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At least 19 recordsLinked to original sources

Use of sedation for routine diagnostic upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy Survey of National Endoscopy Society Members.

BACKGROUND/AIMS: Sedation rates may vary among countries, depending on patients' and endoscopists' preferences. The aim of this survey was to investigate the rate of using premedication for routine diagnostic upper gastrointestinal (UGI) endoscopy in endoscopy societies, members of the European Society of Gastrointestinal Endoscopy (ESGE). METHODS: We evaluated a multiple-choice questionnaire which was e-mailed to representatives of national endoscopy societies, which are members of the ESGE. The questionnaire had 14 items referring to endoscopy practices in each country and the representatives' endoscopy units. RESULTS: The response rate was 76% (34/45). In 47% of the countries, less than 25% of patients undergo routine diagnostic UGI endoscopy with conscious sedation. In 62% of the responders' endoscopy units, patients are not asked their preference for sedation and do not sign a consent form (59%). Common sedatives in use are midazolam (82%), diazepam (38%) or propofol (47%). Monitoring equipment is not available 'in most of the endoscopy units' in 46% (13/28) of the countries. Though they were available in 91% of the national representatives' endoscopy units, they are rarely (21%) used to monitor unsedated routine diagnostic UGI endoscopy. CONCLUSIONS: In about 50% of ESGE-related countries, less than 25% of patients are sedated for routine diagnostic UGI endoscopy. Major issues to improve include availability of monitoring equipment and the use of a consent form.

Procedural Sedation↗

The GASTER project: building a computer network in digestive endoscopy: the experience of the European Society for Gastrointestinal Endoscopy. Gastrointestinal Endoscopy Application for Standards in Telecommunication, Education and Research.

Digestive endoscopy is currently the main diagnostic procedure for investigation of the digestive tract whenever a digestive disease is suspected. From 1970 to 1985, digestive endoscopy was performed with endoscopes equipped with fiberoptic bundles, whereas the last decade was marked by the development of electronic endoscopes, characterized by the presence of a CCD (charge coupled device) at the tip of the endoscope. Thus the physician looks at a TV screen to control the procedure and examine in detail the gut wall. Endoscopes examine the foregut until the duodenum and the hindgut, up to the three last intestinal loops. When the endoscopic workstation comprises a computer, it is possible to acquire electronic images during the endoscopy and use these images as support of the information about the results of the procedure. These numeric images can then be stored in databases containing text attached to them. Starting with these images, one may expect many developments in the near future that will change the management of the patient with digestive diseases. Physicians will become able to exchange images and text related to one patient or one procedure, although they are equipped with different workstations. Therefore, it is obvious that the information exchanged must be written in a standard format that makes it understandable by all systems. The European Society of Gastrointestinal Endoscopy is a scientific society that groups most of the gastroenterologists in Europe. This society has initiated a research program to develop standards for the exchange of images and text. The Gastrointestinal Endoscopy Applications for Standards in Telecommunication, Education, and Research (GASTER) project intends to implement a multimedia database of endoscopic images based on a standard format of images and a standard terminology for descriptive terms. These standards must be validated by use in different endoscopy units. The database will collect images from these centers that will be linked to the coordinating center through a network based on an integrated services digital network (fast electronic connection). This database will then be used for the development of computer applications. The output of the GASTER project will bring advances at three levels: (1) The physicians will be able to exchange images about the procedures their patients have undergone and will thus obtain more complete information, improving quality of care. They will also benefit from help-to-decision applications based on validated reference images from the database. (2) At the patient level, the quality of care will be improved through a better dissemination of information between the physicians in charge of the patient, thus there is better follow-up of the patient and a decrease in redundant examinations. (3) At the level of national health care systems, the benefit will be a decrease in cost of care due to a better follow-up of the patients, a decrease in redundant examinations, and a faster decision made to treat the patient. The possibility of consulting a database of a scientifically validated images used as reference material will also improve quality control in digestive endoscopy.

