William T. Depew

Predictive value of the rome criteria for diagnosing the irritable bowel syndrome

Objective:Our aim was to examine the predictive value of the Rome criteria and absence of so-called “red flags” of clinical practice for diagnosing irritable bowel syndrome. Red flags were relevant abnormalities on physical examination, documented weight loss, nocturnal symptoms, blood in stools, history of antibiotic use, and family history of colon cancer.Methods:In retrospective studies, 98 patients who had one or more Rome criteria and lacked red flags were identified by chart review of a 1-yr period. In prospective studies, 95 patients were identified who met the Rome criteria and lacked red flags. Sensitivity, specificity, predictive value of Rome criteria, and absence of red flags were determined. Consultants final diagnosis was the gold standard. Investigations before and after referral were recorded and reason for referral was determined in prospective studies.Results:In the retrospective series, the Rome criteria and absence of red flags had a sensitivity of 65%, specificity of 100%, and positive predictive value of 100%. None of these patients required revision of their diagnosis during a 2-yr follow-up. In the prospective study, the positive predictive value was 98%. More than 50% of the patients in this group had been referred because of diagnostic uncertainty and 24% had had an abdominal ultrasound; 66% of those <45 yr old underwent at least partial colonic evaluation.Conclusion:These findings suggest that the Rome criteria combined with a lack of red flags have a very high predictive value for diagnosing irritable bowel syndrome. Application of these diagnostic criteria has the potential to alter utilization of health care resources.

The IBS-36: A new Quality of Life measure for irritable bowel syndrome

OBJECTIVE:We aimed to develop and validate a quality of life instrument for patients with irritable bowel syndrome (IBS).METHODS:Using focus groups, existing questionnaires, and literature reviews, five IBS patients and nine gastroenterologists compiled and pilot tested for content validity a 70-item questionnaire. The questionnaire was then administered to 107 IBS patients, and using these data, the 70-item questionnaire was reduced to 36 questions through statistical and consensus methodology. The IBS-36 questionnaire was tested for construct validity, reliability, reproducibility, and responsiveness using a gold standard of structured interviews by three gastroenterologists, the Medical Outcomes Study Short Form Quality of Life Questionnaire, and the Coping Resource Inventory.RESULTS:The IBS-36 consists of 36 questions scored on a 7-point Likert scale. It has a very high internal consistency (Cronbachs α= 0.95) and a high test-retest reliability (Spearmans r= 0.92) and correlates as hypothesized with the Medical Outcomes Study Short Form Quality of Life Questionnaire (p < 0.001), McGill pain scores (p < 0.001), and IBS patient-reported sleep, symptom, and pain scores (ps = 0.030, <0.001, and <0.001, respectively).CONCLUSIONS:The IBS-36 addresses all areas of quality of life affected by IBS and is easy to administer and score. The IBS-36 is a well-validated, condition-specific quality of life measure for IBS patients that is sensitive to clinical intervention and highly correlated with established quality of life measures and patient-reported symptom scores.

Canadian Consensus on Medically Acceptable Wait Times for Digestive Health Care

BACKGROUND Delays in access to health care in Canada have been reported, but standardized systems to manage and monitor wait lists and wait times, and benchmarks for appropriate wait times, are lacking. The objective of the present consensus was to develop evidence- and expertise-based recommendations for medically appropriate maximal wait times for consultation and procedures by a digestive disease specialist. METHODS A steering committee drafted statements defining maximal wait times for specialist consultation and procedures based on the most common reasons for referral of adult patients to a digestive disease specialist. Statements were circulated in advance to a multidisciplinary group of 25 participants for comments and voting. At the consensus meeting, relevant data and the results of voting were presented and discussed; these formed the basis of the final wording and voting of statements. RESULTS Twenty-four statements were produced regarding maximal medically appropriate wait times for specialist consultation and procedures based on presenting signs and symptoms of referred patients. Statements covered the areas of gastrointestinal bleeding; cancer confirmation and screening and surveillance of colon cancer and colonic polyps; liver, biliary and pancreatic disorders; dysphagia and dyspepsia; abdominal pain and bowel dysfunction; and suspected inflammatory bowel disease. Maximal wait times could be stratified into four possible acuity categories of 24 h, two weeks, two months and six months. FUTURE DIRECTIONS Comparison of these benchmarks with actual wait times will identify limitations in access to digestive heath care in Canada. These recommendations should be considered targets for future health care improvements and are not clinical practice guidelines.

