Variation of quality of colonoscopy in Italy over five years: a nation-wide observational study.

BACKGROUND/AIM: A nation-wide survey of colonoscopy practice carried out in 2004 showed disappointing data on colonoscopy quality in Italy. Present study was aimed prospectively at re-evaluating quality indicators of colonoscopy and their changes over a five-year-period. METHODS: The main features of each Endoscopy Unit and performance indicators on consecutive colonoscopies performed in a 2-week period were recorded. Variation of colonoscopy quality was assessed by comparing caecal-intubation and polyp-detection rates in present survey with those collected five-years before; statistical analysis was restricted to centres participating in both data collections. RESULTS: 6158 colonoscopies from 116 centres were evaluated; unadjusted caecal-intubation rate was 83.0%, with 21.6% centres reporting a value >90%; mean polyp-detection rate was 32.0% (range 9.6-71.2% across centres). To assess variation of performance indicators, 4452 procedures from 77 centres were compared to 3589 procedures performed five-years before, in the same centres. A significant difference between the two rounds of data collections was observed for both caecal-intubation (82.6% versus 80.9%, p=0.043) and polyp-detection (31.3% versus 28.1%, p=0.002). However, 52 centres maintained a caecal-intubation rate constantly <90%. CONCLUSIONS: Present data show that colonoscopy in Italy is still far below quality standards and that a significant improvement of practice did not occur over the last five years. Strategies to enhance colonoscopy quality should be pursued by professional societies.

Errors and near misses in digestive endoscopy units.

BACKGROUND: Not much is known about errors and near misses in digestive endoscopy. AIMS: To verify whether an incident report, with certain facilitating features, gives useful information about unintended events, only excluding errors in medical diagnosis. METHOD: Nine endoscopy units took part in this cross sectional, prospective, multicentre study which lasted for two weeks. Members of the staff were required to report any unintended, potentially dangerous event observed during the daily work. A form was provided with a list of "reminders" and facilitators were appointed to help. The main outcome measurements were type of event, causes, corrective interventions, stage of occurrence in the workflow and qualification of the reporters. RESULTS: A total of 232 errors were reported (two were not related to endoscopy). The remaining 230 amount to 10.3% of 2239 procedures; 66 (29%) were considered errors with consequences, 164 (71%) "near misses". There were 150 pre-operative errors (65%), 22 operative (10%) and 58 post-operative (25%). Corrective interventions were provided for 60 cases of errors and 119 near misses. Most of the events were reported by the nurses (106 out of 232, 46%). CONCLUSIONS: Short-term incident reporting focusing on near misses, using forms with lists of "reminders", and the help of a facilitator, can give useful information on errors and near misses in digestive endoscopy.

Diagnostic value of faecal calprotectin in unselected outpatients referred for colonoscopy: A multicenter prospective study.

OBJECTIVES: To evaluate the role of faecal calprotectin in consecutive outpatients referred for colonoscopy. METHODS: Outpatients undergoing colonoscopy at five participating institutions were eligible. Demographic and clinical data were collected. Faecal samples were tested at a single laboratory by means of a commercially available kit. RESULTS: We consecutively enrolled 870 patients. Mean levels of calprotectin were significantly higher in patients with neoplastic and inflammatory disorders when compared with subjects with a normal colonoscopy or trivial endoscopic findings. Elevated calprotectin levels (>50mg/dl) were detected in 85% of patients with colorectal cancer, and 81% of those with inflammatory conditions but also in 37% of patients with normal or trivial endoscopic findings. In patients referred for chronic diarrhoea, sensitivity and negative predictive value were 100% in detecting either any organic colonic disease. In patients referred for symptoms of "suspected functional origin" sensitivity and negative predictive value for colorectal cancer were also 100%. CONCLUSIONS: In unselected outpatients referred for colonoscopy, a single measurement of faecal calprotectin is not sufficiently accurate to identify those with significant colorectal disease. However, a normal result can help rule out organic disease among patients with diarrhoea and those with abdominal pain and/or constipation.