Computer Communication Networks↗

Hands-on endoscopy training: an evaluation of the SADE endoscopy course. Scandinavian Association of Digestive Endoscopy.

The Scandinavian Association of Digestive Endoscopy course in advanced practical endoscopy has been arranged on a regular basis since 1980, representing a joint Scandinavian effort to offer hands-on endoscopy training with expert supervision at major endoscopy centers. The course has been aimed at gastroenterologists with previous endoscopic experience, focusing on special techniques, practical hints and expert solutions in special cases. Three days of practical training throughout Scandinavia are completed with two days of review lectures, case reports and special techniques. An inquiry among previous course participants indicates that the course has indeed been of practical value for their daily work, and that personal training as well as watching "experts at work" were useful for their ensuing endoscopic practice. The course model does, however, require close co-operation with the endoscopy units hosting the practical part of the course.

Curriculum↗

What are the clinical outcome and cost-effectiveness of endoscopy undertaken by nurses when compared with doctors? A Multi-Institution Nurse Endoscopy Trial (MINuET).

OBJECTIVES: To compare the clinical outcome and cost-effectiveness of doctors and nurses undertaking upper and lower gastrointestinal endoscopy. DESIGN: The study was a pragmatic randomised controlled trial. Zelen's randomisation before consent was used to minimise distortion of existing practice in the participating sites. An economic evaluation was conducted alongside the trial, assessing the relative cost-effectiveness of nurses and doctors. SETTING: The study was undertaken in 23 hospitals in England, Scotland and Wales. In six hospitals nurses undertook both upper and lower gastrointestinal endoscopy, yielding a total of 29 'centres'. The study was coordinated and managed from Swansea. Randomisation, data management and analysis were undertaken at York. Analysis was by intention-to-scope. PARTICIPANTS: Sixty-seven doctors and 30 nurses took part in the study. Of 4964 potentially eligible patients, 4128 (83%) were randomised. Of these, 1888 (45%) were recruited to the study from 29 July 2002 to 30 June 2003. INTERVENTIONS: The procedures under study were diagnostic upper gastrointestinal endoscopy and flexible sigmoidoscopy undertaken by nurses or doctors, with or without sedation, using the preparation, techniques and protocols of participating hospitals. MAIN OUTCOME MEASURES: Primary outcome measure was the Gastrointestinal Symptom Rating Questionnaire (GSRQ). The secondary outcome measures were EuroQol (EQ5D), Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ), State-Trait Anxiety Inventory (STAI), cost-effectiveness, immediate and delayed complications, quality of examination by blinded assessment of endoscopic video recordings, quality of procedure reports, patients' preferences for operator 1 year after endoscopy, and new diagnoses at 1 year. RESULTS: The two groups were well matched at baseline for demographic and clinical characteristics. Significantly more patients changed from a planned endoscopy by a doctor to a nurse than vice versa, mainly for staffing reasons. There was no significant difference between the two groups in the primary or secondary outcome measures at 1 day, 1 month or 1 year after endoscopy, with the exception of patient satisfaction at 1 day, which favoured nurses. Nurses were significantly more thorough in the examination of stomach and oesophagus, but no different from doctors in the examination of duodenum and colon. There was no significant difference in costs to the NHS or patients, although doctors cost slightly more. Although quality of life measures showed improvement in some scores in the doctor group, this did not reach traditional levels of statistical significance. Even so, the economic evaluation, taking account of uncertainty in both costs and quality of life, suggests that endoscopy by doctors has an 87% chance of being more cost-effective than endoscopy by nurses. CONCLUSIONS: There is no statistically significant difference between doctors and nurses in their clinical effectiveness in diagnostic endoscopy. However, nurses are significantly more thorough in the examination of oesophagus and stomach, and patients are significantly more satisfied after endoscopy by a nurse. Endoscopy by doctors is associated with better outcome at 1 year at higher cost, but overall is likely to be cost-effective. Further research is needed to evaluate the clinical outcome and cost-effectiveness of nurses undertaking a greater role in other settings, to monitor the cost-effectiveness of nurse endoscopists as they become more experienced and to assess, the effect of increasing the number of nurse endoscopists on waiting times for patients, and the career implications and opportunities for nurses who become trained endoscopists. Evaluation of the clinical outcome and cost-effectiveness of diagnostic endoscopy for all current indications is also needed.