Carbohydrate-electrolyte rehydration protects against intravascular volume contraction during colonic cleansing with orally administered sodium phosphate

BACKGROUND Colonic cleansing with sodium phosphate causes intravascular volume contraction in some patients. This study tested the hypothesis that carbohydrate-electrolyte oral rehydration would attenuate the hypovolemic changes associated with administration of sodium phosphate. METHODS Adult outpatients were randomized to ingest either regular clear fluids or a carbohydrate-electrolyte rehydration solution during precolonoscopy purgation by ingestion of aqueous sodium phosphate. Investigators were blinded to the treatment assignment of patients. Clinical hemodynamic measurements and biochemical tests were obtained at baseline and after bowel preparation. Tolerability and colonoscopic visualization were assessed with questionnaires. RESULTS One hundred sixty-eight patients completed the study (81 clear fluids, 87 rehydration). By comparison with clear fluids, rehydration resulted in significantly less intravascular volume contraction. Changes in estimated central venous pressure and orthostatic pulse were significantly greater in the clear fluid group versus the rehydration group (p < 0.03). Changes in biochemical parameters after purgation also suggested a greater degree of volume contraction in the clear fluid versus rehydration group. Colonoscopic visualization was superior in the rehydration versus clear fluid group (p < 0.01); tolerability of the preparations was similar between groups (p = 0.2). CONCLUSIONS Carbohydrate-electrolyte rehydration protects against intravascular volume contraction during preparation for colonoscopy by ingestion of sodium phosphate. This approach is well tolerated by patients and improves colonic cleansing.

A prospective randomized trial comparing low-dose oral sodium phosphate plus stimulant laxatives with large volume polyethylene glycol solution for colon cleansing.

This study examined whether the combination of a single dose (45 ml) oral sodium phosphate (NaP), four bisacodyl tablets (5 mg), and one bisacodyl enema (10 mg) preparation, Fleet Prep Kit 3 (FPK #3), was better tolerated and more efficacious than 4 L polyethylene glycol solution (PEG) for colonic cleansing prior to colonoscopy. One hundred and seventy-one patients were enrolled in this prospective, randomized, single-blinded study designed to detect a 20% or greater difference in patient tolerance and effectiveness in colonic cleansing between the two agents. The single dose of NaP and the bisacodyl tablets were administered at 1900 h and at 2100 h, respectively, the evening prior to colonoscopy and the bisacodyl enema 2 h before the procedure. PEG was consumed over 1–2 h the evening prior to colonoscopy. Most patients (84%) found the FPK #3 easy or tolerable compared to only 33% receiving PEG (p < 0.001). Over 40% could not complete the PEG. There was no detectable difference in the efficacy between the two preparations (p = 0.74). Comparison of biochemical and hemodynamic values obtained before and after colonic cleansing did not reveal any significant differences apart from hyperphosphatemia in a few patients (16%) receiving FPK #3 and minor changes in blood urea nitrogen and chloride. These findings suggest that FPK #3 is better tolerated and as safe as PEG but does not provide more efficacious cleansing of the colon.

