Background: In Germany, screening colonoscopy was first established in 2002 as part of the national cancer screening program.Objective: To evaluate whether colorectal cancer (CRC) survival differs when CRC is diagnosed by screening colonoscopy (S-CRC) versus diagnostic colonoscopy (D-CRC).Design: Long-term, retrospective, multicenter, observational study.Setting: Study centers: 10 private gastroenterology practices in Germany.Patients: A total of 60 patients diagnosed with CRC during screening colonoscopy and 252 patients during diagnostic colonoscopy in 2002, 2003, and 2004.Interventions: Colonoscopy.Main Outcome Measurements: Survival of patients up to December 2013.Results: Mean (+/- standard deviation [SD]) follow-up time was 81.0 (+/- 40.1) months. Union Internationale Contre le Cancer (UICC) stages I and II were found more often in S-CRC (81.6%) compared with D-CRC (59.9%; P < .002). Kaplan-Meier analysis showed significantly reduced overall survival for patients with D-CRC (mean [+/- SD] 86.9 [+/- 3.0] months; 95% confidence interval [CI], 81.0-92.8) compared with S-CRC (mean [+/- SD] 107.1 [+/- 4.9] months; 95% CI, 97.4-116.9; P = .003). When deaths not related to CRC were excluded, survival was still shorter for D-CRC patients (mean [+/- SD] 89.4 [+/- 3.0] months; 95% CI, 83.5-95.4) compared with S-CRC (mean [+/- SD] 109.6 [+/- 4.7] months; 95% CI, 100.2-119.0; P = .004). Limitations: Retrospective study design.Conclusion: In this long-term, retrospective study, patients with CRC diagnosed during screening colonoscopy lived significantly longer when compared with patients with CRC diagnosed during diagnostic colonoscopy.

Background & Aims: Respiratory complications represent an important adverse event of endoscopic procedures. We screened for respiratory complications after endoscopic procedures using a questionnaire and followed-up patients suggestive of respiratory infection.Method: In this prospective observational, multicenter study performed in Outpatient practices of gastroenterology we investigated 15,690 patients by questionnaires administered 24 hours after the endoscopic procedure.Results: 832 of the 15,690 patients stated at least one respiratory symptom after the endoscopic procedure: 829 patients reported coughing (5.28%), 23 fever (0.15%) and 116 shortness of breath (SOB, 0.74%); 130 of the 832 patients showed at least two concomitant respiratory symptoms (107 coughing + SOB, 17 coughing + fever, 6 coughing + coexisting fever + SOB) and 126 patients were followed-up to assess their respiratory complaints. Twenty-nine patients (follow-up: 22.31%, whole sample: 0.18%) reported signs of clinically evident respiratory infection and 15 patients (follow-up: 11.54%; whole sample: 0.1%) received therefore antibiotic treatment. Coughing or vomiting during the endoscopic procedure resulted in a 156.12-fold increased risk of respiratory complications (95% CI: 67.44 - 361.40) and 520.87-fold increased risk of requiring antibiotic treatment (95% CI: 178.01 - 1524.05). All patients of the follow-up sample who coughed or vomited during endoscopy developed clinically evident signs of respiratory infection and required antibiotic treatment while this occurred in a significantly lower proportion of patients without these symptoms (17.1% and 5.1%, respectively).Conclusions: We demonstrated that respiratory complications following endoscopic sedation are of comparably high incidence and we identified major predictors of aspiration pneumonia which could influence future surveillance strategies after endoscopic procedures.

Background and AimSince 2008, there exists a German S3-guideline allowing non-anesthesiological administration of propofol for gastrointestinal endoscopy. In this prospective, national, multicenter study, we evaluated the safety of endoscopist-administered propofol sedation (EDP) in German outpatient practices of Gastroenterology.MethodsIn this multicenter survey of 53 ambulatory practices of Gastroenterology, we prospectively evaluated 24441 patients that had received EDP. We recorded adverse events during the endoscopic procedure and additionally retrieved questionnaires investigating subjective parameters 24h after the endoscopic procedure.ResultsIn 24441 patients 13793 colonoscopies, 6467 esophagogastroduodenoscopies, and 4181 double examinations were performed. In this study, 52.1% of the patients received propofol mono-sedation, and 47.9% received a combination of midazolam and propofol. Major adverse events occurred in four patients (0.016%) enrolled to this study (three mask ventilations and one laryngospasm). Minor adverse events were observed in 112 patients (0.46%) with hypoxemia being the most common minor event. All patients with adverse events recovered without persistent impairment. Minor adverse events occurred more frequently in patients sedated with propofol mono compared to propofol and midazolam (P<0.0001) and correlated with increasing propofol dosages (P<0.001; Pearson correlation coefficient r=0.044). Twenty-four hours after the endoscopy, patients sedated with propofol plus midazolam stated a significantly reduced sensation of pain (P<0.01) and improved symptoms of dizziness, nausea and vomiting (P<0.001) compared to patients having received propofol mono-sedation.ConclusionFour years after the implementation of a German S3-Guideline for endoscopic sedation, we demonstrated that EDP is a safe procedure.