Aged↗

Evaluation of a virtual endoscopy simulator for training in gastrointestinal endoscopy.

BACKGROUND AND STUDY AIMS: Skills in gastrointestinal endoscopy mainly depend on experience and practice. Training on endoscopy simulators may decrease the time needed to reach competency in endoscopy. The purpose of the study was to determine whether the GI-Mentor, a virtual reality endoscopy simulator, can distinguish between beginners and experts in endoscopy and to assess whether training improves the performance of beginners. METHODS: A total of 13 beginners and 11 experts (more than 1,000 procedures) in gastrointestinal endoscopy were included. The baseline assessment consisted of virtual endoscopies and skill tests. The beginners were randomly allocated to receive training (n = 7) or no training (n = 6). The training group was allowed to practice using the simulator for 2 hours per day. After 3 weeks participants were re-evaluated with two new virtual endoscopy cases and one virtual skill test. Insertion time, correctly identified pathologies, adverse events and skill test performance were recorded. RESULTS: The baseline assessment revealed significant differences favoring the experts for virtual endoscopies and skill tests. Significant differences in favor of experts were found for successful retroflection during esophagogastroduodenoscopy (EGD) (P < 0.005); adverse events during colonoscopy (P < 0.02); insertion time (P < 0.001); correctly identified pathologies in gastroscopy and colonoscopy (P < 0.02); and skill test performance (P < 0.01). The final evaluation showed significant differences between training and no-training groups, in favor of the training group, for the number of adverse events during virtual endoscopy (P < 0.04), for the insertion time during colonoscopy (P < 0.03); and for skill test performance (P < 0.01). The training group improved its abilities on the simulator significantly. Differences between experts and the training group were no longer seen. CONCLUSION: This virtual endoscopy simulator is capable of identifying differences between beginners and experts in gastrointestinal endoscopy. A 3-week training improves the performance of beginners significantly. This quite fast improvement in endoscopic skills certainly cannot be seen in clinical practice; no conclusions can be made about the impact of virtual simulator training on real-life endoscopy, and this must be evaluated.

Adult↗

Appropriateness and diagnostic yield of upper gastrointestinal endoscopy in an open-access endoscopy unit.

BACKGROUND AND STUDY AIMS: This prospective study tested the appropriateness of referrals for upper gastrointestinal endoscopy in an open-access endoscopy unit, using the criteria of the American Society for Gastrointestinal Endoscopy. It also examined whether there was any relationship between appropriateness of use and the presence of significant lesions detected by endoscopy. METHODS: Four hundred fifty consecutive upper gastrointestinal endoscopies were studied prospectively. The referral indication was recorded by the endoscopist before the procedure was performed, and was compared with the current criteria of the American Society for Gastrointestinal Endoscopy and with endoscopic findings. RESULTS: The appropriateness of referral was assessed in 442 consecutive endoscopies. Of these, 252 (57%) were judged to be appropriate. In 168 (88%) of the 190 endoscopies rated as inappropriate, the reason was that the patient had not undergone empirical anti-ulcer therapy before endoscopy. The probability of finding a significant lesion did not differ between the endoscopies judged to be appropriate (50%) and those judged to be inappropriate (46%) CONCLUSIONS: Upper gastrointestinal endoscopy was frequently used for inappropriate indications. The main reason for inappropriate use was insufficient treatment, or no treatment, of dyspeptic symptoms prior to endoscopy. In this study, the criteria for appropriateness did not predict the probability of finding a significant endoscopic lesion.

Adult↗

Virtual endoscopy of the nasal cavity in comparison with fiberoptic endoscopy.

