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Chronic rectal bleeding after high-dose conformal treatment of prostate cancer warrants modification of existing morbidity scales.

PURPOSE: Serious late morbidity (Grade 3/4) from the conformal treatment of prostate cancer has been reported in <1% to 6% of patients based on existing late gastrointestinal (GI) morbidity scales. None of the existing morbidity scales include our most frequently observed late GI complication, which is chronic rectal bleeding requiring multiple fulgerations. This communication documents the frequency of rectal bleeding requiring multiple fulgerations and illustrates the variation in reported late serious GI complication rates by the selection of morbidity scale. METHODS AND MATERIALS: Between May 1989 and December 1993, 352 patients with T1-T3 nonmetastatic prostate cancers were treated with our four-field conformal technique without special rectal blocking. This technique includes a 1-cm margin from the clinical target volume (CTV) to the planning target volume (PTV) in all directions. The median follow-up for these patients was 36 months (range 2-76), and the median center of prostate dose was 74 Gy (range 63-81). Three morbidity scales are assessed: the Radiation Therapy Oncology Group (RTOG), the Late Effects Normal Tissue Task Force (LENT), and our modification of the LENT (FC-LENT). This modification registers chronic rectal bleeding requiring at least one blood transfusion and/or more than two coagulations as a Grade 3 event. Estimates for Grade 3/4 late GI complication rates were determined using Kaplan-Meier methodology. The duration of severe symptoms with chronic rectal bleeding is measured from the first to the last transrectal coagulation. Latency is measured from the end of radiotherapy to surgery, first blood transfusion, or third coagulation procedure. RESULTS: Sixteen patients developed Grade 3/4 complications by one of the three morbidity scales. Two patients required surgery (colostomy or sigmoid resection), three required multiple blood transfusions, two required one or two blood transfusions, and nine required at least three coagulations. The median duration of bleeding for those patients requiring multiple procedures was 7 months (range 3-33) and the median latency was 22 months (range 9-40). The 5-year actuarial rate of Grade 3/4 complications by each scale are: RTOG 0.7%, LENT 2%, and FC-LENT 6%. The rate of chronic rectal bleeding increases with increasing dose and is low in patients treated with conventional techniques owing to lower doses. CONCLUSION: Chronic rectal bleeding requiring any blood transfusion(s) or multiple coagulation procedures is our most frequently observed complication. This complication appears late in follow-up and is present for a long duration. We believe this justifies the inclusion of chronic rectal bleeding requiring multiple coagulation procedures as a Grade 3 event in future morbidity scales. Our data illustrate that published Grade 3/4 morbidity rates are highly dependent on the morbidity scale selected, as our data show 0.7% RTOG, 2% LENT, and 6% FC-LENT. Obviously, a uniform scale is required that includes the newly recognized serious late effects associated with the conformal treatment of prostate cancer.

Aged↗

Absent correlation between vaginal bleeding and oestradiol levels or endometrial morphology during tibolone use in early postmenopausal women.

OBJECTIVE: To investigate a potential correlation between vaginal bleeding and oestradiol (E2) levels/endometrial morphology in early postmenopausal women using tibolone (Livial(R)). METHODS: A 2-year randomised placebo-controlled study of 94 healthy women, 1-3 years after spontaneous menopause, receiving either placebo (n=23), 1.25 mg/day (n=36) or 2.5 mg/day (n=35) tibolone. Episodes of vaginal bleeding throughout the 2-year study period were recorded. Age, age of menopause, months since menopause and body mass index were recorded. Serum E2 levels were assessed at baseline and at 3-month intervals throughout the study period. In case of vaginal bleeding, endometrium morphology was assessed by Vabra Curettage. RESULTS: Fifty-one percent (n=18, P<0.05) of women in the 2.5 mg/day tibolone group and 44% (n=16, P=0.07) in the 1.25 mg/day tibolone group presented with at least one period of vaginal bleeding, compared with 22% (n=5) in the placebo group. The women who bled in the placebo group were younger (P<0.01), had menopause at an earlier age (P<0.05), had a shorter duration since menopause (P<0.05) and had a higher median E2 serum level prior to bleeding (P<0.05). In contrast, in both tibolone groups, no determinants could be found for the vaginal bleeding. Ninety percent of the first bleedings occurred within 9 months after starting the treatment. At Vabra endometrium sampling, there was no evidence of endometrial stimulation. CONCLUSIONS: In the present study, early postmenopausal women using 1.25 or 2.5 mg/day tibolone are 2-2.5 times more likely to present with vaginal bleeding compared with placebo (P<0.05) without evidence of higher serum E2 levels or endometrial stimulation.

