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PubMed1998

Unexpected vaginal bleeding and associated gynecologic care in postmenopausal women using hormone replacement therapy: comparison of cyclic versus continuous combined schedules.

OBJECTIVE: To measure gynecologic resources required to care for women who have unexpected vaginal bleeding while using hormone replacement therapy (HRT). DESIGN: A retrospective cohort study based on review of medical records. SETTING: A large health maintenance organization. PATIENT(S): We studied 284 women using continuous combined HRT and 306 women receiving cyclic HRT. MAIN OUTCOME MEASURE(S): We noted episodes of unexpected vaginal bleeding and associated clinic visits and gynecologic procedures recorded during a mean follow-up period of 2 years. RESULT(S): Among women using cyclic HRT for the first time, 38.3% had > or = 1 visit for unexpected bleeding and 12.3% had > or = 1 endometrial biopsy. Among women starting continuous combined HRT, 41.6% had > or = 1 visit for unexpected bleeding and 20.1% had > or = 1 endometrial biopsy. After adjusting for potential confounding variables, we found that recipients of cyclic and continuous combined HRT had similar risks of unexpected bleeding and endometrial biopsy. However, among women continuing HRT for >2 years, those using the continuous combined regimen had somewhat lower rates of unexpected bleeding (22.3 events per 100 patient-years) and endometrial biopsy (10.3 events per 100 patient-years) than those using the cyclic regimen (37.8 episodes of unexpected bleeding per 100 patient-years and 13.9 endometrial biopsies per 100 patient-years). CONCLUSION(S): Unexpected vaginal bleeding and the gynecologic resources required to manage it decreased after 2 years in women using continuous combined HRT but did not decline among those using cyclic HRT.

Aged↗
PubMed2003

Emergency sclerotherapy versus vasoactive drugs for variceal bleeding in cirrhosis: a Cochrane meta-analysis.

BACKGROUND & AIMS: Emergency sclerotherapy is used as a first-line therapy for variceal bleeding in cirrhosis, although pharmacologic treatment stops bleeding in most patients. We performed a meta-analysis comparing emergency sclerotherapy with pharmacologic treatment. METHODS: MEDLINE (1968-2002), EMBASE (1986-2002), and the Cochrane Library (2002;4) were searched to retrieve randomized controlled trials comparing sclerotherapy with vasopressin (+/- nitroglycerin), terlipressin, somatostatin, or octreotide for variceal bleeding in cirrhosis. Outcome measures were failure to control bleeding, rebleeding, blood transfusions, adverse events, and mortality. RESULTS: Fifteen trials were identified. Sclerotherapy was not superior to terlipressin, somatostatin, or octreotide for any outcome and to vasopressin for rebleeding, blood transfusions, death, and adverse events; it was superior to vasopressin for the control of bleeding in a single trial flawed by a potential detection bias. Sclerotherapy was associated with significantly more adverse events than somatostatin. In a predefined sensitivity analysis, combining all of the trials irrespective of the control treatment, risk differences (sclerotherapy minus control) and confidence intervals (CIs) were as follows: failure to control bleeding, -0.03 (-0.06 to 0.01); mortality, -0.035 (-0.07 to 0.008); adverse events, 0.08 (0.02 to 0.14). Mortality risk difference was -0.01 (-0.07 to 0.04) in good-quality trials and -0.08 (-0.14 to -0.02) in poor-quality trials. CONCLUSIONS: Available evidence does not support emergency sclerotherapy as the first-line treatment of variceal bleeding in cirrhosis when compared with vasoactive drugs, which control bleeding in 83% of patients. Therefore, endoscopic therapy might be added only in pharmacologic treatment failures.

Acute Disease↗
PubMed2004

Risk of colonoscopic polypectomy bleeding with anticoagulants and antiplatelet agents: analysis of 1657 cases.