PURPOSE: To apply virtual-endoscopic mode to display the nasal cavity and to evaluate clinical application of virtual endoscopy in comparison with nasal fiberoptic endoscopy. MATERIALS AND METHODS: Eleven patients were examined by virtual endoscopy after axial spiral computed tomography (CT) scanning was performed. In addition, 9 out of these 11 patients underwent fiberoptic endoscopy. Spiral CT scanning was performed with 1-mm collimation, 0.5- to 1-mm increment, 25-250 mA s, and pitch 1-2. Virtual endoscopy was performed by Explorer software package. RESULTS: Virtual endoscopy could clearly demonstrate anatomic structures in the nasal cavity, septal deviation, stenosis and obstruction of the middle meatus, turbinate hyperplasia, and pathological masses larger than 3 mm in diameter. However, "false adhesions" may appear in virtual endoscopy. The main limitation of virtual endoscopy was the inability to evaluate mucosa and its surface. CONCLUSION: Virtual endoscopy of the nasal cavity is a new and noninvasive method. It can demonstrate normal and pathological structures in the nasal cavity. Its ability to visualize is comparable with fiberoptic endoscopy except for evaluating mucosal surface and secretions. In the future, this method will probably be a basic instrument of computer-assisted surgery in the midfacial region.

Adult↗

Office-based unsedated small-caliber endoscopy is equivalent to conventional sedated endoscopy in screening and surveillance for Barrett's esophagus: a randomized and blinded comparison.

OBJECTIVES: A major limitation to screening and surveillance of Barrett's esophagus is the complexity, expense, and risk associated with sedation for upper endoscopy. This study examines the feasibility, accuracy, and patient acceptability of office-based unsedated endoscopy as an alternative. METHODS: Of 274 eligible adults scheduled for endoscopic screening for gastroesophageal reflux symptoms or surveillance of Barrett's esophagus at a tertiary care center, 121 underwent unsedated small-caliber endoscopy and conventional endoscopy in a randomized crossover study. The two procedures were compared with regard to histological detection of Barrett's esophagus and dysplasia and biopsy size. Patients answered questionnaires assessing the tolerability of the procedures. RESULTS: The prevalence of Barrett's esophagus was 26% using conventional endoscopy and 30% using unsedated endoscopy (P= 0.503). The level of agreement between the two approaches was "moderate" (kappa= 0.591). Each modality detected four cases of low-grade dysplasia with concordance on one case. The tissue samples collected with unsedated endoscopy were smaller than with conventional endoscopy (P < 0.001). The majority of subjects rated their experience with both procedures as being well tolerated with minimal or no difficulty. When asked which procedure they would prefer in the future, 71% (81/114) chose unsedated small-caliber endoscopy. CONCLUSIONS: Office-based unsedated small-caliber endoscopy is technically feasible, well tolerated, and accurate in screening for Barrett's esophagus, despite yielding a smaller biopsy specimen. This approach bears the potential to eliminate the infrastructure and cost required for intravenous sedation in this application.

Aged↗

Fiberoptic endoscopy of the gastrointestinal tract in infants and children. I. Upper endoscopy in 53 children.

Fiberoptic endoscopy of the upper gastrointestinal tract was performed on 53 patients without incident, ranging in age between two months and 18 years, of whom 35 were out patients at the time of examination. Of 27 patients with recurrent abdominal pain and normal upper gastrointestinal series, eight had abnormal findings at endoscopy: a duodenal ulcer in four, a gastric ulcer in two and duodenitis in two. Of 18 patients with hematemesis and/or melena, esophageal varices were demonstrated both by endoscopy and x-ray in two, gastric ulcer by endoscopy in three and x-ray in one, duodenal ulcer by endoscopy in three and by x-ray in two, esophagitis by endoscopy only in one patient, erosive gastritis by endoscopy in five and by x-ray in two and duodenitis by endoscopy in three and by x-ray in two. Of the remaining eight patients with abnormal x-rays findings and other symptomatology, endoscopy demonstrated foreign bodies in two (coins, esophagus and stomach), duodenitis in two, a gastric ulcer in one, a duodenal ulcer in one and normal examination in two. The data indicate that fiberoptic endoscopy significantly improves diagnostic accuracy in the evaluation of disorders of the upper gastrointestinal tract in children and is a safe and effective procedure in ambulatory pediatric patients.

