Radiation protection in digestive endoscopy: European Society of Digestive Endoscopy (ESGE) guideline.

This article expresses the current view of the European Society of Gastrointestinal Endoscopy (ESGE) about radiation protection for endoscopic procedures, in particular endoscopic retrograde cholangiopancreatography (ERCP). Particular cases, including pregnant women and pediatric patients, are also discussed. This Guideline was developed by a group of endoscopists and medical physicists to ensure that all aspects of radiation protection are adequately dealt with. A two-page executive summary of evidence statements and recommendations is provided. The target readership for this Guideline mostly includes endoscopists, anesthesiologists, and endoscopy assistants who may be exposed to X-rays during endoscopic procedures.

Ulcerative colitis: no rise in mortality in a European-wide population based cohort 10 years after diagnosis.

BACKGROUND: Population based studies have revealed varying mortality for patients with ulcerative colitis but most have described patients from limited geographical areas who were diagnosed before 1990. AIMS: To assess overall mortality in a European cohort of patients with ulcerative colitis, 10 years after diagnosis, and to investigate national ulcerative colitis related mortality across Europe. METHODS: Mortality 10 years after diagnosis was recorded in a prospective European-wide population based cohort of patients with ulcerative colitis diagnosed in 1991-1993 from nine centres in seven European countries. Expected mortality was calculated from the sex, age and country specific mortality in the WHO Mortality Database for 1995-1998. Standardised mortality ratios (SMR) and 95% confidence intervals (CI) were calculated. RESULTS: At follow-up, 661 of 775 patients were alive with a median follow-up duration of 123 months (107-144). A total of 73 deaths (median follow-up time 61 months (1-133)) occurred compared with an expected 67. The overall mortality risk was no higher: SMR 1.09 (95% CI 0.86 to 1.37). Mortality by sex was SMR 0.92 (95% CI 0.65 to 1.26) for males and SMR 1.39 (95% CI 0.97 to 1.93) for females. There was a slightly higher risk in older age groups. For disease specific mortality, a higher SMR was found only for pulmonary disease. Mortality by European region was SMR 1.19 (95% CI 0.91 to 1.53) for the north and SMR 0.82 (95% CI 0.45-1.37) for the south. CONCLUSIONS: Higher mortality was not found in patients with ulcerative colitis 10 years after disease onset. However, a significant rise in SMR for pulmonary disease, and a trend towards an age related rise in SMR, was observed.

Ciprofloxacin inhibits cytokine-induced nitric oxide production in human colonic epithelium.

BACKGROUND: The fluoroquinolone ciprofloxacin is a broad-spectrum antibiotic that has been used in the treatment of inflammatory bowel diseases. There is evidence that quinolones have immunomodulating activities via the regulation of cytokine production. MATERIALS AND METHODS: We investigated the effect of ciprofloxacin on the nitric oxide (NO) production by colonic epithelium. HT-29 cells and colonic biopsies from patients (n = 4) with ulcerative colitis (UC) and normal controls (n = 4) were cultured with various concentrations of ciprofloxacin (10-100 microg mL(-1)) in the presence and absence of pro-inflammatory cytokines. The production of NO was measured in culture supernatants with a spectrophotometric method and inducible nitric oxide synthase (iNOS) mRNA expression was examined by reverse transcription-polymerase chain reaction (RT-PCR). RESULTS: Ciprofloxacin did not have any effect on the basal NO production by HT-29 cells. In contrast, ciprofloxacin significantly (P < 0.001) inhibited the pro-inflammatory cytokines (interleukin-1alpha + tumour necrosis factor-alpha + interferon-gamma)-induced NO production in HT-29, in a concentration-dependent manner, via the inhibition of the cytokine-induced iNOS mRNA expression. Wortmannin produced a concentration related reversal of the inhibitory effect of ciprofloxacin at both iNOS mRNA expression and NO production in HT-29 cells. A similar inhibitory effect of ciprofloxacin on the cytokine-induced NO production and iNOS mRNA expression was detected in vitro in cultures of normal colonic tissue. In addition, ciprofloxacin significantly inhibited the NO production and iNOS mRNA expression in cultures of colonic tissue from ulcerative colitis patients, in a concentration-dependent manner. CONCLUSIONS: These data suggest that ciprofloxacin, in addition to its antimicrobial role, might have an immunoregulatory effect on intestinal inflammation, via the modulation of inflammatory mediators.