Patient satisfaction after endoscopic retrograde cholangiopancreatography for biliary stones: a prospective multicenter study in Lombardy.

AIMS: To measure patients' satisfaction after endoscopic retrograde cholangiopancreatography (ERCP) for biliary stones in a large number of unselected endoscopy units. METHODS: A prospective study using a questionnaire (Group Health Association of America-9 [GHAA-9], modified) was administered 24 h and 30 days after the procedure. Patients undergoing endoscopy for biliary stones for the first time were enrolled in a large number of endoscopy units, regardless of their size and workload. RESULTS: In all, 700 patients were enrolled in 15 units. A high proportion of patients expressed satisfaction (80%). Satisfaction was less extensive for pain control and the quality of information provided before the procedure. There were no differences in the replies to questionnaires at 24 h and 30 days. CONCLUSION: It is feasible to record patients' satisfaction and in this series most patients were very satisfied. Criticisms concerned pain control and explanations provided before the procedure.

Predictive factors of mortality from nonvariceal upper gastrointestinal hemorrhage: a multicenter study.

OBJECTIVES: From an Italian Registry of patients with upper gastrointestinal hemorrhage (UGIH), we assessed the clinical outcomes and explored the roles of clinical, endoscopic, and therapeutic factors on 30-day mortality in a real life setting. METHODS: Prospective analysis of consecutive patients endoscoped for UGIH at 23 community and tertiary care institutions from 2003 to 2004. Covariates and outcomes were defined a priori and 30-day follow-up obtained. Logistic regression analysis identified predictors of mortality. RESULTS: One thousand and twenty patients were included. A total of 46 patients died for an overall 4.5% mortality rate. In all, 85% of deaths were associated with one or more major comorbidity. Sixteen of 46 patients (35%) died within the first 24 h of the onset of bleeding. Of these, eight had been categorized as ASA class 1 or 2 and none of them was operated upon, despite a failure of endoscopic intention to treatment in four. Regression analysis showed advanced age, presence of severe comorbidity, low hemoglobin levels at presentation, and worsening health status as the only independent predictors of 30-day mortality (P < 0.001). The acute use of a PPI exerted a protective effect (OR 0.23, 95% CI 0.09-0.73). Recurrent bleeding was low (3.2%). Rebleeders accounted for only 11% of the total patients deceased (OR 3.27, 95% CI 1.5-11.2). CONCLUSIONS: These results indicate that 30-day mortality for nonvariceal bleeding is low. Deaths occurred predominantly in elderly patients with severe comorbidities or those with failure of endoscopic intention to treatment.

Technical performance of colonoscopy: the key role of sedation/analgesia and other quality indicators.

BACKGROUND: It is essential to identify the factors in clinical practice that influence the technical performance of colonoscopy as a basis for quality improvement programs. AIMS: To assess the factors linked to two key indicators of colonoscopy performance, i.e., cecal intubation and polyp diagnosis. DESIGN AND SETTING: Consecutives colonoscopies performed over a 2-wk period in 278 unselected practice sites throughout Italy were prospectively evaluated. A multivariate model was developed to identify determinants of the performance indicators of colonoscopy. RESULTS: In total, 12,835 patients (mean age 60.5 yr, standard deviation [SD] 15.1, 53% men) were studied. Sedation and/or analgesia was administered in 55.3% of procedures: 28.8% of patients received intravenous (IV) benzodiazepines, 15.4% received benzodiazepines in combination with narcotics, 3.1% received propofol, and 7.5% received other sedation regimens. Overall, cecal intubation was achieved in 80.7% of procedures, and the polyp detection rate was 27.3%. Multivariate analysis showed that the strongest predictors of cecal intubation were the quality of bowel preparation (inadequate vs excellent: odds ratio [OR] 0.013, 95% confidence interval [CI] 0.009-0.018; fair vs excellent: OR 0.246, 95% CI 0.209-0.290; and good vs excellent: OR 0.586, 95% CI 0.514-0.667) and the use of sedation (IV benzodiazepines vs no sedation: OR 1.460, 95% CI 1.282-1.663; IV benzodiazepines and narcotics vs no sedation: OR 2.128, 95% CI 1.776-2.565; and propofol vs no sedation: OR 2.355, 95% CI 1.590-3.488). The colonoscopy setting (workload and organizational complexity of the center) and the endoscopist colonoscopy volume were other factors independently correlated with completion of the procedure. Detection of polyps partially depended on the quality of bowel cleansing (inadequate vs excellent: OR 0.511, 95% CI 0.404-0.647) and use of sedation (OR 1.172, 95% CI 1.074-1.286). CONCLUSION: In usual clinical practice, the use of sedation/analgesia, the colon-cleansing quality, the endoscopist experience, and some features related to the colonscopy setting decisively influence the quality of colonoscopy. These factors indicate the targets of future corrective measures to boost the quality of this examination.