Aims of the study: In this prospective multicenter trial of 24.441 patients we evaluated the occurrence of adverse events and patients subjective condition regarding the sedation regimen of Propofol mono (P) or a combination of Propofol and Midazolam (P+M).

BACKGROUND:The incidence of adverse events (AEs) is a crucial factor when colonoscopy is considered for mass screening, but few studies have addressed delayed and non-GI AEs. OBJECTIVES:To investigate the risk of AEs requiring hospitalization after screening and nonscreening colonoscopies compared with control subjects who did not undergo colonoscopy. DESIGN:Retrospective matched cohort. SETTING:Statutory health insurance fund in Germany. PATIENTS:A total of 33,086 individuals who underwent colonoscopy as an outpatient (8658 screening, 24,428 nonscreening) and 33,086 matched controls who did not undergo colonoscopy. INTERVENTIONS:Outpatient screening and nonscreening colonoscopies. MAIN OUTCOMES MEASUREMENTS:Risk of AEs (perforation, bleeding, myocardial infarction, stroke, splenic injury, and others) requiring hospitalization within 30 days after colonoscopy/index date and risk differences between the group that underwent colonoscopy and the group that did not. RESULTS:The incidence of perforation was 0.8 (95% confidence interval [CI], 0.3-1.7) and 0.7 (95% CI, 0.4-1.1) per 1000 screening and nonscreening colonoscopies, respectively. Hospitalizations because of bleeding occurred in 0.5 (95% CI, 0.1-1.2) and 1.1 (95% CI, 0.8-1.7) per 1000 screening and nonscreening colonoscopies, respectively. The incidence of myocardial infarction, stroke, and other non-GI AEs was similar in colonoscopy and control groups. No splenic injury was observed. Those with AEs generally had a higher mean age and comorbidity rate than the overall study population. LIMITATIONS:The analysis relies on health insurance claims data. CONCLUSIONS:This study provides further evidence of the safety of colonoscopy in routine practice with regard to delayed and non-GI AEs. Hospitalizations because of the investigated AEs were uncommon or rare for both screening and nonscreening colonoscopies.

Study aims: We investigated the incidence of aspiration pneumonie during outpatient endoscopic sedation.

Leitlinienprogramm Onkologie der AWMF, Deutschen Krebsgesellschaft e. V. und Deutschen Krebshilfe e. V.

Capsule endoscopy is the first‐line diagnostic technique for the small bowel. However, the inability to visualize the duodenal papilla is an inherent limitation of this method. In the present study, we evaluated feasibility of a newly developed CapsoCam SV1 capsule.

BACKGROUND & AIMSDue to improved patient satisfaction and its pharmacological benefits, more endoscopic procedures are carried out with the use of propofol. However, recent rulings in the USA challenge endoscopist-administered propofol sedation. We evaluated the safety of endoscopist-administered propofol sedation in a German outpatient practice.METHODSDuring a period of 65 months, we prospectively evaluated 10,000 patients who received endoscopic procedures. During 377 endoscopic procedures we performed extensive blood pressure observation. Propofol was administered via intermittent i.v. bolus titration by trained practice nurses under the supervision of the gastroenterologist. Oxygen saturation, heart rate and blood pressure were recorded constantly during the procedure and adverse cardiopulmonary events were monitored by the endoscopy team. A major respiratory event was defined as an episode of apnea or laryngospasm requiring assisted ventilation.RESULTS13,764 endoscopic procedures were recorded in 10,000 patients (7,349 esophago-gastro-duodenoscopies (ESD), 6,415 colonoscopies); 9,654 patients were sedated with propofol (ESD: 115 +/- 35; colonoscopy: 155 +/- 52; combined: 199 +/- 55 mg) and 346 patients had endoscopic examination without sedation. 0.03% of the patients received mask ventilation due to apnea and in 0.39% minor events of hypoxemia (oxygen saturation < 90%) were recorded. Bradycardia and arterial hypotension occurred in 0.07% and 0.24% of the patients. Patients with adverse events were significantly older than patients without (P < 0.001).CONCLUSIONThe low number of adverse events recorded in this prospective study concludes that endoscopist-administered propofol sedation is a safe procedure. It does not seem likely that additional support of an anaesthetist would further improve patient's safety, and particularly cost-efficiency.