European evidence based consensus on the diagnosis and management of Crohn's disease: special situations.

This third section of the European Crohn's and Colitis Organisation (ECCO) Consensus on the management of Crohn's disease concerns postoperative recurrence, fistulating disease, paediatrics, pregnancy, psychosomatics, extraintestinal manifestations, and alternative therapy. The first section on definitions and diagnosis reports on the aims and methods of the consensus, as well as sections on diagnosis, pathology, and classification of Crohn's disease. The second section on current management addresses treatment of active disease, maintenance of medically induced remission, and surgery of Crohn's disease.

Crohn's disease: increased mortality 10 years after diagnosis in a Europe-wide population based cohort.

BACKGROUND: No previous correlation between phenotype at diagnosis of Crohn's disease (CD) and mortality has been performed. We assessed the predictive value of phenotype at diagnosis on overall and disease related mortality in a European cohort of CD patients. METHODS: Overall and disease related mortality were recorded 10 years after diagnosis in a prospectively assembled, uniformly diagnosed European population based inception cohort of 380 CD patients diagnosed between 1991 and 1993. Standardised mortality ratios (SMRs) were calculated for geographic and phenotypic subgroups at diagnosis. RESULTS: Thirty seven deaths were observed in the entire cohort whereas 21.5 deaths were expected (SMR 1.85 (95% CI 1.30-2.55)). Mortality risk was significantly increased in both females (SMR 1.93 (95% CI 1.10-3.14)) and males (SMR 1.79 (95% CI 1.11-2.73)). Patients from northern European centres had a significant overall increased mortality risk (SMR 2.04 (95% CI 1.32-3.01)) whereas a tendency towards increased overall mortality risk was also observed in the south (SMR 1.55 (95% CI 0.80-2.70)). Mortality risk was increased in patients with colonic disease location and with inflammatory disease behaviour at diagnosis. Mortality risk was also increased in the age group above 40 years at diagnosis for both total and CD related causes. Excess mortality was mainly due to gastrointestinal causes that were related to CD. CONCLUSIONS: This European multinational population based study revealed an increased overall mortality risk in CD patients 10 years after diagnosis, and age above 40 years at diagnosis was found to be the sole factor associated with increased mortality risk.

Adjuvant chemotherapy for colon cancer.

Surgery remains the only curative therapy for colon cancer. However, several studies during the last years have proved that systemic chemotherapy in the adjuvant setting definitely improves the curative rate for those patients with localized colon cancer. The combination of 5-fluorouracil (5-FU) and leukovorin (LV) remained the reference treatment for over a decade. However, oxaliplatin-based chemotherapy has emerged as the new standard of care in adjuvant treatment of stage III colon cancer. The role of adjuvant therapy in stage II cancers remains controversial and its routine use is recommended only in high risk patients. This review focuses on the efficacy, safety and toxicity of several drugs used in the adjuvant treatment of colon cancer and on clinical issues, such as the timing for initiation of chemotherapy, its duration and treatment of special patient subgroups, such as stage II or elderly patients.

The inflammatory bowel disease questionnaire: a review of its national validation studies.

Health-related quality of life (HRQoL) is an important measure of illness perception on the part of the patient. The Inflammatory Bowel Disease Questionnaire (IBDQ) is a widely used questionnaire for HRQoL assessment in patients with inflammatory bowel diseases (IBDs). This questionnaire has been adapted and validated into several languages and cultural milieus. The aim of this study is to review the methods used by several adaptation studies for assessing the validity and reliability of the adapted IBDQ. A search was made of the Medline database for relevant articles since 1989. Standard validation criteria were used for including studies for further evaluation. The following aspects of the validation procedure were examined: translation, construct validity, reliability, sensitivity to change, and used statistical methods. Nine validation studies of the IBDQ, in England and in non English-speaking countries (Holland, Spain, Korea, Sweden, Greece, and China) were selected. All studies concluded that the adapted instrument was valid and reliable. Only few modifications were proposed. Two studies recommended the split of the four dimensions of the original questionnaire in five. Assessing HRQoL in patients with IBD is an ever-increasing practice, especially in clinical trials. IBDQ was proven to be valid and reliable in several cultural and linguistic milieus when appropriate validation procedures were applied.