Bone Density↗

Helicobacter pylori infection in upper gastrointestinal bleeding in patients with hereditary hemorrhagic disorders.

BACKGROUND: In patients with hereditary bleeding disorders, upper gastrointestinal bleeding presents a life-threatening complication, while the role of Helicobacter pylori (H. pylori) infection in this group of patients has not been fully clarified in the literature. The aim of the present study was to evaluate the role of H. pylori infection and of dental status in upper gastrointestinal bleeding in patients with hereditary hemorrhagic disorders (HHD). METHODS: Thirty-seven patients with HHD (18 patients with and 19 without a history of upper gastrointestinal bleeding) and 26 control patients without HHD, who were admitted to our hospital for elective gastroscopy due to dyspeptic symptoms, were included in the study. Endoscopy was performed on all patients with gastrointestinal bleeding and on controls. ELISA was used to detect IgG, anti-CagA, and IgA antibodies to H. pylori in the serum and saliva of patients and controls. Moreover, dental status was examined using the decayed/missing/filled teeth index (DMFT) in all subjects. The chi(2)-test was used for statistical analysis. RESULTS: Some 64.8% of the patients and 65.4% of the controls had H. pylori IgG antibodies in serum (P>0.1, NS) while 54.05% of the patients and 34.6% of controls were anti-CagA-positive in serum (P=NS). However, 83 and 26.3% of the HHD patients with and without gastrointestinal bleeding, respectively, were serum anti-CagA-positive (P<0.01) while 72 and 58%, respectively, were serum IgG-positive (P=NS). H. pylori antibodies in saliva and the DMFT calculated index did not differ between the two subgroups. Subsequently, all serum anti-CagA-positive HHD patients received 1-week of triple H. pylori eradication therapy with omeprazole, clarithromycin, and amoxicillin orally. During a 2-year follow-up, none of these patients reported upper gastrointestinal bleeding. CONCLUSIONS: Although no statistically significant difference in H. pylori infection was found between HHD and controls, the CagA strain appeared more frequently in those HHD patients with a history of upper gastrointestinal bleeding. Given our results and the limited data available in the literature, we would recommend anti-CagA screening and therapy to all patients with HHD. However, further studies with a longer follow-up and a greater number of patients are necessary.

Journal Article↗

Contribution of intraoperative enteroscopy in the management of obscure gastrointestinal bleeding.

Obscure gastrointestinal bleeding remains a significant diagnostic challenge. Our aims were (1) to determine the efficacy of intraoperative enteroscopy (IOE) in identifying lesions responsible for obscure gastrointestinal bleeding and (2) to determine the outcome of patients after treatment of these lesions. We retrospectively reviewed all patients who underwent IOE for obscure gastrointestinal bleeding from 1992 to 1998. Patients were divided into those with overt and those with occult gastrointestinal bleeding. Follow-up was complete in 67 patients (96%), with a median of 32 months (range 1 to 91 months). Seventy patients (52 overt and 18 occult) underwent IOE after extensive preoperative evaluation. Median duration of bleeding was 12 months, requiring a median of 14 blood transfusions. Risk factors for bleeding were identified in 46 patients (61%). A lesion was identified and treated in 52 patients (74%)-39 in the overt group and 13 in the occult group. Lesions identified were vascular (54%), ulcerations (31%), tumors (11%), and small bowel diverticula (4%). Overall, 35 patients (52%) were found to have one or more lesions at IOE that were treated surgically and had no further bleeding. IOE, through a mid-small bowel enterotomy, has low morbidity and is effective in that it identified a treatable lesion in 74% of patients, which led to cure of bleeding in 52%.