BACKGROUND: Anticoagulants and antiplatelet agents commonly are used to treat patients with cardiovascular and cerebrovascular diseases. Data on the safety of the use of these drugs before colonoscopic polypectomy are scanty. METHODS: An audit was conducted for a 2-year period of consecutive patients undergoing colonoscopy and polypectomy. Patient demographics, site and size of polyps, and the use of anticoagulants and antiplatelet agents were documented from a hospital on-line database. Bleeding episodes were classified as immediate or delayed and were graded as mild, moderate, or severe. Risk factors associated with postendoscopy bleeding were analyzed by multivariate logistic regression analysis. RESULTS: A total of 5593 cases were reviewed. Polypectomy was performed in 1657 patients. There were 37 cases of polypectomy-associated bleeding (2.2%); bleeding was immediate in 32 and delayed in 5. Multivariate analysis showed that warfarin use, after adjustment for the effects of each of the other factors, was an independent risk factor for bleeding, with an odds ratio 13.37: 95% CI[4.10, 43.65]. Age; the location and size of polyp; and the use of aspirin, non-steroidal anti-inflammatory drugs, and other antiplatelet agents were not associated with a higher risk of polypectomy-associated bleeding. CONCLUSIONS: The use of antiplatelet agents during polypectomy was not associated with an increase in post-polypectomy bleeding. In contrast, treatment with warfarin should be discontinued, because this was associated with a significant increase in post-polypectomy bleeding.

Aged↗
PubMed2003

Randomized controlled trial comparing epinephrine injection plus heat probe coagulation versus epinephrine injection plus argon plasma coagulation for bleeding peptic ulcers.

BACKGROUND: Epinephrine injection with heat probe coagulation is an effective treatment for bleeding peptic ulcer. Few studies have investigated the efficacy of dual therapy with epinephrine injection plus either heat probe or argon plasma coagulation for high-risk bleeding peptic ulcers. This study compared epinephrine injection plus heat probe coagulation to epinephrine injection plus argon plasma coagulation for the treatment of high-risk bleeding peptic ulcers. METHODS: The study design was prospective, randomized, and controlled. Patients with actively bleeding peptic ulcers, ulcers with adherent clots, or ulcers with nonbleeding visible vessels were randomly assigned to epinephrine injection plus heat probe coagulation or epinephrine injection plus argon plasma coagulation. Patients with previous gastric surgery, malignant ulcers, and unidentifiable ulcers because of torrential bleeding were excluded. The primary outcome measure was recurrence of bleeding. Secondary outcome measures were initial hemostasis, endoscopic procedure duration, number of patients requiring surgery, mortality within 30 days, and ulcer status at 8 week follow-up endoscopy. RESULTS: One hundred ninety-two patients were enrolled; 7 with malignant ulcers were excluded after randomization. One hundred eighty-five cases were analyzed, 97 in the heat probe group and 88 in the argon plasma coagulation group. Patient demographics and ulcer characteristics were comparable between the groups. There was no significant difference in terms of initial hemostasis (95.9% vs. 97.7%), frequency of recurrent bleeding (21.6% vs. 17.0%), requirement for emergency surgery (9.3% vs. 4.5%), mean number of units of blood transfused (2.4 vs. 1.7 units), mean hospital stay (8.2 vs. 7.0 days), and hospital mortality (6.2% vs. 5.7%). Sixty (61.8%) patients in the heat probe group and 52 (52.9%) in the argon plasma coagulation group underwent endoscopy at 8 weeks. There was no significant difference between these groups in the relative frequency of nonhealing ulcer at 8 weeks. CONCLUSION: Epinephrine injection plus argon plasma coagulation is as safe and effective as epinephrine injection plus heat probe coagulation in the treatment of patients with high-risk bleeding peptic ulcers.

Adult↗
PubMed2004

Can clinical features predict the likelihood of finding abnormalities when using capsule endoscopy in patients with GI bleeding of obscure origin?