Tumour necrosis factor alpha in segmental colitis associated with diverticula.

The pathogenesis of segmental colitis associated with diverticula (SCAD) is unclear, but tumour necrosis factor alpha (TNF-alpha) has been shown to play a pivotal role in the pathogenesis of inflammatory bowel diseases. The aim of this study was to assess TNF-alpha levels in patients with SCAD. In a post hoc analysis of a prospective multicenter study, tissue samples from 13 patients diagnosed with SCAD were subjected to histological analyses. The severity of the inflammation was assessed by means of a histological score and histomorphometry (number of inflammatory cells/mm2). Immunohistochemical staining with an antibody against TNF-alpha was performed on all biopsies and the degree of staining expressed as the percentage of positive stromal cells/1000 counted (TNF-alpha score). Matched patients with irritable bowel syndrome (IBS) were used as controls. Over-expression of TNF-alpha was found in all SCAD patients (38.6 +/- 10.4%), and it was associated with a high histological score (2.5 +/- 0.5) and neutrophil cell count (16.3 +/- 3/mm2). These values were distinctly higher than those found in the IBS controls. Our data suggest that TNF-alpha activity is involved in SCAD pathogenesis, similarly to what occurs in Crohn's disease and ulcerative colitis.

Lack of colonic neoplastic lesions in patients under 50 yr of age with hematochezia: a multicenter prospective study.

OBJECTIVES: It is still not clear what is the best way of evaluating rectal bleeding in young people. Our aim was to examine the prevalence of neoplastic colonic lesions in these patients. METHODS: This prospective, multicenter study enrolled 622 patients aged 30-50 yr (F 232/M 390) consecutively seen in 14 open-access endoscopy departments for hematochezia, defined as bright red blood from the rectum, red blood noted either in the feces, on toilet paper, or in the toilet bowl. At colonoscopy, pathology was stratified as either proximal or distal to the splenic flexure. Exclusion criteria were a history of colitis, colorectal cancer, polyps, anemia, significant weight loss, severe bleeding, or strong family history of colorectal cancer. RESULTS: Malignant polyps were found in two patients (0.6%), aged 30-40 yr, one in the rectum and one in the sigmoid. A malignant polyp of the cecum was found in a 41-yr-old patient. Another, aged 47, had a malignant granular-cell tumor of the rectum. A total of 35 advanced adenomas were identified in 18 patients. In 7 patients (2.2 %) within the 30-40 yr age bracket we found 8 advanced adenomas (all in the rectum/sigmoid). The other 27 advanced adenomas were in 11 patients (3.5%) in the 41-50 yr age bracket. In this age group we observed 3 patients with 10 isolated proximal advanced adenomas. CONCLUSIONS: In patients younger than 40 yr with hematochezia, advanced neoplastic lesions are rare and usually located in the rectum and sigmoid colon. Sigmoidoscopy appears to be sufficient for evaluation in these patients.

Experts' opinions on the role of liver biopsy in HCV infection: a Delphi survey by the Italian Association of Hospital Gastroenterologists (A.I.G.O.).