Ziel der Studie: Ziel dieser prospektiven Multicenterstudie ist die Erfassung unerwünschter Nebenwirkungen der Propofolsedierung durch den niedergelassenen Gastroenterologen. Die geplante Fallzahl dieser prospektiven Studie beträgt 50.000 Patienten.

Colon capsule endoscopy (CCE) may be a means to overcome the low adherence to colorectal cancer screening. The device is an ingestible capsule with a video camera at both ends that can take photographs as it progresses through the gastrointestinal tract. PillCam colon (PCC1) may be used for structural evaluation of the large bowel following an adequate cleaning procedure. PCC1 measures 11 mm × 31 mm and has dual cameras that enable the device to acquire video images from both ends with a wide coverage area, automatic light control and a frame rate of four frames per second. The system includes a sensor array and data recorder connected to the patient during the procedure. The recorded data are downloaded to the Given Imaging Rapid workstation for review of the colon video. The second generation of PillCam Colon (PCC2) is similar to PCC1 and incorporates new developments. The angle of view has been increased to 172 degrees. It has an adaptive frame rate, alternating from 35 frames per second while in motion to 4 images when virtually stationary. The new RAPID(®) software now includes a simple graphic interface tool for polyp size estimation. The procedure of bowel cleansing until capsule ingestion is similar to that used for traditional colonoscopy. However it is more rigorous as the bowel cleanliness for capsule colonoscopy has to be excellent or at least good to result in an adequate sensitivity of the method. Briefly, it consists of 3.5-4 L of split dose polyethylene glycol. Oral NaP boosters are administered after 1-2 h if the capsule has entered the small bowel. Sodium phosphate (NaP) seems to be a necessary adjunct to the regimen because the total transit time is doubled without NaP. The cleansing level was considered to be good to excellent in 72%-88% in studies with PCC1. The sensitivity for significant polyps (> 6 mm or more than 3 polyps >3 mm) ranged from 63%-88% with specificities between 64%-94%. PCC2 showed an improved sensitivity of 89% and a specificity of 76%. CCE seems to be a safe and effective method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation of air. The sensitivity of CCE to detect polyps, advanced adenomas and cancer is lower compared to optical colonoscopy but improvements will be made in the near future. With an increased recording duration, even a panenteric examination of the whole gastrointestinal tract may be possible.

Capsule endoscopy has evolved to become a first-line, noninvasive diagnostic technique for the small bowel. However, the inability to visualize the duodenal papilla is an inherent limitation of this method. We evaluated the diagnostic yield and completeness of the small bowel examination with a newly developed video capsule (SV1, Capsovision, Saratoga, CA) with panoramic imaging.

OBJECTIVES: Colorectal cancer (CRC) screening with colonoscopy was introduced into the National Cancer Prevention Program in Germany in 2002. As compliance for screening is low (around 3% per year), colon capsule endoscopy (CCE) could be an alternative approach. In this study, feasibility and performance of CCE were evaluated in comparison with colonoscopy in ambulatory patients with special attention to a short colon transit time.METHODS: CCE was prospectively tested in ambulatory patients enrolled for colonoscopy who presented for screening or with positive fecal occult blood test. Study subjects underwent colon preparation and ingested the capsule in the morning. Colonoscopy was performed after excretion of the capsule. Colonoscopy and CCE were performed by independent physicians who were blinded to the results.RESULTS: In total, 38 patients were included. One patient was excluded because the capsule remained in the stomach during the entire period of examination. Another patient had limited time and the procedure had to be stopped when the capsule was still in the transverse colon. We therefore report the results of 36 patients (30 men and 6 women; mean age 56 years, range 23-73 years) who successfully completed CCE and the conventional colonoscopy examination. The capsule was excreted within 6 h in 84% of the patients (median transit time 4.5 h). If oral sodium phosphate was excluded from the preparation, the colon transit time increased to a median of 8.25 h. In total, 7 of 11 small polyps (<6 mm) detected by colonoscopy were identified by CCE. One small polyp detected by CCE was not identified by colonoscopy. In this series, no large polyps were found. One CRC was detected by both methods. The mean rates of colon cleanliness (range from 1 = excellent to 4 = poor) in the cecum (2.1), transverse colon (1.6), and in the descending colon (1.5) were significantly better than in the rectosigmoid colon (2.6), and the overall mean rate during colonoscopy was significantly better than during CCE. No adverse effects occurred.CONCLUSIONS: CCE appears to be a promising new modality for colonic evaluation and may increase compliance with CRC screening. To achieve a short colon transit time, sodium phosphate seems to be a necessary adjunct during preparation. The short transit time is a prerequisite to abandon the delay mode of the capsule. With an undelayed PillCam COLON capsule, a "pan-enteric" examination of the gastrointestinal tract would be possible. Further studies are needed to improve the cleanliness, especially in the rectum and to evaluate the method as a potential screening tool.