BACKGROUND: Capsule endoscopy is becoming the investigation of choice for GI bleeding of obscure etiology. This study examined whether clinical or other features predict an increased likelihood of finding a lesion in patients with this type of bleeding. METHODS: Clinical and other data were collected prospectively for 92 patients undergoing capsule endoscopy for GI bleeding of obscure origin. Patients were divided into two groups: those with overt bleeding (42 patients) and those with anemia alone (50 patients). The relationship between these data and the findings at capsule endoscopy was examined. RESULTS: A definite or probable cause of bleeding was found in 60 patients (angiodysplasias 47, tumor 7, ulcer 3, gastric antral vascular ectasia 2). There was no difference between the two groups with respect to age, gender, mode of presentation, duration of bleeding, or need for transfusion. Lesions were found as often in patients who had only one preceding endoscopy and colonoscopy as in those who had multiple procedures. Colonic cleansing and cecal imaging by the capsule did not influence the result. Hospitalized patients were more likely to have an actively bleeding lesion detected. CONCLUSIONS: Capsule endoscopy is equally useful in patients with overt and occult GI bleeding of obscure origin. Capsule endoscopy should be performed early in the evaluation of these patients.

Adolescent↗
PubMed2004

A randomized study of the safety of outpatient care for patients with bleeding peptic ulcer treated by endoscopic injection.

BACKGROUND: Outpatient management is safe for patients with non-variceal upper-GI bleeding who are at low risk of recurrent bleeding and death. However, outpatient care cannot be offered to many patients because of the presence of risk factors (severe comorbid disorders, major endoscopic stigmata of bleeding, significant hemorrhage). The present study assessed the safety of outpatient management for selected high-risk patients with bleeding peptic ulcer. METHODS: Patients hospitalized with upper-GI bleeding because of peptic ulcer with a non-bleeding vessel were eligible for inclusion in the study. Inclusion criteria were the following: ulcer size less than 15 mm, absence of hypovolemia, no associated severe disease, and appropriate family support. After endoscopic therapy (injection of epinephrine and polidocanol), patients were randomized to outpatient or hospital care. Patients remained in the emergency ward for a minimum of 6 hours before discharge, during which time omeprazole was administered intravenously. Outpatients were contacted by telephone daily during the first 3 days; a 24-hour telephone hotline was provided for any queries. For both groups, outpatient visits were scheduled at 7 to 10 and 30 days after discharge. RESULTS: A total of 82 patients were included: 40 were randomized to outpatient care and 42 to hospital care. Clinical and endoscopic variables were similar in both groups. The rate of recurrent bleeding was similar in both groups (4.8% outpatient, 5% hospital). There was no morbidity or mortality in either group at 30 days. Seven patients (17%) randomized to outpatient care received blood transfusion compared with 14 (38%) in the hospital care group (p=0.06). Mean cost of care per patient was significantly lower for the outpatient vs. the hospital group (970 US dollars vs. 1595 US dollars; p < 0.001). CONCLUSIONS: Selected patients with bleeding peptic ulcer can be safely managed as outpatients after endoscopic therapy. This policy conserves health care resources without compromising standards of care.

Aged↗
PubMed2005

Post-sphincterotomy bleeding after the introduction of microprocessor-controlled electrosurgery: does the new technology make the difference?

BACKGROUND: Bleeding as a complication of endoscopic sphincterotomy is influenced by several factors. The objective of this study was to compare rates of bleeding after sphincterotomy performed with two different electrosurgical current generators (Valleylab SSE2L and ERBE ICC200). METHODS: A total of 6179 consecutive reports of ERCP were analyzed to compare the frequency of endoscopically and clinically evident bleeding after sphincterotomy when using the Valleylab SSE2L generator (from February 1994 to November 1997) and the ERBE ICC200 generator (from December 1997 to September 2000). Relevant risk factors were assessed by univariate analysis and significant predictors were included in a multiple logistic regression model. RESULTS: A total of 2711 sphincterotomies were performed in 2309 patients (1749 biliary, 962 pancreatic). Endoscopically observed bleeding occurred in 68 patients (5.5%) in the ValleyLab group and 13 (1.2%) in the ERBE group. The ValleyLab generator was independently associated with an increase in endoscopically observed bleeding (OR 4.02: 95% CI[2.13, 7.61], p <0.001). There was no significant difference in clinically evident bleeding between the two groups. CONCLUSIONS: Use of the microprocessor-controlled ERBE electrosurgical generator for endoscopic sphincterotomy was associated with a significantly lower frequency of endoscopically observed bleeding but not clinically evident bleeding.

