The Patient Safety Authority has been tasked under the Mcare law to improve patient safety across the Commonwealth. One of our efforts to improve patient safety will be a focused review and suggestions for reducing the risk of a serious perioperative complication: perforation following colonoscopy.
During the first year of reporting, PA-PSRS received 125 reports of perforations of the colon during colonoscopy and another 27 reports in which the diagnosis was uncertain or the situation was otherwise unclear. These results indicate that between 125 to 152 perforations were reported as complications of colonoscopies during the first full year of reporting to PA-PSRS. The morbidity and cost of this complication is high. A colon perforation requires an emergency laparotomy for repair of the colon, sometimes with a colostomy. An additional consideration is that many of the patients who suffered this complication were reasonably healthy people who intended to undergo a diagnostic screening test.
According to PHC4, 322,867 colonoscopies (ICD9 = 45.23 or 45.25) were done in hospitals and ambulatory surgical facilities (ASFs) in Pennsylvania during that same period. Therefore, the rate of reported colon perforations that complicated colonoscopies was between 0.039% and 0.047%, or 1 out of every 2,583 to 2,124 colonoscopies.
We checked the possibility that duplicate reports of the same event were reported both by the instigating ASF and the receiving hospital; we found no duplications of age, gender, and date. Also, we know that perforations may occur in doctors’ offices and not be reported by the hospitals because they did not occur in a defined medical facility. Additionally, there may be under-reporting of events. However, most (83%) perforations are being reported as Serious Events, despite being “anticipated” as the most important complication of colonoscopy (i.e., discussed with patients during the consent process and on the mind of colonoscopists during procedures.
The rate of colon perforations during colonoscopies reported in PA-PSRS (0.039-0.047%) is low compared to the rates reported in the literature. For example, the Mayo Clinic in Scottsdale, Arizona, reported a perforation rate of 0.19%;1 a university teaching hospital in Canada reported a rate of 0.13%;2 and the Lehigh Valley Hospital reported a rate of 0.08%,3 as did the Mayo Clinic in Rochester, Minnesota.4 However, the number of perforations in the PA-PSRS database is high. For instance, of the literature that we reviewed, the largest number of perforations was 77, which occurred in a random sample of 5% of Medicare beneficiaries 65 years old or older in the Surveillance, Epidemiology, and End Results (SEER) program.5
Many patient and procedural factors have been proposed as risk factors for perforation of the colon during colonoscopy. Patient factors include pathology,6 intra-abdominal adhesions,6 and age,5 among others. Procedure factors include the mechanics of advancing the colonoscope,6 air insufflation,6 and the method of biopsy,6 again just to mention a few. Some of these risk factors can be controlled by the provider and some cannot. In theory, the risk of perforation of the colon during colonoscopy can be reduced by
identifying patient and procedural factors that could be modified to reduce the risk of perforation,
informing providers about these controllable risk factors, and
helping facilities implement programs to systematically control those risk factors during colonoscopies to minimize the risk of perforation.
Because of the number of reports and the morbidity of colon perforations, the Pennsylvania Patient Safety Authority Board of Directors has decided to undertake a focused objective cooperative analysis of perforations during colonoscopy as a special safety improvement project. The initial objective of this special initiative is to reduce the number of perforations during colonoscopies to at least less than 60 within a single year.
Facilities will notice this initiative in the following three areas and are encouraged to volunteer their commitment and full participation in this special safety improvement project:
The PA-PSRS team is looking for physicians and nurses of all specialties who do colonoscopy and who are interested in volunteering to provide their expertise and experience to this project.
- PA-PSRS will be soliciting detailed information from facilities in follow-up to reports of perforations during colonoscopies. Hopefully, facilities will understand the importance of gathering in-depth information on this complication; the burden will be small for any single facility, and the benefit large when the experience of the entire state is aggregated.
In order to understand which patient and procedure factors are not only commonly found with perforations, but more commonly found with perforations than with safe, uncomplicated procedures, it will be necessary to collect similar information on an equivalent-sized set of safely done procedures. The PA-PSRS team is looking for volunteer providers and facilities to provide this comparable information in order to identify the risk factors for perforation.
Armed with this information, the Authority will be able to identify controllable risk factors for perforation during colonoscopy, develop an educational program to inform Pennsylvania providers about these controllable risk factors, and assist them in developing system improvements to eliminate avoidable risks of perforation during colonoscopy.
To assist in this program, the PA-PSRS team will recruit an advisory panel. Members of the panel will represent various specialties and geographic areas. The advisory panel will help the PA-PSRS team develop a list of relevant questions, critique the analysis, advise the team on the development of an educational program, and suggest system improvements to create an effective risk-reduction program.
We will begin this special safety improvement program in January 2007.
Anderson ML, Pasha TM, Leighton JA. Endoscopic perforation of the colon: lessons from a 10-year study. Am J Gastroenterol 2000 Dec;95(12):3418-22.
Misra T, Lalor E, Fedorak RN. Endoscopic perforation rates at a Canadian university teaching hospital. Can J Gastroenterol 2004 Apr;18(4):221-6.
Tran DQ, Rosen L, Kim R, et al. Actual colonoscopy: what are the risks of perforation? Am Surg 2001 Sep:67(9):845-8.
Farley DR, Bannon MP, Zietlow SP, et al. Management of colonoscopic perforations. Mayo Clin Proc 1997 Aug;72(6):729-33.
Gatto NM, Frucht H, Sundararajan V, et al. Risk of perforation after colonoscopy and sigmoidoscopy: a population-based study. J Natl Cancer Inst 2003 Feb 5;95(3):230-6.
Damore LJ, Rantis PC, Vernava AM, et al. Colonoscopic perforations: etiology, diagnosis, and management. Dis Colon Rectum 1996 Nov:39(11):1308-14.