BACKGROUND/AIMS: Liver biopsy represents the gold standard to establish a diagnosis in all liver patients, but its current position in chronic viral hepatitis is questioned. We aimed to create a consensus on best practice of use of liver biopsy in the management of chronic HCV infection. METHODS: We applied the Delphi method to 12 clinical scenarios of chronic HCV infection, to assess the extent of agreement (consensus measurement) and to resolve disagreement (consensus development) on the appropriateness of liver biopsy. RESULTS: Among 108 chosen hepatologists, 61 (56.5%) accepted to participate to the first-round survey. In four patients the majority of experts (from 61.4 to 86.2%) agreed not to perform liver biopsy; in two cases an equivalent opinion was found, and in the remaining six scenarios the majority of experts would have recommended a biopsy. No expert recommended liver biopsy in all cases, while most agreed for an histological evaluation of 4 to 8 cases. At the second round, 36 experts (59%) submitted ballots. Fifty-four out of 431 (12.6%) original judgments were changed with equal distribution among different scenarios. CONCLUSIONS: Our survey showed a great divergence of management of similar patients and should provide a stimulus for an evidence-based evaluation of liver histology in chronic HCV infection.

High-dose senna compared with conventional PEG-ES lavage as bowel preparation for elective colonoscopy: a prospective, randomized, investigator-blinded trial.

OBJECTIVE: To compare the efficacy and patient acceptance of an oral high dose of senna to conventional polyethylene glycol-electrolyte lavage solution (PEG-ES) in adults undergoing elective colonoscopy. METHODS: Consecutive outpatients referred for elective colonoscopy were prospectively randomly assigned to receive, the day before the procedure, either 24 tablets of 12 mg senna, divided into two doses at 1 p.m. and 9 p.m. (senna group, n=191), or standard 4-L PEG-ES (PEG-ES group, n=92). The overall quality of colon cleansing (primary outcome measure) and cleansing in the right colon were evaluated using the Aronchick scoring scale (1=excellent to 4=inadequate) by the investigator/endoscopist who was blinded to the treatment assignment. Patient acceptance and the safety of the preparation were assessed by a nurse, using a structured questionnaire covering compliance with the dosing, overall tolerance of the preparation (1=none or mild discomfort to 4=severely distressing), and adverse events. RESULTS: The quality of colon cleansing, overall tolerance of the preparation, and compliance were significantly better with senna; overall cleansing was excellent or good in 90.6% of patients in the senna group and in 79.7% in the PEG-ES group (p= 0.003). The percentage of procedures rescheduled because of insufficient colon cleansing was 7.3% in the PEG-ES group and 2.6% in the senna group (p=0.035). Multivariate logistic regression modeling showed the PEG-ES preparation as negative independent predictor of unsuccessful bowel cleansing. The incidence of adverse reactions was similar in the two groups; patients who received senna experienced significantly less nausea and vomiting, but more abdominal pain. CONCLUSIONS: An oral high dose of senna is a valid alternative to standard PEG-ES for outpatient colonoscopy preparation.

Is esophageal pH monitoring used appropriately in an open-access system? A prospective multicenter study.

OBJECTIVES: To evaluate the referral patterns and indications for esophageal pH monitoring in an open-access system and to determine whether these indications conform to practice guidelines of the American Gastroenterological Association (AGA). METHODS: A total of 851 consecutive patients referred for ambulatory pH monitoring to nine open-access gastrointestinal units over a 12-month period received a structured interview. The indication for the examination was decided by the physician performing the procedure, on the basis of the patient's clinical history and main complaint. RESULTS: Three hundred and twenty-three (38%) examinations were for indications in accordance with the guidelines. The proportion of appropriate requests in each center ranged from 34% to 47%. This figure was not significantly different in larger gastrointestinal units (more than 150 examinations per year) and smaller ones (35% and 40%; p= 0.14). The proportion of appropriate requests was 45% for gastroenterologists, 38% for surgeons, 32% for other specialists, and 24% for primary care physicians (PCPs) (p < 0.001). The percentage of appropriateness was significantly different between gastrointestinal specialists and PCPs (p < 0.001 vs gastroenterologists, p= 0.015 vs GI surgeons), and between gastroenterologists and other specialists (p= 0.006). The underuse of an empirical trial of acid-suppression therapy in patients with suspected reflux disease and the overuse of this test to confirm a diagnosis in patients with erosive esophagitis and in endoscopy-negative cases with typical symptoms responding completely to antisecretory therapy accounted for most of the referrals, which was not in accordance with the guidelines. CONCLUSIONS: In an open-access system, a high proportion of esophageal pH studies are done for indications not consistent with published guidelines, particularly among the examinations not requested by gastrointestinal specialists. Further education is still needed on the appropriate use of esophageal pH monitoring and management of gastroesophageal reflux disease (GERD).