Isotretinoin-associated proctosigmoiditis

A 17-yr-old boy developed acute proctosigmoiditis after the institution of isotretinoin for the treatment of cystic acne vulgaris. Painless diarrhea, accompanied by mucus and eventually blood, began within days of commencing treatment and persisted while the drug was administered. At sigmoidoscopy patchy mucosal inflammation associated with numerous discrete aphthous ulcers was seen, apparently restricted to the rectosigmoid. Histologic examination of the affected mucosa revealed an acute focal superficial inflammatory infiltrate. Withdrawal of the drug resulted in prompt resolution of symptoms and a reduction in the severity of the inflammation. Rechallenge with isotretinoin induced a second, almost identical, attack of proctosigmoiditis. Withdrawal was again followed by disappearance of symptoms, and a subsequent sigmoidoscopy and mucosal biopsy were normal. The patient has remained clinically well for 16 mo after his initial presentation. Although the pathogenesis of the colonic mucosal inflammation remains unknown, the relationship of the bouts of proctosigmoiditis to the administration of isotretinoin strongly suggests that the drug was directly responsible.

The Probiotic VSL#3 Has Anti-inflammatory Effects and Could Reduce Endoscopic Recurrence After Surgery for Crohn's Disease

BACKGROUND & AIMS Probiotic formulations of single species of bacteria have not been effective in preventing the recurrence of Crohns disease after surgery. We investigated the ability of VSL#3, a mixture of 8 different bacterial probiotic species, to prevent Crohns disease recurrence after surgery in a multicenter, randomized, double-blind, placebo-controlled trial. METHODS Within 30 days of ileocolonic resection and re-anastomosis, patients with Crohns disease were randomly assigned to groups given 1 sachet of VSL#3 (900 billion viable bacteria, comprising 4 strains of Lactobacillus, 3 strains of Bifidobacterium, and 1 strain of Streptococcus salivarius subspecies thermophilus) (n = 59) or matching placebo (n = 60). Colonoscopy was performed at days 90 and 365 to evaluate the neoterminal ileum for disease recurrence and obtain mucosal biopsies for cytokine analysis. Patients from both groups with either no or mild endoscopic recurrence at day 90 received VSL#3 until day 365. The primary outcome was the proportion of patients with severe endoscopic recurrence at day 90. RESULTS At day 90, the proportion of patients with severe endoscopic lesions did not differ significantly between VSL#3 (9.3%) and placebo (15.7%, P = .19). The proportions of patients with non-severe lesions at day 90 who had severe endoscopic recurrence at day 365 were 10.0% in the early VSL#3 group (given VSL#3 for the entire 365 days) and 26.7% in the late VSL#3 group (given VSL#3 from days 90 through 365) (P = .09). Aggregate rates of severe recurrence (on days 90 and 365) were not statistically different, 20.5% of subjects in the early VSL#3 group and 42.1% in the late VSL#3 group. Patients receiving VSL#3 had reduced mucosal inflammatory cytokine levels compared with placebo at day 90 (P < .05). Crohns disease activity index and inflammatory bowel disease quality of life scores were similar in the 2 groups. CONCLUSIONS There were no statistical differences in endoscopic recurrence rates at day 90 between patients who received VSL#3 and patients who received placebo. Lower mucosal levels of inflammatory cytokines and a lower rate of recurrence among patients who received early VSL#3 (for the entire 365 days) indicate that this probiotic should be further investigated for prevention of Crohns disease recurrence. Clinical trials.gov number: NCT00175292.

Combined Low-Volume Polyethylene Glycol Solution Plus Stimulant Laxatives versus Standard-Volume Polyethylene Glycol Solution: A Prospective, Randomized Study of Colon Cleansing before Colonoscopy