Abdomen↗

The accuracy of an endoscopy nurse in interpreting capsule endoscopy.

OBJECTIVE: The average physician time required to view a wireless capsule endoscopy study at our institution is 50 min. It is unknown whether a nurse could preview the capsule endoscopy video and accurately detect all significant lesions. If so, it may allow the physician to review only the predetected abnormalities and thereby greatly reduce physician reading time. Our aim was to evaluate whether a nurse can accurately detect lesions on capsule endoscopy. METHODS: An endoscopy nurse who was trained to read capsule endoscopy reviewed 20 consecutive capsule endoscopy studies and recorded all findings. The same studies were viewed independently by a gastroenterologist. The two sets of recorded findings were reviewed, and a comparison of the accuracy in detecting landmarks and clinically significant lesions was made. RESULTS: The nurse missed two of 27 significant lesions seen by the gastroenterologist (93% sensitivity, 95% CI = 74-99%), and the gastroenterologist missed three seen by the nurse. The nurse accurately recorded gastric emptying time and time of passage through the ileocecal valve to within 1 min of the times recorded by the gastroenterologist in 18 of 20 patients (90% agreement, 95% CI = 67-98%). CONCLUSIONS: In this study, the endoscopy nurse detected 93% of the clinically significant lesions seen by the gastroenterologist. The clinical implication of this is that a physician extender could preread capsule endoscopies, allowing the gastroenterologist to view only the demarcated abnormalities. This could improve the cost effectiveness of capsule endoscopy and lead to wider physician acceptance of the test.

Clinical Competence↗

Guidelines of the European Society of Gastrointestinal Endoscopy (E.S.G.E.) antibiotic prophylaxis for gastrointestinal endoscopy. European Society of Gastrointestinal Endoscopy.

There are two situations when antibiotic prophylaxis is recommended. The first is associated with procedures known to be followed by high rates of bacteraemia, involving organisms prone to cause endocarditis. These include oesophageal dilatation, variceal sclerotherapy and laser therapy in the upper gastrointestinal tract. As bacteraemia following these procedures is usually harmless in average risk patients antibiotic prophylaxis is recommended only for a patient with a lesion susceptible to endocarditis or one who is at increased risk of symptomatic bacteraemia due to neutropenia or immunosuppression. In most cases parenteral amoxycillin and gentamicin is recommended plus metronidazole for neutropenic patients. Vancomycin or teicoplanin replace amoxycillin in a case of allergy. The second situation concerns procedures with a high incidence of local infection or which may lead to serious sepsis. These include therapeutic retrograde cholangiopancratography and percutaneous endoscopic gastrostomy where antibiotic prophylaxis is recommended even in average risk patients. Several antibiotics are recommended including oral ciprofloxacin or parenteral gentamicin or quinolone for ERCP and amoxycillin for PEG or cephalosporin or ureidopenicillin for both.

Adult↗

Open-access endoscopy: are age-based guidelines justified? An audit of experience of 1000 open-access endoscopies at a district general hospital.