Adult↗
PubMed2003

Endoscopic ligation of esophageal varices for prophylaxis of first bleeding in children and adolescents with portal hypertension: preliminary results of a prospective study.

BACKGROUND/PURPOSE: Endoscopic variceal ligation (EVL) is effective in controlling rebleeding from esophageal varices in children, but there is no data on the use of EVL to prevent initial bleeding. The objective of this study was to prospectively evaluate the efficacy of EVL in preventing the first hemorrhage from esophageal varices in children. METHODS: Thirty-seven children with portal hypertension (22 liver cirrhosis, 15 portal vein thrombosis), aged 4 to 17 years (M = 9.5 +/- 4.4 years) were included in the study. The criteria for inclusion were (1) no previous variceal bleeding; (2) the presence of esophageal varices classified grade II or more, and (3) their enlargement by at least I grade after 6 months of observation without endoscopic treatment or appearance of endoscopic signs of high bleeding risk. A Multi-Band Ligator was used, and 2 to 6 bands were fixed under general anesthesia during one procedure depending on the number and size of varices. Follow-up examinations were performed every 3 months, repeating the procedure if necessary. In total, 75 procedures of EVL were performed, from one to 5 in each patient RESULTS: Four patients underwent liver transplantation before eradication of varices. Two others were excluded from the observation because of lack of compliance to the protocol. Of the remaining 31 patients, eradication of varices was achieved in 28 children (90.3%) after 2.0 EVL sessions performed at 3-month intervals. The average time of follow-up after cessation of treatment is 16 months. No bleeding from varices occurred in any child during or after treatment. There were no differences in results between children with liver cirrhosis and portal vein thrombosis. Development of hypertensive gastropathy was observed in 2 children with one episode of bleeding. Recurrence of varices without bleeding occurred in 3 children after 12, 13, and 28 months from eradication. CONCLUSIONS: The study results confirmed that endoscopic variceal ligation is a safe and highly effective procedure in children with portal hypertension, regardless of its etiology. Eradication of esophageal varices was followed by 16 months free of bleeding. Prolonged observation is mandatory to conclude if preventive EVL influences the natural history of disease and diminishes the risk of first bleeding onset.

Adolescent↗
PubMed1988

Acute gastrointestinal bleeding--a common problem revisited.

Acute gastrointestinal bleeding, a common problem, becomes a serious situation in the 15% of afflicted patients in whom the bleeding does not stop spontaneously. The typical high-risk patient is elderly, has multisystem disease, has a hemorrhagic episode during hospitalization for other disorders, or is an outpatient with severe bleeding of short duration and symptoms of volume depletion. Endoscopy can be performed to identify the active site of hemorrhage and is associated with an overall diagnostic accuracy that exceeds 90% in patients with upper gastrointestinal bleeding. The rate and character of observed bleeding have substantial predictive value for continued bleeding. The mortality among high-risk patients with bleeding in either the upper or the lower gastrointestinal tract ranges from 17 to 44%. Therefore, an organized aggressive approach to management of acute gastrointestinal bleeding is necessary.

Acute Disease↗
PubMed2000

Hormone replacement therapy: effect of progestin dose and time since menopause on endometrial bleeding.

OBJECTIVE: To analyze the effects of two continuous combined hormone replacement regimens on bleeding profiles in postmenopausal women, based on progestin dose and time since the patient's last spontaneous menstrual period. METHODS: A randomized, double-masked, multicenter trial was conducted in 1724 women recruited from 99 sites. Six hundred seventy-eight women received a continuous regimen of oral conjugated equine estrogens (CEE), 0.625 mg/day, combined with medroxyprogesterone acetate (MPA), 2.5 or 5.0 mg/day, for 1 year. RESULTS: After 1 year, no bleeding was reported by over 89% of women. More women in the 5.0 mg/day MPA group than in the 2.5 mg/day MPA group reported no bleeding (93.8% versus 89.5%; P<.089). Of those women who had had their last menstrual period 3 years ago or less, a significantly higher percentage in the 5.0 mg/day MPA group (72.4%) did not experience bleeding after three cycles compared with the 2.5 mg group (59.0%; P<.001). Although the percentage of patients without bleeding was also higher in the 5.0 mg/day MPA group after six cycles and 1 year, the differences between groups were not statistically significant. Of the women who had their last menstrual period more than 3 years ago, 94.7% of those in the 5.0 mg/day MPA group and 90.7% of those in the 2.5 mg/day MPA group reported no bleeding at 1 year. CONCLUSION: A continuous combined regimen of CEE plus 5.0 mg MPA may be more suitable for women closer to the onset of menopause or for women starting therapy who are unwilling to tolerate irregular bleeding. The improved bleeding profile with CEE and 5.0 mg/day MPA is likely to enhance compliance with hormone replacement therapy.