Extended/advanced monitoring techniques in gastrointestinal endoscopy.

The practice of sedation and analgesia is under increasing scrutiny by numerous regulatory agencies, with the aim of making these procedures safer and reducing the incidence of cardiopulmonary complications during GI endoscopy. As we move toward more evidence-based medicine, new technologies will have to be assessed in a manner that demonstrates their efficacy and utility in clinical practice. Although there have been no controlled studies examining whether more intensive monitoring during endoscopy improves outcomes, extended monitoring with capnography seems to offer an advantage over conventional monitoring in that, by providing a real-time indication of any change in adequate ventilation before oxygen desaturation occurs, it can detect early phases of respiratory depression, which can allow a more precise and safer titration of medications. There is a close agreement among experts that capnography may reduce the risk of adverse outcomes during deep sedation; therefore, its use should be required for patients undergoing advanced endoscopic procedures with the potential for deep sedation. Extended monitoring with capnography should also be endorsed whenever propofol is considered as an alternative to standard sedation with a benzodiazepine or narcotic. Our understanding of the clinical application of techniques for monitoring of depth of sedation is in its infancy, and its full contribution to the practice of endoscopy has yet to be determined. Their potential role in improving sedation practice during endoscopy needs to be confirmed by controlled trials. If we consider the lack of proven efficacy of these emerging monitoring techniques in reducing the adverse outcomes associated with sedation and analgesia, the importance of appropriate monitoring cannot be overemphasized. However, it is vital for the endoscopist to be thoroughly familiar with the type of sedation chosen, to be able to recognize the various levels of sedation, and, above all, to rescue patients should they unintentionally progress to a deeper level of sedation than intended.

Single bolus of midazolam versus bolus midazolam plus meperidine for colonoscopy: a prospective, randomized, double-blind trial.

BACKGROUND: The aim of this study was to determine whether a single bolus of meperidine in addition to midazolam improves patient tolerance during colonoscopy. METHODS: Consecutive patients undergoing outpatient colonoscopy were randomly assigned in double-blind fashion to receive a single rapid intravenous bolus of 5 mg of midazolam and placebo (Group A, n = 125) or 5 mg midazolam plus 50 mg meperidine (Group B, n = 128). Tolerance (4-point scale: 1 excellent, 4 unbearable), pain (4-point scale: 1 none, 4 severe) and willingness to undergo another colonoscopy were assessed 24 to 48 hours later in a telephone interview conducted by an independent observer blinded to the regimen of sedative medication. RESULTS: Significantly more patients in Group A reported moderate or severe pain (28% vs. 9%; p < 0.001), poor or unbearable tolerance (18% vs. 6%; p < 0.01) and unwillingness to undergo colonoscopy again in the future (14% vs. 5%; p < 0.05). By multivariate analysis, randomization to the midazolam group and younger age were the only variables independently associated with the risk of reporting at least one of these outcomes. Recovery time, frequency of oxygen desaturation, and need for supplemental oxygen were not significantly different between the 2 groups. CONCLUSIONS: The addition of a single bolus of meperidine to midazolam improves patient tolerance and lessens pain during colonoscopy without significantly increasing the frequency of side effects or prolonging recovery time.