cells) and abnormal DNA in cells picked up by stool . A positive test indicates a need for colonoscopy to identify or eliminate colon cancer as a possibility. We currently screen patients with the fecal occult blood slide test and the more sophisticated fecal immunochemical test or FIT. The new Cologuard detected 92% of colon cancers and 42% of advanced adenomatous colon polyps as compared with 74% and 24 % for FIT. While the Cologuard test was accurate in picking up more colon cancers than the FIT it had slightly more false positive tests than the traditional Fecal Occult Blood Slide.

The Center for Medicare Services ( CMS) is proposing allowing coverage of the DNA test once every three years for beneficiaries who are 50 – 85 years old, asymptomatic and have average risk of colorectal cancer. The new test adds another non-invasive means of screening for colon cancer. We will need to see the cost of the test to the individual patient and accumulate more data on its accuracy in the near future before it becomes a mainstay of colon cancer screening.

At the same time that Cologuard was approved, researchers at the University of Michigan in Ann Arbor published in the online journal Cancer Prevention Research, information showing that evaluation of the pattern of bacteria in the colon of patients improved performance and detection of colon cancer by more than 50% as compared to the Fecal Occult Blood Test alone. Researchers using DNA sequencing and polymerase chain reaction methods were able to identify distinctly different patterns of bacteria in colon cancer and pre-cancerous polyps than in patients with no colon lesions.

It is clear that as researchers apply DNA technology to cancer screening their ability to detect abnormalities and avoid invasive colorectal screening will improve. At the moment recommendations for screening colonoscopy at age 50 remain but as science moves forward that too may soon change.

Traditional Colonoscopy vs. No Laxative CT Colon Exam

Research radiologists at the Massachusetts General Hospital in Boston evaluated the accuracy and detail of imaging the colon (a virtual colonoscopy or colonography) with no laxatives as preparation and comparing it with traditional colonoscopy.  There are clear evidence based guidelines suggesting that all low-risk men and women have a screening for colon cancer with a colonoscopy at age 50.  If that study is normal they are directed to repeat it every 10 years.  Routine screening colonoscopies are discontinued after age 80 years old.  There is no question that screening colonoscopies save lives from colon cancer.  There is no question that the laxative taken the day before to clean you out, plus the actual procedure, are reasons that individuals avoid going for colon cancer screening.

The study directors fed their patients a low fiber diet before the scan. The patients drank an oral contrast material that marked stool feces and allowed the radiologists to distinguish colon abnormalities from retained feces and stool.  This virtual colonography was excellent at detecting larger colon adenomas of 10 mm or larger picking up 91% of the existing lesions as compared to 95% with traditional preparation and colonoscopy. The difference between the 91% on virtual colonography and 95% on traditional prep and colonoscopy was not felt to be statistically significant.   The virtual colonography didn’t do as well at detecting the smaller growths.  Researchers pointed out that “the vast majority of polyps that impact cancer and survival outcomes are 10 mm or larger.”  They went on to say that the “the laxative free method would likely be worthwhile as a way to reach the many adults whose strong aversion to laxative bowel preparations stops them from getting screened.”

Clearly getting screened is always preferable to no screening.   The laxative free virtual colonoscopy was not as good as the traditional colonoscopy at finding smaller lesions.

The data in this research study were based on the skill and experience of three radiologists only. Previous studies have emphasized the need to have an experienced radiologist interpret these studies.  The researchers did not discuss the radiation exposure, which is significant, with the virtual colonoscopy.   They additionally did not mention the cost which many health insurance companies will not pay for at this time.

Despite these issues it is wonderful to have another tool in the fight against colon cancer especially to offer to those patients who have said they will “never” have a colonoscopy.

Screening Colonoscopy

A recent study proved what physicians and scientists suspected for years – early detection of colon cancer by screening colonoscopies saves lives. The current guidelines call for asymptomatic individuals to begin having a digital rectal exam at age 40. If there are no high risk situations for the patient then it is recommended that they start having screening colonoscopies at age 50. If their screening colonoscopy is negative then they can start scheduling follow-up colonoscopies for screening purposes every ten years.

Experts are now suggesting we stop performing screening colonoscopies at age 80.  At that age, the risk of a complication from the preparation for the test, plus the risk of a complication of the test (primarily perforation of the colon) make the risks far higher than the benefits. We certainly would continue to screen with annual digital rectal exams, and fecal occult blood tests, but the decision to perform a colonoscopy would be individualized based on the patients health, quality of life and expected longevity.

For high risk individuals, those with inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis), a history of polyps or a family history of colon cancer or inflammatory bowel disease the schedule is more stringent and starts earlier. The same would apply to individuals with a family history of premalignant colon polyps.  The interval of time between colonoscopies is shortened as well. For example, if a patient had a first degree relative who developed colon cancer at age 50 we would start screening that patient at age forty.

Recent studies and evaluations of screening colonoscopies have actually shown that primary care physicians are recommending colonoscopies too frequently with too short of a time interval between studies.  If you are low risk and have no symptoms you begin at age 50 and space the colonoscopies every ten years if the studies are negative.

Within the past few years radiologists have developed the CT Colonoscopy. The prep is less arduous than a traditional colonoscopy. The films, when read by an experienced radiologist, are as detailed and accurate as a fiber-optic traditional colonoscopy. The down sides are the amount of radiation you are exposed to and the need to do a traditional colonoscopy to biopsy any suspicious lesions found on the CT Colonoscopy. Cost is a factor as well with many insurance companies refusing to use this technology for screening purposes.

“Colonoscopies Are Overdone In The Entire Population.”

Current recommendations by the American College of Gastroenterology call for colonoscopy as a screening test for colon cancer beginning at age 50 for Caucasians and 45 years old for African Americans. If the initial test is negative, and you have no symptoms, the recommended interval for follow-up colonoscopy is 10 years.  Despite this, a recent study published in the Archives of Internal Medicine revealed that nearly half of the the Medicare patients with negative findings on colonoscopy underwent repeat exams much sooner than the guideline recommended interval of 10 years.

The study looked at 24,000 Medicare enrollees who had a negative colonoscopy from 2001 through 2003.  Forty six percent of these individuals had a repeat exam in less than seven years.  According to lead author James S. Goodwin, M.D. of the University of Texas Medical Branch in Galveston, there was “no clear indication for the early repeated examination “in just under half of the recipients.   He said that even in patients 80 years of age and older repeat exams were done within 7 years in 32.9 % of the study group even though these patients were much more likely to die of something other than colorectal cancer in the near future.

Goodwin and his associates were surprised by the frequency of the repeat colonoscopies since Medicare regulations preclude reimbursement for screening colonoscopy within 10 years of a negative examination result. Despite this, only 2% of the repeat exams were denied by Medicare and not paid.

Brooks Cash, M.D., chief of medicine at the National Naval Medical Center in Bethesda, MD said, “I think colonoscopies are overdone in the entire population. “  He believes some of the frequent studies are provider driven and many are patient driven.

Colonoscopy is an invasive test with risks. The preparation can lead to fluid and electrolyte and volume problems in some individuals and the chance of a bowel perforation is rare but always present.  Patients need to talk to their personal physician about the need for a follow-up colonoscopy and the appropriateness of the timing suggested by the gastroenterologist before scheduling one.