Instruments for quality of life assessment in patients with gastrointestinal cancer.

Health-related quality of life (HRQoL) is a multi-dimensional concept, encompassing all aspects of patient health and used widely as an outcome measure in clinical trials. In this review, the current status of HRQoL assessment in clinical studies of gastrointestinal cancer is examined and the various instruments proposed for this purpose are considered and compared. The cancer-specific questionnaires, among them the Spitzer Quality of Life Index, the Rotterdam Symptom Check List, the Functional Living Index-Cancer, the Functional Assessment of Cancer Therapy General (FACT-G) and the Quality of Life Questionnaire of the European Organization for Research and Treatment in Cancer (EORTC), provide essential information about particular concerns of cancer patients and are most sensitive in detecting changes over time. The domain-specific questionnaires, among them the Multidimensional Fatigue Inventory, the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale and the Anorectal Sphincter-Conservative Treatment Questionnaire, are designed to assess one specific domain of quality of life. The core-module cancer-specific questionnaires combine a core questionnaire for use in any type of cancer with a module questionnaire which assesses specific issues in cancer patient subgroups. Such core-module instruments have been evaluated for colorectal, pancreatic, hepatobiliary, oesophageal and gastric cancer. The most valid and standardized instruments for HRQoL assessment in cancer patients are the EORTC and the FACT questionnaires, which are widely used in Europe and around the world. Data provided by these specific instruments complement clinical outcomes and may help to evaluate the costs and benefits of different treatment options, thus being essential to further improvement of treatment and care of cancer patients.

Urocortin in human gastric mucosa: relationship to inflammatory activity.

The presence of CRH and urocortin (Ucn), members of the CRH family of neuropeptides, was examined in human gastric biopsies from normal controls and in patients with active gastritis from Helicobacter pylori (H. pylori) and after eradication treatment. RT-PCR analysis showed the presence of the Ucn transcript in biopsies (obtained by gastroscopy) from normal and inflamed gastric mucosa, whereas the CRH transcript was not detectable. Immunoreactive (ir-) Ucn was localized (by immunohistochemistry) in gastric epithelial cells and in inflammatory elements of the surrounding negative for Ucn gastric stroma. The level of ir-Ucn was higher in gastric biopsies from the group of patients with active H. pylori gastritis than in normal controls (10.4 +/- 1.8 vs. 2.0 +/- 1.3 pg/ micro g total protein; P < 0.001). After the apparent eradication of H. pylori infection (by clinical and morphological criteria) ir-Ucn levels increased dramatically to 43.1 +/- 9.8 pg/ micro g total protein, (P < 0.001) compared with pretreatment values. Interestingly, nonresponders to the eradication treatment did not show any significant change in ir-Ucn levels (18.7 +/- 12.3 pg/ micro g total protein) compared with their pretreatment values. In conclusion, our data suggest that in human gastric epithelium Ucn is present and plays an important physiological role, whereas CRH is absent. In addition, and in contrast to what has been found for CRH in ulcerative colitis, a highly significant, but negative, correlation has been found between Ucn levels and gastric inflammation, suggesting that Ucn may exert an antiinflammatory effect in gastric mucosa.

Changing pattern of cytokeratin 7 and 20 expression from normal epithelium to intestinal metaplasia of the gastric mucosa and gastroesophageal junction.