Adolescent↗

Comparison of endoscopic variceal ligation and nadolol plus isosorbide-5-mononitrate in the prevention of first variceal bleeding in cirrhotic patients.

BACKGROUND: Both drug therapy and banding ligation are widely used in the prevention of first variceal bleeding. This study compared the efficacy and safety of band ligation vs. combination of beta-blocker and nitrate for the prevention of first bleeding in patients with cirrhosis and high-risk esophageal varices. METHODS: A total of 61 patients with cirrhosis with moderate or severe esophageal varices associated with red color signs but without history of variceal bleeding were randomized to band ligation (30 patients) or treatment with nadolol plus isosorbide-5-mononitrate (ISMN) (31 patients). In the ligation group, multiband ligator with 4 elastic bands was applied during each session. Ligation was repeated at intervals of 4 weeks until variceal obliteration was achieved. In the combination group, the dose of nadolol was sufficient to reduce the pulse rate by 25%. ISMN 1 tablet 20 mg qd or bid was administered. RESULTS: Both groups were similar in baseline characteristics. In the ligation group, variceal obliteration was achieved in 24 patients (80%), at a mean of 3.2 +/- 0.9 ligation sessions and 11.7 +/- 3.2 elastic bands. In the combination group, the mean daily doses of nadolol and ISMN administered were 40 +/- 14 mg and 40 +/- 12 mg, respectively. During a median follow-up of approximately 23 months, 5 patients (17%) in the ligation group and 8 patients (26%) in the combination group had upper-gastrointestinal bleeding (p = 0.53). Esophageal variceal bleeding occurred in 3 patients (10%) in the ligation group and 6 (19%) in the combination group (p = 0.42). By multivariate Cox analysis, presence of ascites was the only factor predictive of variceal bleeding. Minor complications were noted in 5 patients (17%) in the ligation group and 3 (10%) in the combination group (p = 0.47). Eight patients in the ligation group and 6 in the combination group died (p = 0.49). One (3%) patient in the ligation group and 3 (10%) in the combination group died of uncontrollable variceal bleeding. CONCLUSION: Our preliminary results suggest that endoscopic variceal ligation is similar to the combination of nadolol plus ISMN with regard to effectiveness and safety in the prevention of first variceal bleeding in patients with cirrhosis.

Adult↗

Strategies to reduce perioperative blood loss related to non-surgical bleeding.

The treatment of critically ill patients has advanced markedly over the last decade. However, non-surgical bleeding of a diffuse nature from numerous tiny capillaries still remains a challenge. Once initiated, this type of bleeding may be troublesome and a vicious circle develops since it is not a single vessel contributing to this blood loss. The description 'non-surgical blood loss' is often given to this. This review describes a step-by-step approach for the treatment of non-surgical bleeding and includes various measures, such as desmopressin, blood components, antifibrinolytics, antithrombin III, prothrombin complex concentrates and factor XIII. While most non-surgical bleedings can be managed using the approach described here, a number of patients still continue to bleed. In these cases, the surgeon should re-evaluate the bleeding in terms of its surgical origin. If this can positively be excluded and if all of measures described fail to reduce or stop the bleeding, further treatment of such uncontrolled bleeding remains symptomatic.

Blood Coagulation Factors↗

Major bleeding rates after prophylaxis against venous thromboembolism: systematic review, meta-analysis, and cost implications.