Introduction[nl]1 Indications/goals/known risks/patients/quality goals[nl]1.1 Recommendation on sedation choices[nl]1.2 Recommendation on indications for sedation[nl]1.3 Recommendation on examination quality[nl]1.4 Recommendation on risk assessment and structure quality[nl]1.4.1 General[nl]1.5 Recommendation on anesthesia/intubation[nl]1.6 Recommendation on protective intubation[nl]1.7 Recommendation on patient positioning[nl]2 Sedatives/analgesics/drugs acting on the autonomic nervous system/combination therapy/methods of administration[nl]2.1 Acceptance by the patient and the endoscopist[nl]2.1.1 Patient acceptance/satisfaction[nl]2.1.2 Endoscopist satisfaction[nl]2.2 Monotherapies[nl]2.2.1 Propofol[nl]2.2.2 Benzodiazepines[nl]2.2.3 Propofol versus midazolam[nl]2.2.4 Other drugs as monotherapeutics[nl]2.3 Combination therapies[nl]2.3.1 General[nl]2.3.2 Specific combinations[nl]2.3.3 Side effects of combination therapy[nl]2.3.4 Monitoring/structure quality[nl]2.4 Effect of co-morbidity[nl]2.4.1 General[nl]2.4.2 High-risk patients[nl]2.4.3 Substance type[nl]2.5 Music during endoscopy[nl]3 Structure quality: personal/personnel/equipment requirements[nl]Introduction[nl]3.1 Personal requirements[nl]3.2 Education and training courses[nl]3.3 Personnel requirements[nl]3.3.1 Education requirements[nl]3.3.2 Sedation monitoring[nl]3.3.3 Carrying out the sedation[nl]3.3.4 Monitoring after the endoscopic procedure[nl]3.4 Facilities requirements[nl]3.5 Equipment[nl]3.5.1 Clinical monitoring/standard monitoring[nl]3.5.2 Extended monitoring[nl]4 Informed consent/prerequisites for performance of sedation/preservation of vital functions/clinical monitoring/emergency management[nl]4.1 Informed consent of the patient[nl]4.1.1 General and legal aspects[nl]4.1.2 Informing person[nl]4.1.3 Informed consent procedure[nl]4.1.4 Content of the patient information interview[nl]4.1.5 Safety information (patient do’s and don’t’s after endoscopic sedation)[nl]4.2 Requirements for carrying out sedation[nl]4.3 Protection of vital functions[nl]4.4 Management of sedation-related emergencies[nl]4.4.1 Hypoxemia[nl]4.4.2 Cardiac arrhythmias[nl]4.4.3 Arterial hypotension[nl]4.4.4 Myocardial ischemia[nl]4.4.5 Rare events during sedation[nl]5 Quality goals: internal quality assurance/discharge criteria/fitness for road traffic/ability to work/documentation/benchmarking[nl]5.1 Internal quality assurance[nl]5.2 Discharge criteria[nl]5.2.1 Patient instructions[nl]5.2.2 Minimum criteria for discharge[nl]5.2.3 Use of score systems for discharge[nl]5.3 Fitness for road traffic[nl]5.4 Documentation[nl]5.4.1 General[nl]5.4.2 Inability to work[nl]5.5 Benchmarking

Da zu dem Themenkomplex der Strukturqualität derzeit keine prospektiven Studien existieren, wurden für die Empfehlungen fast ausnahmslos die bereits vorhandenen Leitlinien und Empfehlungen herangezogen.