It is currently unclear whether intestinal metaplasia at the esophagogastric junction and in the distal esophagus represent a continuum of the same underlying disease process, i.e., gastroesophageal reflux, or constitute different entities with a different pathogenesis. Biopsies below the Z line might show specialized epithelium in some patients and the question is whether this is another form of short segment Barrett's esophagus or whether it is related to a generalized atrophic process of the stomach. Data from recent studies regarding the expression of cytokeratin CK7 and CK20 in intestinal metaplasia (IM) found at the gastroesophageal junction are conflicting. Prompted by these data we undertook the present study: a) to evaluate the expression of CK7 and CK20 in IM of the gastric cardia and to compare the findings with those in patients with Barrett's esophagus and IM of the gastric corpus and antrum mucosa; and b) to evaluate the immunophenotype of non-intestinalized cardiac mucosa and to compare it with that of normal gastric epithelium. We studied the expression of CK7 and CK20 on biopsy specimens from patients with long-segment Barrett's esophagus (n=17) and surgical resection and biopsy specimens of gastric cardia (n=15), corpus (n=14) and antrum (n=22) from patients with histological evidence of IM. Eighty-four biopsy specimens from 42 patients (antrum n=15, corpus n=20, cardia n=7) without evidence of IM were studied as a control group. We observed an immunophenotype characterised by diffuse moderate to strong CK7 staining on the surface and crypt epithelium combined with strong CK20 staining on the surface and superficial part of the crypts in 94.1% (16/17) of the cases with long-segment Barrett's esophagus, but in none of the 36 cases with IM in distal stomach (antrum and corpus). IM in the gastric cardia expressed the immunophenotype seen in IM of the gastric mucosa in 93.3% (14/15) of the cases. On the other hand, normal cardiac epithelium expressed patchy strong CK7 staining on the surface epithelium and on both, superficial and deep parts of the pits combined with patchy strong CK20 staining on the surface epithelium and superficial pits, a feature permitting distinction of the normal cardiac epithelium from those of the normal gastric antrum and corpus epithelium. We conclude that the expression of cytokeratins 7 and 20 can be used to distinguish the origin of IM of the gastroesophageal junction. The CK7/20 immunophenotype of IM in the gastric cardia closely resembles that of the IM in the gastric antrum and corpus and is different from IM in long-segment Barrett's esophagus. In contrast, the CK7/20 immunophenotype of the cardiac epithelium is different from that of the gastric antrum and corpus mucosa, suggesting that cardiac epithelium might not be a native normal gastric epithelium but one that is acquired as a consequence of longstanding inflammation. Changing pattern of CK7 and CK20 expression from normal to intestinalized epithelium suggests that IM arising from cardiac epithelium might have distinctive features.

Diminutive polyps of large bowel should be an early target for endoscopic treatment.

BACKGROUND AND AIMS: Aim of the present study is to ascertain the importance of diminutive colorectal polyps and define the need for removal according to their characteristics and malignant potential. PATIENTS AND METHODS: A total of 4,723 patients who underwent colonoscopy were evaluated and 624 patients with 826 polyps were recorded. There were 352 patients with 443 diminutive polyps, studied according to their distribution. Of these, 371 were removed, histologically examined and correlated to patient characteristics and occurrence of synchronous neoplasms. RESULTS: Of the right colon polyps, 81/115 were diminutive, versus 362/711 of the left colon (p<0.0001). Adenomas were more common in patients over 50 years of age, (p<0.0001). In all colonic segments, diminutive adenomas prevailed over hyperplastic polyps, whereas the proportion of diminutive adenomas predominated in the right colon (p=0.0015). Adenomas were classified as tubular 39%, tubulovillous 55.7% and villous 5.3%. The degree of dysplasia was mild in 45.5%, moderate in 51% and severe in 3.5%. The prevalence of synchronous neoplasms was 37.4%. They were more frequently found in males over 50 years of age and in patients with diminutive adenomas compared to those with diminutive hyperplastic polyps (p=0.0078). CONCLUSIONS: The majority of right colon polyps are diminutive. The proportion of diminutive adenomas is higher in patients over 50 years and in the right vs left colon. Diminutive polyps should be removed taking into account the high prevalence of adenomas with a villous component and their significant degree of dysplasia.