Aged↗
PubMed1997

The duration and character of postpartum bleeding among breast-feeding women.

OBJECTIVE: To examine the postpartum bleeding experience of a cohort of breast-feeding women and to compare it with the conventional definition of lochia. METHODS: Four hundred seventy-seven experienced breast-feeding women in Manila, the Philippines, were followed prospectively from delivery and recorded vaginal bleeding in a menstrual diary. The median duration of lochia was calculated using survival analysis. In addition, all bleeding separate from lochia within the first 8 weeks postpartum was noted. RESULTS: The median duration of lochia was 27 days and did not vary by age, parity, sex or weight of the infant, breast-feeding frequency, or level of supplementation. More than one-fourth of the women experienced a bleeding episode separated from the original lochial flow by at least 4 bleeding-free days and beginning no later than postpartum day 56. Ten breast-feeding women may have had their first menstrual bleed before day 56. CONCLUSIONS: Lochia lasted substantially longer than the conventional assumption of 2 weeks. It was common for postpartum bleeding to stop and start again or to be characterized by intermittent spotting or bleeding. Return of menses is rare among fully breast-feeding women in the first 8 weeks postpartum.

Adult↗
PubMed2003

Ultrasonographic evaluation of the endometrium in postmenopausal vaginal bleeding.

Transvaginal ultrasound with SIS is a cost-minimizing screening tool for perimenopausal and postmenopausal women with vaginal bleeding. Its use decreases the need for invasive diagnostic procedures for women without abnormalities, and ultrasound increases the sensitivity of detecting abnormalities in women with pathologic conditions. Vaginal sonography is preferred over uniform biopsy of postmenopausal women with vaginal bleeding because it (1) is a less invasive procedure, (2) is generally painless, (3) has no complications, and (4) may be more sensitive for detecting carcinoma than blind biopsy. Transvaginal sonography is rarely nondiagnostic. Endometrial sampling is less successful in women with a thin endometrial stripe on ultrasound than in women with real endometrial pathologic condition. A limitation of ultrasound is that an abnormal finding is not specific: ultrasound cannot always reliably distinguish between benign proliferation, hyperplasia, polyps, and cancer. Although ultrasound may not be able to distinguish between hyperplasia and malignancy, the next step in the clinical treatment requires tissue sampling. Because of the risk of progression of complex hyperplasia to carcinoma, patients with this finding may benefit from hormonal suppression, dilatation and curettage, endometrial ablation, or hysterectomy, depending on the clinical scenario. The inability to distinguish these two entities based on ultrasound alone should not be seen as a limitation because tissue sampling is required in either case. Occasionally (in 5% to 10% of cases), a woman's endometrium cannot be identified on ultrasound, and these women also need further evaluation. Ultrasonography also may be used as a first-line investigation in other populations with abnormal uterine bleeding. In a multicenter, randomized, controlled trial of 400 women with abnormal uterine bleeding, the investigators found that transvaginal sonography combined with Pipelle endometrial biopsy and outpatient hysteroscopy was as effective as inpatient hysteroscopy and curettage. The subject, included women older than 35 years with PMB, menorrhagia, intermenstrual bleeding, postcoital bleeding, or irregular menses. Transvaginal sonography may be a cost-effective. sensitive, and well-tolerated method to evaluate most women with abnormal bleeding in combination with physical examination and endometrial biopsy and hysteroscopy us indicated. Hysteroscopy is likely to become the new gold standard in the future because of its ability to visualize directly the endometrium and perform directed biopsies as indicated. As office-based hysteroscopy becomes more practical and widespread, the technique may become more cost effective. An evaluation plan using transvaginal sonography as the initial screening evaluation followed by endometrial biopsy or, more likely, hysteroscopy is likely to become the standard of care (Fig. 12). It remains unproven whether certain patients at higher risk for carcinoma should proceed directly to invasive evaluation. Women on tamoxifen with persistent recurrent bleeding, women with significant risk factors for carcinoma, and women with life-threatening hemorrhage comprise this group. Further studies are still necessary to evaluate high-risk patients and determine whether ultrasound or biopsy is really the most cost-effective initial test.