BACKGROUND AND STUDY AIMS: Open-access endoscopy has been developed to meet the increasing demand for endoscopy, and guidelines have been produced for selecting suitable patients. This study was designed to assess the appropriateness of these guidelines in patients referred to open-access endoscopy services at a district general hospital. PATIENTS AND METHODS: A series of 1000 consecutive patients referred for open-access endoscopy was audited. The waiting time was 18 weeks and patients continued to take any acid-suppressing medication prescribed by their general practitioner. The endoscopy findings were compared in those who met and did not meet currently accepted guidelines. In addition the outcome for all patients in whom gastro-oesophageal malignancy was detected was reviewed. RESULTS: 301 patients (30.1 %) did not meet accepted guidelines for open-access endoscopy. No cases of malignancy would have been missed if the guidelines had been implemented. Gastro-oesophageal malignancy was detected in 17 patients, all of whom died. When malignancy was excluded, there were no statistically significant differences between the detection rates for pathology in the two groups. The commonest finding, in 32.3 % of patients, was of a normal endoscopic appearance. CONCLUSIONS: If current guidelines are applied, all cases of malignancy may be picked up, but identification of patients with curable disease is poor. Use of the guidelines did not select patients with other upper gastrointestinal disease, although many patients were receiving acid-suppression therapy at the time of their endoscopy. Implementation of test-and-treat strategies would result in a significant reduction in the workload of open-access endoscopy.

Adult↗

[Virtual MR endoscopy of the ventricles prior to neurosurgical interventional endoscopy -- evaluation of different presentation techniques].

PURPOSE: In the past, virtual endoscopies have been performed for planning of endoscopic interventions or for diagnostic purposes in various organ systems with increasing frequency. This study evaluates the ability of virtual ventricular endoscopy to depict anatomical structures and the use for planning of real endoscopy. MATERIALS AND METHODS: In a prospective study, 4 volunteers and 8 patients were examined with MRI. In 3 of the patients endoscopy was performed by our neurosurgeons thereafter. The calculation of the virtual endoscopy was based on 1 mm sagittal T2-weighted images. Comparison of surface rendering and volume rendering was made by means of video sequencing of individual views, and these were compared with the intraoperative endoscopic videos concerning the depictability of anatomical landmarks. RESULTS: The reconstructions using volume rendering were more significant and easier to calculate than those based on surface rendering. Virtual endoscopy in the transparent mode allowed visualization of hazardous structures outside the ventricular system such as the basilar artery tip. Transparent 3D images of the ventricles gave a good overview on the depicted structures and enabled a better orientation during the virtual camera flight than surface rendered views. CONCLUSION: MR-based virtual endoscopy of the ventricular system can be obtained on the basis of surface- and volume-rendered views of sagittal T2-weighted thin sections. Preoperative utilization of this method simplifies the planning of endoscopy by visualization of anatomical structures.

Brain Diseases↗

Does capsule endoscopy recognise gastric antral vascular ectasia more frequently than conventional endoscopy?

BACKGROUND: Gastric antral vascular ectasia (GAVE) is a rare cause of obscure gastrointestinal bleeding which can be difficult to recognise endoscopically. Capsule endoscopy is primarily designed to image the small bowel, but may identify gastric and colonic lesions. There have been few reported cases of GAVE diagnosed by capsule endoscopy in the literature. OBJECTIVE: Our aim was to assess the frequency of GAVE in patients with obscure gastrointestinal bleeding referred for capsule endoscopy. DESIGN: Case series. SETTING: This study was conducted in a tertiary referral hospital. PATIENTS. This study comprised 128 consecutive patients with obscure gastrointestinal bleeding. INTERVENTIONS: All patients underwent capsule endoscopy. RESULTS. Six patients were diagnosed with GAVE on the basis of the capsule endoscopy findings (4.7%, five female, median age 71.5 years). All patients had previously had numerous gastrointestinal investigations prior to capsule endoscopy. Five patients to date have been treated with argon plasma coagulation of their vascular lesions. This has resulted in stabilisation of their haemoglobin and cessation of blood transfusions in 4/5 cases with an average follow up period of 15 months. CONCLUSIONS: GAVE is commonly missed at gastroscopy and accounted for 4.7% of patients referred for capsule endoscopy with obscure gastrointestinal bleeding (in our series). This case series represents the largest number of GAVE recognised by capsule endoscopy. In the presence of any of the reported risk/associated factors for GAVE the gastroenterologist interpreting the capsule images should have a high index of suspicion.