Autonomic imbalance during the day in patients with inflammatory bowel disease in remission. Evidence from spectral analysis of heart rate variability over 24 hours.

BACKGROUND: Autonomic function in inflammatory bowel disease has not yet been studied by means of analysis of 24-hour heart rate variability. AIM: To measure heart rate variability in inflammatory bowel disease patients in remission. PATIENTS AND METHODS: Study population comprised 27 patients with inflammatory bowel disease in remission and 28 healthy, sex- and age-matched controls. Two frequency ranges were analysed: low frequency (0.06-0.15 Hz) and high frequency (0.15-0.40 Hz). RESULTS: Mean values of low frequency and low frequency/high frequency ratio were lower in patients than in controls (p < 0.001). High frequency in patients tended to be higher than in controls (p = 0.09). The only factor that had a marginal effect on heart rate variability indexes was age. In high frequency, there was a significant time effect (p = 0.001) for both groups. There was also a significant time effect in low frequency/high frequency ratio in both groups (p < 0.001). During daytime, the mean values in low frequency/high frequency ratio were lower in patients than in controls (p < 0.001). CONCLUSIONS: There is a shift in the autonomic balance in patients with inflammatory bowel disease in remission towards a condition of relative parasympathetic predominance, which, in the first place, reflects a sympathetic pullback. This imbalance has a circadian rhythm and it is more pronounced during the day.

Bolus somatostatin but not octreotide reduces hepatic sinusoidal pressure by a NO-independent mechanism in chronic liver disease.

BACKGROUND: Evidence exists that somatostatin and octreotide might have different effects on hepatic haemodynamics. AIM: The investigation of the effects of somatostatin and its octapeptide analogue, octreotide, on sinusoidal pressure measured by the wedged hepatic venous pressure in patients with cirrhosis or chronic hepatitis and the correlation with the levels of hepatic vein NO. METHODS: Patients were randomly assigned to receive an injection of either 250 microg somatostatin (n=14: cirrhosis six, chronic hepatitis eight) or an injection of 125 microg octreotide (n=19: cirrhosis nine, chronic hepatitis 10) during hepatic vein catheterization. Baseline wedged hepatic venous pressure was measured, followed by measurements at 2, 5, 10 and 15 min after the injection of the drug. Nitrites/nitrates of the hepatic vein were measured before the injection and after 15 min. RESULTS: Both agents showed a similar qualitative but a different quantitative haemodynamic profile. No change in the wedged hepatic venous pressure was observed during the first 2 min after the injection of both drugs. This was followed by a decrease: 18% at 5 min (N.S.), 23% at 10 min (P < 0.01) and 24% at 15 min (P < 0.01) for somatostatin. Octreotide induced a relatively smaller decrease in the wedged hepatic venous pressure: 8% at 5 min (N.S.), 20% at 10 min (P < 0.01) and 16% at 15 min (N.S.). Further analysis of the sub-groups of cirrhotic and chronic hepatitis patients revealed a different effect. In the sub-group of cirrhotic patients, somatostatin caused a maximum decrease of 34% at 15 min post-injection (P < 0.01), but octreotide failed to produce a significant change on the wedged hepatic venous pressure. In contrast, no change was observed in chronic hepatitis patients with either drug. No change in the hepatic vein concentration of NO after treatment was observed with either somatostatin or octreotide. Moreover, no correlation of the levels of NO with the wedged hepatic venous pressure values was found. CONCLUSIONS: This study shows that somatostatin is more effective than octreotide in acutely reducing the wedged hepatic venous pressure after bolus injection and the observed change is probably mediated by a NO-independent mechanism.

Quality of life of Greek patients with inflammatory bowel disease. Validation of the Greek translation of the inflammatory bowel disease questionnaire.