INTRODUCTION The effectiveness of polyethylene glycol solutions (PEG) for colon cleansing is often limited by the inability of patients to drink adequate portions of the 4 L solution. The aim of the present study was to determine whether a reduced volume of PEG combined with stimulant laxatives would be better tolerated and as or more effective than the standard dose. METHODS Patients undergoing outpatient colonoscopy were randomly assigned to receive either low-volume PEG plus sennosides (120 mg oral sennosides syrup followed by 2 L PEG) or the standard volume preparation (4 L PEG). The subjects rated the tolerability of the preparations and their symptoms. Colonoscopists were blind to the colonic cleansing preparation and graded the cleansing efficacy using a validated tool (the Ottawa scale). RESULTS The low-volume PEG plus sennosides preparation was significantly better tolerated than the standard large volume PEG (P<0.001) but was less efficacious (P=0.03). Thirty-eight per cent of patients in the large volume PEG group were unable to finish the preparation, compared with only 6% in the reduced volume group. There were no adverse events reported. CONCLUSIONS Although the low-volume PEG plus sennosides preparation was better tolerated, it was not as effective as standard large-volume PEG. However, in view of the significant difference in tolerance, further research investigating possible improvements in the reduced-volume regimen seems warranted.

Indium-111-labeled autologous leukocyte imaging and fecal excretion. Comparison with conventional methods of assessment of inflammatory bowel disease.

This study was designed to evaluate the role of111In-labeled leukocyte imaging and fecal excretion in the assessment of inflammatory bowel disease. We compared these tests to various indices of disease activity in Crohns disease, to Trueloves grading in ulcerative colitis, and to endoscopy, x-ray, and pathology in both diseases. Eleven controls, 16 patients with Crohns disease, 13 with ulcerative colitis, and 3 with other types of acute bowel inflammation were studied (positive controls). Indium scanning was performed at 1,4, and 24 hr. Fourteen of 16 patients with active Crohns disease had positive scans but in only five was localization accurate. One patient had inactive ulcerative colitis, and the scan was negative. Of 12 patients with active ulcerative colitis, 10 had positive scans but disease localization was accurate in only four. Disease extent was correctly defined in 1 of the 3 Positive Controls. There was no significant difference in the accuracy of scanning at 1,4 or 24 hr.111In fecal excretion was significantly higher in patients with inflammatory bowel disease than in controls, and there was correlation between111In fecal excretion and most of the indices of disease activity in Crohns disease. In ulcerative colitis,111In fecal excretion did not correlate with Trueloves grading but reflected colonoscopic assessment of severity. In conclusion,111In-labeled leukocyte scanning lacks sensitivity with respect to disease extent, but fecal excretion of111In correlates well with disease severity as determined by other methods.

Changes in Renal Function Following Administration of Oral Sodium Phosphate or Polyethylene Glycol for Colon Cleansing before Colonoscopy

Changes in renal function were compared in patients receiving oral sodium phosphate (NaP) for colon cleansing and those receiving large-volume polyethylene glycol (PEG) solution to determine whether oral NaP resulted in frequent renal damage that had gone clinically undetected. From 1995 to 2004, a cohort of consecutive patients who had serum creatinine (Cr) drawn immediately before colonoscopy and again after subsequent procedures three months to nine years later (almost 80% of patients between the first and fifth year) were identified. Chronic renal failure (CRF) was defined as an abnormal Cr at repeat measurement or an abnormal Cr clearance as estimated by the Cockroft-Gault equation at the time of repeat Cr measurement. Medications and medical comorbid conditions were recorded. Seven hundred sixty-seven patients (51% female and 49% male; 81% oral NaP and 19% PEG) with normal baseline Cr levels were identified through the endoscopy unit database at the Hotel Dieu Hospital, Queens University (Kingston, Ontario). Of these, 55 (7%) developed CRF. Forty-two (6.8%) patients receiving oral NaP developed renal failure compared with 13 patients (8.7%) receiving PEG (Fishers exact test; P=0.382), but the magnitude of CRF was small in each group (Cr level lower than 160 mumol/L). Using logistic regression analysis with the choice of preparation, medications and medical comorbid conditions as independent variables, only age and blood pressure were predictive of the development of renal failure (P=0.014 and P=0.001, respectively). Baseline Cr clearance was similar in both the NaP and PEG groups and the absolute difference after colonoscopy did not differ. The present study concluded that the ingestion of oral NaP for colon cleansing before colonoscopy did not result in frequent renal damage that went clinically undetected.