Aged↗

Midazolam for patients undergoing upper gastrointestinal endoscopy: a prospective, single-blind and randomized study to determine the appropriate amount and time of initiation of endoscopy.

BACKGROUND AND AIMS: Midazolam is currently the most used sedative agent in endoscopy. The present study was designed to examine the appropriate dose of midazolam, time of initiation of endoscopy after midazolam infusion, and to prove the necessity of flumazenil as an antidote. METHODS: One hundred and eighty patients undergoing diagnostic gastroscopy were assigned three different amounts of intravenous midazolam in prospective, single-blinded and randomized setting as follows: (i) group I 0.03 mg/kg midazolam; (ii) group II 0.06 mg/kg midazolam; and (iii) group III 0.09 mg/kg midazolam. Endoscopy was initiated 30, 60 and 90 s after infusion of midazolam within each group. After endoscopy, patients were divided into two groups, one receiving flumazenil and one placebo in a double-blind fashion. The ease of the procedure, the conscious sedative state, the paradoxical response, the level of satisfaction and anterograde amnesia were assessed using a 100 mm visual analog scale. RESULTS: The endoscopist's assessments were not changed by the different doses of midazolam; however, significant differences were observed in the paradoxical responses (P < 0.05). The level of satisfaction with endoscopy was notably different between group I and the other two groups (P < 0.05). Amnesia was boosted according with increasing doses of midazolam (P < 0.05). The time until discharge after endoscopy was significantly different between group III and the other two groups (P < 0.05) and the discharge time was reduced in the flumazenil subgroup compared with the placebo subgroup in group III (P < 0.05). Group II (0.06 mg/kg) reported good levels of satisfaction, fewer paradoxical responses and short discharge time without any side-effects. Comparing the time of initiation of endoscopy (at 30, 60 and 90 s after midazolam) in each group, there were no significant differences in the level of satisfaction, conscious sedative state and amnesia. CONCLUSIONS: Midazolam should be administered at a dose of 0.06 mg/kg and the endoscopy should be initiated 30 s after midazolam injection for appropriate effects without any side-effects. Flumazenil is not necessary, except in the case of the use of a high dose (above 0.09 mg/kg) of midazolam.

Analysis of Variance↗

Transurethral resection for bladder cancer using 5-aminolevulinic acid induced fluorescence endoscopy versus white light endoscopy.

PURPOSE: Endoscopy done under fluorescence induced by 5-aminolevulinic acid has proved to be a procedure with high sensitivity for detecting transitional cell carcinoma of the bladder. In this multicenter, parallel group, phase III study we compared 5-aminolevulinic acid fluorescence endoscopy guided transurethral bladder resection with transurethral bladder resection done using only white light endoscopy. The proportion of tumor-free resected cases in the 2 groups was evaluated. MATERIALS AND METHODS: After patient stratification according to participating centers and European Organization for the Research and Treatment of Cancer risk score 65 and 64 were randomized to the 5-aminolevulinic acid fluorescence and white light endoscopy groups, respectively. Residual tumor was evaluated in the 2 groups by repeat transurethral resection 10 to 14 days later. Analysis was performed according to the intent to treat principle with all patients randomized, followed by per protocol analysis. RESULTS: Intent to treat analysis revealed that in the white light endoscopy group 40.6% of cases were resected tumor-free at primary resection, whereas with 5-aminolevulinic acid fluorescence endoscopy guided transurethral resection 61.5% were resected tumor-free (p <0014). On protocol analysis 46.9% patients in the white light and 67.3% in the 5-aminolevulinic acid fluorescence endoscopy groups were resected tumor-free (p <0.031). No difference was noted in the 2 groups in regard to side effects or laboratory findings. CONCLUSIONS: The risk of residual tumor after transurethral resection of transitional cell carcinoma is significantly decreased by 5-aminolevulinic acid fluorescence endoscopy.

Adult↗