BACKGROUND/AIMS: Health-related quality of life (HRQOL) is an important outcome measure in inflammatory bowel disease (IBD). The aim of our study is to validate the Greek translation of the Inflammatory Bowel Disease Questionnaire (IBDQ). For this we assessed its construct validity, discriminant ability, reliability and sensitivity to change. METHODS: One hundred and fourteen patients with IBD (69 UC, 45 CD) completed the Greek version of the IBDQ, and a Visual Analogue Scale (VAS) for general well-being. Fifty-two patients also completed the SF-36. A subgroup of 46 patients completed the Greek IBDQ for a second time. Clinical activity was assessed by Harvey-Bradshaw Index and Colitis Activity Index. RESULTS: Correlation coefficients between the four dimensional scores of the Greek IBDQ and the clinical activity indexes, VAS and the SF-36 were all reasonably high and statistically significant. The Greek IBDQ was able to discriminate well between groups of patients with either different clinical disease activity or subjective assessment of well-being. It also showed high reliability when it was repeated in patients who reported no change in their general well-being (intraclass correlation coefficient 0.940-0.998). In contrast, there was a significant difference between the baseline and the follow-up measurement in patients who reported change in their general well-being. CONCLUSIONS: The Greek IBDQ proved to be a valid and reliable instrument for assessing HRQOL, useful in the evaluation of clinical trials or health surveys as well as in the therapeutic management of IBD patients.

Prospective evaluation of the impact of amoxicillin, clarithromycin and their combination on human gastrointestinal colonization by Candida species.

BACKGROUND: Amoxicillin and clarithromycin have been used extensively for the eradication of Helicobacter pylori. However, no study has examined the impact of their combination on the Candida albicans concentration of the gastrointestinal (GI) tract. This is the first study examining and comparing directly the effect of amoxicillin, clarithromycin and their combination on the C. albicans concentration of the human GI tract. METHODS: Thirty-three adult patients (11 in each antibiotic group) were studied prospectively. Quantitative stool cultures for Candida were conducted at the beginning, the end and 1 week after the discontinuation of antibiotic treatment. RESULTS: All three regimens increased the GI colonization in patients by Candida. The combination of amoxicillin with clarithromycin caused the highest increase; however, this was not statistically significant. CONCLUSION: Amoxicillin and clarithromycin used either alone or in combination cause a small to moderate increase in GI colonization by Candida. Hence, these drugs could be safely used in patients at risk for candidiasis originating from the GI tract.

Anti-Saccharomyces cerevisiae mannan antibodies and antineutrophil cytoplasmic autoantibodies in Greek patients with inflammatory bowel disease.

OBJECTIVES: The combined measurement of perinuclear antineutrophil cytoplasmic autoantibodies (pANCA) and anti-Saccharomyces cerevisiae mannan antibodies (ASCA) has recently been suggested as a valuable diagnostic approach in inflammatory bowel disease (IBD). The aim of this study was to assess the value of detecting pANCA and ASCA in the differentiation between ulcerative colitis (UC) and Crohn's disease (CD) in a Greek population with IBD. METHODS: Sera were collected from 157 patients with IBD (97 with UC, 56 with CD, and four with indeterminate colitis) and 150 healthy controls. Determination of pANCA was performed by a standard indirect immunofluorescence technique on ethanol-fixed granulocytes and ASCA by an ELISA assay. RESULTS: In patients with UC, sensitivity, specificity, positive predictive value, and negative predictive value of the pANCA test was 67%, 84%, 93%, and 46% respectively. These values did not change significantly when the combination of positive pANCA and negative ASCA was used. ASCA test in diagnosing CD yielded a sensitivity, specificity, positive predictive value, and negative predictive value of 39%, 89%, 54%, and 81%. The combination of pANCA negative and ASCA positive increased the positive predictive value to 77% and it was associated with small bowel disease. CONCLUSIONS: A positive pANCA test in Greek patients has a diagnostic value in confirming a diagnosis of UC. Measurement of pANCA and ASCA together has a rather limited value in the differential diagnosis between UC and CD but may be of help in studying disease heterogeneity.

Retroperitoneal fibrosis during the course of ulcerative colitis. A simple coincidence?