OBJECTIVES: The frequency and consequences of major bleeding associated with anticoagulant prophylaxis for prevention of venous thromboembolism is examined. METHODS: We conducted a systematic review and meta-analysis of controlled trials that reported rates of major bleeding after pharmaceutical thromboprophylaxis in patients undergoing major orthopedic surgery. Thromboprophylactic agents were divided into four groups: warfarin/other coumarin derivatives (WARF), unfractionated heparin (UFH), low molecular weight heparin (LMWH), and pentasaccharide (PS). Meta-analysis was conducted comparing LMWH with each of WARF, UFH, and PS. The frequency of re-operation due to major bleeding was reviewed and combined with published costs to estimate the mean cost of managing major bleeding events in these patients. RESULTS: Twenty-one studies including 20,523 patients met inclusion criteria for the meta-analysis. No evidence of significant between-trial heterogeneity in risk ratios was found. Combined (fixed effects) relative risks (RR) of major bleeding compared with LMWH were WARF--RR 0.59 (95 percent confidence interval [CI], 0.44-0.80); UFH--RR 1.52 (95 percent CI, 1.04-2.23); PS--RR 1.52 (95 percent CI, 1.11-2.09). Seventy-one studies including 32,433 patients were included in the review of consequences of major bleeding. We estimated that the average cost of major bleeding is 113 dollars per patient receiving thromboprophylaxis. CONCLUSIONS: LMWH results in fewer major bleeding episodes than UFH and PS but more than WARF. These events are costly and clinically important.

Anticoagulants↗

Bleeding Complications and INR Control of Combined Warfarin and Low-Dose Aspirin Therapy in Patients with Unstable Angina and Non-Q-Wave Myocardial Infarction.

The purpose of this study was to compare bleeding complications in patients with non-Q-wave myocardial infarction and unstable angina receiving combination therapy with aspirin plus warfarin versus aspirin alone. A post-hoc analysis was performed on patients enrolled in the Antithrombotic Therapy in Acute Coronary Syndrome (ACTACS) study, which was a prospective, randomized, multicenter trial of antithrombotic therapy in unstable angina or non-Q-wave myocardial infarction. A total of 358 patients admitted within 48 hours of chest pain were randomized to antithrombotic therapy with either (1) aspirin alone or (2) aspirin (162.5 mg) plus heparin followed by aspirin plus warfarin, and were prospectively followed up for 12 weeks. Major and minor bleeding episodes, hemoglobin levels, and prothrombin times or INR levels were prospectively recorded. Major bleeding episodes were subclassified as relating to CABG/PTCA or not. The rate of major bleeding complications not associated with CABG or PTCA was 2.0%, and did not differ between therapy assignments. Among 55 patients undergoing CABG, 29 (53%) required transfusion of two or more units of blood. Minor bleeding was also infrequent (2.8%). All patients with minor bleeding had a full clinical recovery, and only one patient with a major bleed resulted in minor disability. Warfarin was well managed, with 50% of INRs falling between 1.9 and 2.7. Combination therapy with low-dose aspirin and warfarin (INR mean 2.5) produces an insignificant rise in the incidence of major and minor bleeding. These events are infrequent and do not usually result in major disability. The effect of longer duration combination therapy remains to be determined.

Journal Article↗

Successful surgery using recombinant factor VIIa for recurrent, idiopathic nonulcer duodenal bleeding in a patient with Glanzmann's thrombasthenia.