Atrophy↗
PubMed1986

How important is rectal bleeding in the diagnosis of bowel cancer and polyps?

Overt bleeding from the anus is a common symptom of colorectal cancer but most frequently arises from a benign anal source. The aim of this study was to determine how successfully general practitioners and gastroenterologists could differentiate anal from colorectal sources of bleeding before full colonic investigation. 145 consecutive patients aged 40 years and over who had presented to a GP with rectal bleeding of less than 6 months' duration were referred to a specialist for total colonic investigation. The source of bleeding was diagnosed as colorectal cancer in 15 patients (7 stage A, 3 stage B) and polyps in 11. Of 63 patients in whom GPs predicted an anal source of bleeding only, 11 were ultimately found to be bleeding from a colonic or rectal source. The gastroenterologists (after rigid sigmoidoscopy) predicted an anal source of bleeding in 97, in 5 of whom the source was ultimately found to be colorectal. All patients aged over 40 who present with recent rectal bleeding should be referred for full colonic investigation.

Adult↗
PubMed1996

Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Italian Study on Complications of Oral Anticoagulant Therapy.

BACKGROUND: Bleeding is the most serious complication of the use of oral anticoagulation in the prevention and treatment of thromoboembolic complications. We studied the frequency of bleeding complications in outpatients treated routinely in anticoagulation clinics. METHODS: In a prospective cohort from thirty-four Italian anticoagulation clinics, 2745 consecutive patients were studied from the start of their oral anticoagulation (warfarin in 64%, acenocourmarol in the rest). The target anticoagulation-intensity was low (international normalised ratio [INR] < or = 2.8) in 71% of the patients and high (> 2.8) in the remainder. We recorded demographic details and the main indication for treatment and, every 3-4 months, INR and outcome events. Such events included all complications (bleeding, thrombosis, other), although only bleeding events are reported here, and deaths. We divided bleeding into major and minor categories. FINDINGS: 43% of the patients were women. Nearly three-fifths of the patients were aged 60-79; 8% were over 80. The main indication for treatment was venous thrombolism (33%), followed by non-ischaemic heart disease (17%). Mean follow-up was 267 days. Over 2011 patient-years of follow-up, 153 bleeding complications occurred (7.6 per 100 patient-years). 5 were fatal (all cerebral haemorrhages, 0.25 per 100 patient-years), 23 were major (1.1), and 125 were minor (6.2). The rate of events was similar between sexes, coumarin type, size of enrolling centre, and target INR. The rate was higher in older patients: 10.5 per 100 patient-years in those aged 70 or over, 6.0 in those aged under 70 (relative risk 1.75, 95% Cl 1.29-2.39, p < 0.001). The rate was also higher when the indication was peripheral and/or cerebrovascular disease than venous thromboembolism plus other indications (12.5 vs 6.0 per 100 patient-years) (1.80, 1.2-2.7, p < 0.01), and during the first 90 days of treatment compared with later (11.0 vs 6.3, 1.75, 1.27-2.44, p < 0.001). A fifth of the bleeding events occurred at low anticoagulation intensity (INR < 2, rate 7.7 per 100 patient-years of follow-up). The rates were 4.8, 9.5, 40.5, and 200 at INRs 2.0-2.9, 3-4.4, 4.5-6.9, and over 7, respectively (relative risks for INR > 4.5, 7.91, 5.44-11.5, p < 0.0001). INTERPRETATION: We saw fewer bleeding events than those recorded in other observational and experimental studies. Oral anticoagulation has become safer in recent years, especially if monitored in anticoagulation clinics. Caution is required in elderly patients and anticoagulation intensity should be closely monitored to reduce periods of overdosing.