Retroperitoneal fibrosis has been described as a rare occurrence during the course of inflammatory bowel disease, mainly Crohn's disease. This is the third report on retroperitoneal fibrosis occurring during the course of ulcerative colitis. A 62-year-old male patient with a 5-year history of ulcerative colitis developed stenosis of the left ureter due to retroperitoneal fibrosis. Treatment consisted in surgically releasing the ureter from the mass and steroids. During a 2.5-year follow-up, renal function was stable and ulcerative colitis in remission. Important aspects of this case are the moderate course of ulcerative colitis, ultrasound confirmation of normal kidney structure before manifestation of fibrosis, hypertension diagnosed four years before retroperitoneal fibrosis, a non-functioning kidney at diagnosis, and reduction of retroperitoneal mass after steroid treatment. Retroperitoneal fibrosis, although a rare disease entity should be considered when a patient with ulcerative colitis develops otherwise unexplained renal insufficiency.

Resistance to activated protein C and low levels of free protein S in Greek patients with inflammatory bowel disease.

OBJECTIVE: Patients with inflammatory bowel disease (IBD) frequently suffer from thromboembolic events. A recently identified mechanism for thrombophilia, the poor anticoagulant response to activated protein C, has been suggested as one of the leading risk factors for thrombosis. The aim of this study was to evaluate the frequency of thrombophilic abnormalities, including activated protein C-resistance (APCR), in Greek patients with ulcerative colitis (UC) and Crohn's disease (CD). METHODS: Forty-eight patients with UC, 36 with CD, and 61 matched healthy controls (HC) were studied. Cases with presence of lupus anticoagulant, use of anticoagulants or heparin, and pregnancy were excluded. Disease activity in CD was evaluated by use of the Crohns Disease Activity Index (CDAI) score and in UC by the Truelove-Witts grading system. Plasma levels of protein C, free protein S, antithrombin III (AT-III), activated protein C resistance (APCR), and fibrinogen were determined in IBD patients, as well as in HC. All the cases and controls with abnormal APCR were further studied by genetic testing for the factor V Leiden mutation. RESULTS: Mean fibrinogen levels in UC and CD patients were significantly elevated (p<0.0001), compared with HC. The mean values of free protein S, as well as mean APCR, were significantly lower in UC and CD patients than in the HC (p<0.0001). Seven (five UC and two CD) of 84 IBD patients (8.3%) and three of the HC (4.9%) had the factor V Leiden mutation. No significant difference was observed for the other thrombophilic parameters. Fibrinogen levels and profound free protein S deficiency were found related to disease activity. CONCLUSIONS: Thrombophilic defects are common in Greek patients with IBD and they could interfere either in the disease manifestation or in the thrombotic complications.

Instruments for quality of life assessment in patients with inflammatory bowel disease.

BACKGROUND: Health-Related Quality of Life is an important measure of illness perception on the part of the patient. In this review, the current status of the Health-Related Quality of Life assessment in studies concerning inflammatory bowel disease is examined and the various instruments proposed for this purpose are considered and compared. METHODS: A search was made of the Medline database, for relevant articles since 1980. Standard criteria were used for including studies for further evaluation. RESULTS: All studies on measuring Health-Related Quality of Life in inflammatory bowel disease patients conclude that the instruments used were valid and reliable assessment tools. Valid instruments that have been proposed for the assessment of health-related quality of life are: the Inflammatory Bowel Disease Questionnaire, the Rating Form of Inflammatory Bowel Disease Patient Concerns, an Inflammatory Bowel Disease-specific questionnaire developed in Cleveland, the Ulcerative colitis and Crohn's disease Health Status Scales and a Disease-specific questionnaire developed in the University of Padova. CONCLUSIONS: Assessing health-related quality of life in inflammatory bowel disease patients is an ever-expanding practice, especially in clinical trials. The instruments that, currently, satisfy most demands for simplicity and validity are the Inflammatory Bowel Disease Questionnaire, reflecting primarily disease activity, and the Rating Form of Inflammatory Bowel Disease Patient Concerns which corresponds more to the psychological and social aspects of inflammatory bowel disease from the patient's point of view.