A 68-year-old man with Glanzmann's thrombasthenia suffered from recurrent cryptogenic bleeding originating in the upper duodenal flexure. Extensive endoscopic procedures and medical treatments were unsuccessful and proximal duodenectomy was proposed. In preceding years platelet transfusions had often had a suboptimal result and were complicated by allergic reactions. Surgery was carried out while he was being treated with recombinant Factor VIIa. Neither major blood loss nor other complications occurred. Histological examination of the bleeding site failed to show abnormalities and the nature of this patient's bleeding problem remained unexplained. Glanzmann's thrombasthenia is a rare autosomal recessive disorder of platelet aggregation characterized by a lifelong bleeding tendency due to abnormalities of the glycoprotein IIb-IIIa membrane complex. Common clinical manifestations include purpuric type bleeding, epistaxis, menorrhagia and gingival bleeding. Spontaneous bleeding is uncommon but posttraumatic and postoperative hemorrhage may be particularly serious. There is no specific treatment. Prophylactic and therapeutic platelet transfusions are the cornerstone of supportive treatment. In many patients the efficacy of this approach is diminished by allo-anti-platelet antibodies. We report on a patient with Glanzmann's disease with recurrent nonulcer duodenal bleeding refractory to conservative medical treatment. Despite documented suboptimal effectiveness of platelet transfusions, he underwent successful surgery with administration of recombinant factor VIIa (rFVIIa).

Aged↗

Association between smoking, betel chewing and gingival bleeding in rural Sri Lanka.

OBJECTIVE: To ascertain the association between tobacco use and gingival bleeding in a rural community in Sri Lanka. MATERIAL AND METHODS: A cross-sectional field-based study was carried out in 2178 rural males aged 20-60 years, employing a multistage cluster sampling technique. The levels of plaque and gingivitis were recorded on four sites of all teeth present excluding third molars, using the plaque index (PLI) and gingival index (GI). Information pertaining to sociodemographic variables, oral hygiene practices and tobacco consumption habits was obtained from all subjects. RESULTS: One-way anova combined with the Bonferroni test disclosed that betel chewers had a significantly higher mean number of sites with gingival bleeding (22.6+/-21.8) than smokers (10.8+/-11.2) and nontobacco users (8.7+/-6.8) (p<0.0001). A higher proportion of betel chewers (55.1%) showed > or =12 bleeding sites compared to smokers (27.6%). Logistic regression analysis revealed that the association between betel chewing and gingival bleeding was positive (OR=2.41; p<0.0001) whereas that of smoking and gingival bleeding was negative (OR=0.75; p<0.05). Oral hygiene had the strongest relationship with gingival bleeding (OR=18.11). CONCLUSION: While confirming the masking effect of smoking on gingival bleeding, these findings indicate that betel chewing might significantly enhance gingival bleeding in the population studied.

Adult↗

Air pressure responses to sudden vocal tract pressure bleeds during production of stop consonants: new evidence of aeromechanical regulation.

Two studies were conducted to evaluate short-latency vocal tract air pressure responses to sudden pressure bleeds during production of voiceless bilabial stop consonants. It was hypothesized that the occurrence of respiratory reflexes would be indicated by distinct patterns of responses as a function of bleed magnitude. In Study 1, 19 adults produced syllable trains of "puh" using a mouthpiece coupled to a computer-controlled perturbator. The device randomly created bleed apertures that ranged from 0 to 40 mm2 during production of the 2nd or 4th syllable of an utterance. Although peak oral air pressure dropped in a linear manner across bleed apertures, it averaged 2 to 3 cm H2O at the largest bleed. While slope of oral pressure also decreased in a linear trend, duration of the oral pressure pulse remained relatively constant. The patterns suggest that respiratory reflexes, if present, have little effect on oral air pressure levels. In Study 2, both oral and subglottal air pressure responses were monitored in 2 adults while bleed apertures of 20 and 40 mm2 were randomly created. For 1 participant, peak oral air pressure dropped across bleed apertures, as in Study 1. Subglottal air pressure and slope, however, remained relatively stable. These patterns provide some support for the occurrence of respiratory reflexes to regulate subglottal air pressure. Overall, the studies indicate that the inherent physiologic processes of the respiratory system, which may involve reflexes, and passive aeromechanical resistance of the upper airway are capable of developing oral air pressure in the face of substantial pressure bleeds. Implications for understanding speech production and the characteristics of individuals with velopharyngeal dysfunction are discussed.

Adolescent↗

Iliopsoas haemorrhage in patients with bleeding disorders--experience from one centre.