Acenocoumarol↗
PubMed2002

Relationships between DVHs and late rectal bleeding after radiotherapy for prostate cancer: analysis of a large group of patients pooled from three institutions.

BACKGROUND: Accurate modeling of late rectal reactions needs the collection of individual 3D dose-volume data (i.e. DVH) as well as clinical information of large cohorts of patients. The possibility of collecting a large number of patients with many different dose-volume combinations is very suitable for this purpose. PURPOSE: The purpose of the study is to search for significant correlation between dose-volume histograms/dose statistics of the rectum and late rectum bleeding. MATERIALS AND METHODS: Data from three institutions for 402 patients previously treated for prostate cancer with three to four field techniques, were retrospectively pooled and were collected with a number of clinical and physical parameters, including DVHs of the rectum (including filling). Patients with large air/fecal content in the rectum during planning computerized tomography (CT) scan were excluded from the analysis (n = 74). Out of 328 patients, 229 patients received an ICRU dose between 70 and 76Gy and the current analysis is referred to this subgroup of patients (median follow up: 30 months, range: 12-85 months). Out of these 229 patients, 189 patients were treated with conformal techniques. Rectum was contoured from the anal verge up to the sigmoid flessure by one observer for each institution. Dosimetric and contouring consistencies between the three institutions were previously investigated and the impact on DVHs was found to be quite modest for the purposes of the study. Median/quartile values of all parameters were considered as cut-off values for statistical analysis. We considered as bleeders those patients who experienced grades II-III late bleeding (modified RTOG scoring scale). RESULTS: Twenty two of 229 patients experienced > or =grade II late bleeding (30 months actuarial incidence: 10.7%). Significant correlation between a number of parameters and late bleeding was found (log-rank test). With regard to DVH, all median and third quartile values for V50-V70 were found to be significantly associated with an increased risk of rectal bleeding, if excepting the median value of V70. Based on the results of univariate analysis, the patients were divided into two groups: 'high risk', with at least one value above quartiles in the range V50-V60 (V50: 70%, V55: 64%, V60: 55%); 'low risk', the remaining patients. The 30 months actuarial rates of bleeding were 19.2 and 5.9% for the 'high' and the 'low' risk group, respectively (P = 0.0003 log-rank test). A multivariate analysis (Cox regression model) including 'DVH grouping' and the main remaining variables (age, previous prostatectomy, diabetes, hypertension, adjuvant hormonal therapy, rectum volume and ICRU dose) showed that 'DVH grouping' is the most predictive parameter (P = 0.005) together with adjuvant hormonal therapy (P = 0.025) and ICRU dose (P = 0.06). CONCLUSIONS: Our data confirm the role of the rectal DVH in separating groups of patients having prostate radiotherapy in low and high risk of developing late bleeding. Based on these results, V50 below 60-65% and V60 below 50-55% seem to be the robust cut-off values to keep the risk of developing late rectal bleeding reasonably low. However, due to the 'heterogeneity' of the considered population, the results found should be applied with caution in 'more homogeneous' groups of patients. The association of adjuvant hormone deprivation seems to be associated with an increased risk of rectal toxicity; the mechanism for this effect should be a focus of further research.

Actuarial Analysis↗
PubMed1992

Potentiation of uremic bleeding by hereditary storage pool disease.

This study demonstrates that specific bleeding tests can separate the thrombocytopathy of uremia alone from the bleeding disorders caused by uremia superimposed on preexisting platelet dysfunction. The case history of a uremic patient with exaggerated bleeding tendencies is presented. The findings in this patient are compared with the clinical characteristics and platelet function studies of nine other patients with chronic renal failure. The index and other uremic patients were similar except for the clinical bleeding and results of platelet function studies. The patient's nonocclusive bleeding time and measured blood loss during bleeding time tests were increased compared with the other uremic controls. In addition, her platelet aggregation in response to collagen was lower than that of the other uremic subjects. Repeat studies following renal transplantation were consistent with hereditary storage pool disease. An underlying platelet disorder may potentiate the hemostatic defects of uremia. The diagnosis should be suspected in patients with frequent and severe bleeding manifestations. Renal transplantation led to control of clinical bleeding.

Adult↗
PubMed2003

Major bleeding complications in cardiopulmonary resuscitation: the place of thrombolytic therapy in cardiac arrest due to massive pulmonary embolism.

OBJECTIVE: Thrombolytic therapy in patients with massive pulmonary embolism (MPE) and prolonged cardiopulmonary resuscitation (CPR) is subject to debate. This study was performed to determine whether (1) thrombolytic treatment increases the risk of bleeding complications, (2) if the risk of bleeding is influenced by the duration of CPR and if (3) thrombolytic therapy improves outcome. DESIGN: Retrospective cohort study. SETTING: Emergency department of a tertiary care university hospital. PATIENTS AND METHODS: Sixty-six patients with cardiac arrest (CA) due to MPE admitted between July 1993 and December 2001. Thirty-six patients received thrombolysis (TL) and were compared with 30 patients without thrombolytic therapy. Bleeding complications were assessed by clinical evidence or autopsy. RESULTS: Major bleeding complications appear to occur more frequently in patients treated with thrombolytics (9/36 (25%) vs. 3/30 (10%)) even though the difference was statistically not significant (P=0.15). It appears that CPR duration >10 min has no adverse impact on major bleeding complications. No difference in the rate of major bleeding complications between thrombolyzed patients who had a CPR duration of </=10 or >10 min could be observed (2/8 (25%) vs. 7/28 (25%), P=0.99). In thrombolyzed patients a return of spontaneous circulation could be achieved more frequently (24/36 (67%) vs.13/30 (43%) in controls, P=0.06) and survival after 24 h was higher (19/36 (53%) vs. 7/30 (23%), P=0.01). Survival to discharge was also higher in the TL group (7/36 (19%) vs. 2/30 (7%)), but not statistically significant (P=0.15). CONCLUSION: Although severe bleeding complications tend to occur more frequently in patients undergoing TL, the benefit of this treatment might outweigh the risk of bleeding.

Adolescent↗
PubMed2004

Rectal bleeding and its management after irradiation for uterine cervical cancer.

PURPOSE: To present an evaluation of the risk factors of radiation-induced rectal bleeding and discuss its optimal management in patients with cancer of the cervix. METHODS AND MATERIALS: A total of 213 patients treated with radiotherapy (RT) alone were included. All patients underwent external beam radiotherapy with high-dose-rate brachytherapy. The rectal dose was calculated by both the International Commission on Radiation Units and Measurements (ICRU) Report 38 guidelines and the anterior rectal wall point on radiographs. Rectal bleeding was scored using the late effects normal tissue-subjective, objective, management, and analytic criteria. RESULTS: The incidence was 12.7% (27 of 213; Grade 1 in 9, Grade 2 in 16, and Grade 3 in 2). Most (92.6%) developed rectal bleeding within 2 years after RT completion (median 16 months). In univariate analysis, three significant factors were found: ICRU cumulative rectal biologically equivalent dose (CRBED) >100 Gy (19.7% vs. 4.2%), external beam RT dose to the parametrium >55 Gy (22.1% vs. 5.1%), and advanced stage (III-IV; 31.8% vs. 10.5%). In multivariate analysis, the ICRU-CRBED was the only significant factor. Six patients with Grade 1 bleeding experienced immediate relief with sucralfate enema for 1 month. For Grade 2 bleeding, sucralfate enema and/or coagulation were effective. Grade 3 bleeding lasted for 1 year despite frequent transfusions and coagulation. CONCLUSION: Grade 2 and 3 rectal bleeding occurred in 8.5% of patients. The most significant risk factor was the ICRU-CRBED. Prompt treatment with a combination of sucralfate enema and coagulation was effective in controlling Grade 1 and 2 rectal bleeding without the development of fistula or stricture.

Adult↗