Iliopsoas haemorrhage in patients with bleeding disorders is a potentially life-threatening condition, with significantly associated morbidity. Despite its clinical importance, little has been published on the frequency, complications or outcomes of this entity since the advent of modern therapies for haemophilia. In a retrospective review of 297 patients with bleeding disorders followed at our centre, we identified 46 episodes of iliopsoas haemorrhage in 31 patients. Patients presented primarily with thigh, hip and/or groin pain, and frequently had flexion hip contracture, femoral nerve paresthesia, and >2 g dL(-1) haemoglobin drop. The duration of symptoms prior to seeking medical attention was 3.8 +/- 4 days. Nineteen of 155 patients (12.3%) with haemophilia A had 28 episodes of iliopsoas bleed; 52.6% of these patients had severe haemophilia. Of these 19 patients with haemophilia A who had iliopsoas haemorrhage, seven (36.8%) had an inhibitor to factor VIII (FVIII), and accounted for one-half of the bleeding episodes. Nine of 66 patients (13.6%) with haemophilia B had 15 episodes of iliopsoas haemorrhage; 22.2% of these patients had severe haemophilia, including one patient with an inhibitor to FIX who had two iliopsoas bleeds. The mean duration of therapy was 18.7 +/- 11.9 days, and the duration of hospitalization was 12.3 +/- 9.1 days. The length of hospital stay was significantly longer in patients with inhibitors, when compared with patients without inhibitors (19.1 +/- 5.8 days vs. 7.6 +/- 7.8 days; P<0.0001) with higher factor consumption, although the total duration of therapy was not significantly different. Patients with inhibitors were over-represented in the cohort of haemophiliacs with iliopsoas bleed. Patients with inhibitors who had iliopsoas bleeds remained hospitalized longer, although the duration of therapy was the same as patients with no inhibitors. There was a low frequency of recurrent bleed (2.8%).

Adolescent↗

Cone and platelet analyser (CPA): a new test for the prediction of bleeding among thrombocytopenic patients.

The risk of bleeding among thrombocytopenic patients was evaluated using our new cone and platelet analyser (CPA) test. Using this test, adherence of platelets was quantitated on extracellular matrix and expressed as percent of surface coverage (SC) and the average size (AS) of aggregates. 42 thrombocytopenic patients with ITP (n=23), post chemotherapy (n= 12) and others (n= 7) were tested over a total of 82 visits. On each visit, complete blood count and CPA tests were performed and patients were evaluated for evidence of bleeding (found in 40 visits). Bleeding patients had significantly lower platelet counts (27.4 +/- 22.0 v 47.1 +/- 21.0 x 10(9)/l), lower haematocrit values (30.2 +/- 8.1 v 35.2 +/- 6.6%), lower MPV (6.83 +/-1.89 v 8.98 +/- 1.13 fl), and lower SC (4.87 +/- 3.95 v 10.33 +/-5.48%) and AS (33.99 +/- 14.94 v 52.9 +/- 24.34 microm2). Univariate analysis yielded platelet count < or =20.0 x 10(9)/l, MPV < or =8 fl, haematocrit <35%, SC <5%, AS< or =40 microm2 as significantly associated with bleeding, whereas only MPV and SC were associated with bleeding (OR 6.95, CI 2.25-21.46 and OR 4.27, CI 1.29-14.16, respectively) by multivariate analysis. When taken together, 21/22 of patients (95%) with both low SC (<5%) and low MPV (<8.0 fl) had bleeding symptoms, whereas only 9/43 (21%) patients with both these parameters above these values experienced bleeding symptoms. We conclude that the CPA test and the parameter SC (<5%) together with MPV (< or =8 fl) might be used as independent predictors of bleeding in the management of thrombocytopenic patients.

Adolescent↗

Comparison of the efficacy of octreotide, vasopressin, and omeprazole in the control of acute bleeding in patients with portal hypertensive gastropathy: a controlled study.

BACKGROUND: Portal hypertensive gastropathy is an important complication of liver cirrhosis and it contributes to acute gastric bleeding. Effective management of this condition remains a clinical challenge. We assessed and compared the efficacy of octreotide, vasopressin, and omeprazole in the treatment of acute bleeding in patients with portal hypertensive gastropathy. METHODS: Sixty-eight patients with portal hypertensive gastropathy were randomized into Octreotide, Vasopressin, and Omeprazole groups. Bleeding was monitored by observing the contents of the nasogastric tube. Blood transfusion requirements and side-effects of drugs were recorded. Repeat endoscopies were scheduled 2 weeks after treatment. RESULTS: Complete bleeding control after 48 h of drug infusion was achieved in all patients receiving octreotide (100%), 14/22 patients receiving vasopressin (64%), and 13/22 patients receiving Omeprazole (59%). Octreotide required much less time and significantly fewer blood transfusions to control bleeding. Patients receiving vasopressin experienced more side-effects than those receiving octreotide and omeprazole. In the 17 patients whose bleeding was not controlled within 48 h by either vasopressin or omeprazole, complete bleeding control was achieved by combined use of these two agents. Follow-up endoscopy showed dramatic improvement in gastric mucosal erosions, superficial ulceration and erythema. CONCLUSIONS: Octreotide appeared to be more effective in controlling acute bleeding in patients with hypertensive gastropathy, with significantly rapid action, smaller transfusion requirements, and minor side-effects. Simultaneous administration of vasopressin and omeprazole appeared to have additive effects.

Adult↗

Investigating chronic, bright red, rectal bleeding.

BACKGROUND: Chronic, bright red, rectal bleeding is a common symptom in our community and the aetiology is frequently benign anal disease. The aim of the present study was to determine the efficacy of performing a flexible sigmoidoscopy on patients with chronic, bright red, rectal bleeding who are at low risk for colorectal neoplasia and who, on rigid sigmoidoscopy, are found to have an identifiable anal cause (e.g. haemorrhoids, fissure) for their bleeding. METHODS: A prospective study was conducted on patients presenting with chronic, bright red, rectal bleeding. Patients were considered at low risk for colorectal neoplasia if they fulfilled the following criteria: (i) less than 55 years of age; (ii) no past or family history of colorectal neoplasia or inflammatory bowel disease; (iii) no symptoms of altered bowel habit or abdominal pain; and (iv) a source of bleeding identified (e.g. haemorrhoids, fissure) on rigid sigmoidoscopy. All patients underwent a flexible sigmoidoscopy. RESULTS: Eighty-two patients were entered into the trial, mean age 39 +/- 9 years (range: 22-55 years), and the ratio of men:women was 1.8:1. The anal cause of bleeding was haemorrhoids in 96%, and anal fissure in 4%. At flexible sigmoidoscopy, five patients were found to have adenomatous polyps. Rigid sigmoidoscopy missed diminutive neoplastic lesions in 6% of patients. CONCLUSIONS: Flexible sigmoidoscopy results in a low yield of colorectal neoplasia in patients presenting with chronic, bright red, rectal bleeding who are at low risk for colorectal neoplasia and who have an identifiable anal cause for their bleeding.

Adenomatous Polyps↗

Primary prophylaxis of variceal bleeding in cirrhosis: a cost-effectiveness analysis.

BACKGROUND & AIMS: Prophylaxis against the first variceal bleeding has been proposed to reduce morbidity and mortality in cirrhotic patients. No previous information is available regarding the cost-effectiveness of prophylaxis. The aim of this study was to compare the cost-effectiveness of variceal bleeding prophylaxis with propranolol, sclerotherapy, and shunt surgery in cirrhotic patients stratified by bleeding risk. METHODS: A hypothetical cohort was stratified according to bleeding risk. The natural history of cirrhosis with esophageal varices was simulated using a Markov model. Transitional probabilities extracted from published studies and costs were obtained from our institution's billing department. Sensitivity analyses were performed for important variables. RESULTS: Propranolol results in cost savings ranging between $450 and $14,600 over a 5-year period. The extent of cost savings depended on the individual patient's bleeding risk. In addition, propranolol increased the quality-adjusted life expectancy by 0.1-0.4 years. Sclerotherapy was significantly less cost-effective than propranolol and had no advantage on quality of life. Shunt surgery was effective therapy for prevention of bleeding but decreased life expectancy and quality of life in some risk groups and was not cost-effective. CONCLUSIONS: Propranolol is the only cost-effective form of prophylactic therapy for preventing initial variceal bleeding in cirrhosis regardless of bleeding risk.

Cost-Benefit Analysis↗

Evaluation of a new endoscopic index to predict first bleeding from the upper gastrointestinal tract in patients with cirrhosis.

The aim of this study was to prospectively evaluate the usefulness of the Italian Liver Cirrhosis Project (ILCP) classification of esophageal varices, together with the gastric features of portal hypertension, in predicting the first upper gastrointestinal bleeding in cirrhosis. The efficiency of these endoscopic parameters in predicting bleeding was also compared with the efficiency of the North Italian Endoscopic Club (NIEC) index. Three hundred forty-four cirrhotic patients with esophageal varices but without any previous bleeding were enrolled in the study. The following endoscopic parameters of esophageal varices were recorded: location, size, occupancy, blue tone, and red color signs. Gastric varices were graded as absent or present, while congestive gastropathy was considered as absent, mild to moderate, or severe. All patients were followed until the first upper gastrointestinal bleeding and/or death, or for at least 24 months. No patient received any treatment to prevent bleeding. Sixty-five patients bled from the upper gastrointestinal tract during the study. Univariate analysis showed that all endoscopic parameters were predictors of bleeding. According to multivariate analysis (Cox's model), size, gastric varices and congestive gastropathy were the only independent predictors of bleeding, and the following prognostic index (PI) was developed: PI = (size x 0.0395) + (congestive gastropathy x 0.878) + (gastric varices x 0.705). This index, which was validated using a split-sample technique, and which appears to be superior to the NIEC index in predicting bleeding, may be useful in decision making for primary prophylaxis.

Adult↗

Multicenter randomized controlled trial of terlipressin versus sclerotherapy in the treatment of acute variceal bleeding: the TEST study.

Failure to control bleeding and early rebleeding account for the high mortality associated with variceal hemorrhage in cirrhosis. We compared endoscopic sclerotherapy to terlipressin, a drug that effectively controls acute bleeding while reducing in-hospital mortality. This multicenter randomized controlled trial included 219 cirrhotic patients admitted for endoscopy-proven acute variceal bleeding and randomized to receive repeated injections of terlipressin during 6 days (n = 105) or emergency sclerotherapy (n = 114). Success was defined as obtaining control of bleeding (24-hour bleeding-free period during the first 48 hours) and lack of early rebleeding (any further bleeding from initial control to 5 days later) and survival during the study. Both groups were similar at inclusion. Failure rate for terlipressin was 33% and 32% for sclerotherapy (not significant [NS]). Early rebleeding was responsible for 43% and 44% of failures, respectively. This high efficacy was observed in both Child-Pugh class A + B and Child-Pugh class C patients. Both treatments were similar regarding transfusion requirements, in-hospital stay, and 6-week mortality (26 vs. 19 patients). Side effects appeared in 20% of patients receiving terlipressin and in 30% of those on sclerotherapy (P =.06); being serious in 4% and 7%, respectively (NS). In conclusion, terlipressin and sclerotherapy are equally highly effective therapies achieving the initial control of variceal bleeding and preventing early rebleeding. Both treatments are safe, but terlipressin is better tolerated. Therefore, terlipressin may represent a first-line treatment in acute variceal bleeding until the administration of elective therapy, especially in hospitals where a skilled endoscopist is not available 24 hours a day.

Acute Disease↗