Routine vs. on-demand analgesia in colonoscopy: a randomized clinical trial.

BACKGROUND AND STUDY AIMS: Colonoscopy is frequently performed with opioid analgesia, but the impact of drug delivery timing has not been studied in detail. Low-dose opioids administered before the procedure may provide better pain control than on-demand administration when the patient experiences pain. PATIENTS AND METHODS: A total of 119 outpatients were randomized to receive 50 µg of fentanyl either before colonoscopy (routine group) or on demand if needed during the colonoscopy (on-demand group). Additional fentanyl or midazolam was allowed in both groups if required. The primary outcome was pain measured on both a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst possible pain) and a four-point Likert scale (no, slight, moderate, or severe pain) immediately after the procedure. RESULTS: A total of 61 patients in the routine group and 58 patients in the on-demand group were included in the study. Mean VAS pain scores were 27.4 mm in the routine group and 30.5 mm in the on-demand group (mean difference - 3.2 mm; 95 % confidence interval - 11.9 to 5.5; P = 0.5). On the Likert scale, moderate or severe pain was experienced by 25.0 % and 31.5 % of patients in the routine and on-demand groups, respectively (p = 0.5). Cecal intubation rate and time to reach the cecum were similar between the groups. More patients in the on-demand group (81.0 %) than in the routine group (62.3 %) were able to leave the clinic without the need for recovery time (P = 0.03). CONCLUSION: Routine administration of fentanyl did not provide better analgesia during colonoscopy than on-demand fentanyl, and more patients needed time for recovery. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01786434).

[Pain in connection with colonoscopy in Norway]. / Smerter ved koloskopi.

BACKGROUND: Colonoscopies are common examinations at Norwegian hospitals. In contrast to many other countries, the majority of colonoscopies in Norway are conducted without routine sedation or analgesia. We wanted to investigate whether current Norwegian practice offers adequate pain relief. MATERIAL AND METHOD: The material consists of prospectively recorded outpatient colonoscopies in the period January 2003-December 2011 performed at Norwegian hospitals in the quality assurance network for gastrointestinal endoscopy (Gastronet). We analysed demographic patient data and data from colonoscopies. Patients' experience of pain (none, slight, moderate or severe pain) in connection with the examination was established with the aid of a validated questionnaire. RESULTS: Data from 61,749 colonoscopies (55% on women) performed at 29 different hospitals were analysed. Colonoscopies were perceived as moderately or very painful by 33% of the patients (41% of the women, 24% of the men, p < 0.001). There were substantial differences between hospitals as to the percentage of colonoscopies that were perceived as moderately or very painful (from 9% to 43%, p < 0.001) and the use of sedatives and analgesics for the colonoscopies (from 1% to 92% of the examinations, p < 0.001). Only 23% of those who found the colonoscopy painful received analgesics. Pethidine was used in 95% of the cases in which analgesics were used during the examination. INTERPRETATION: Many patients find colonoscopies painful. Pain relief practice varies substantially between hospitals. Pethidine is an analgesic with a slow onset of action, and should perhaps be replaced with more rapidly acting opiates.

Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial.

BACKGROUND: Knowing the position of the endoscope within the abdomen is important for performing a high-quality, painless colonoscopy. The recently introduced magnetic endoscopic imaging (MEI) system provides a continuous, real-time image of the endoscope during the entire procedure. OBJECTIVE: To compare MEI versus standard colonoscopy with on-demand fluoroscopy on unsedated patients, as performed by experienced and inexperienced endoscopists. DESIGN: Randomized, controlled trial. SETTING: Endoscopy outpatient clinic. PATIENTS: This study involved 810 consecutive patients (391 randomized to standard group; 419 randomized to MEI) referred for colonoscopy. INTERVENTION: MEI or standard approach (involving on-demand fluoroscopy) during colonoscopy. MAIN OUTCOME MEASUREMENTS: Perceived patient pain and cecal intubation rate and time to cecum. RESULTS: For inexperienced endoscopists, the cecal intubation rate was significantly higher in the MEI group (77.8%) compared with the standard group (56.0%), P = .02 but not for experienced endoscopists (94.0% for MEI and 96.0% for standard group, P = .87). Inexperienced endoscopists had less need for assistance from a senior colleague when they used MEI (18.5%) compared with the standard technique (40.0%), P = .02. Mean (± standard deviation) time to reach the cecum was 14.0 ± 12.2 minutes in the MEI group and 15.3 ± 14.2 minutes in the standard group, P = .67. LIMITATIONS: Single center, unblinded study. CONCLUSION: Inexperienced endoscopists improved their colonoscopy performance when they used MEI, compared with the standard technique, but experienced endoscopists did not. The MEI may be advantageous to use for colonoscopy centers educating endoscopists. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00519129.).

Sustaining the vitality of colonoscopy quality improvement programmes over time. Experience from the Norwegian Gastronet programme.

OBJECTIVE: An important challenge of any quality assurance (QA) programme is to maintain interest among participants to ensure high data quality over time. The primary aim of this study was to identify factors associated with endoscopist compliance with the Norwegian QA programme for colonoscopies (Gastronet). MATERIAL AND METHODS: The Gastronet registration tools are an endoscopy report form to be filled in directly after the procedure by the endoscopist, and a satisfaction questionnaire to be filled in by the patient on the day after the examination. During the study period from 1 January 2004 to 31 December 2006, endoscopist compliance was measured by assessing patient report coverage, defined as the percentage of patient satisfaction questionnaires received by the Gastronet secretariat divided by the total number of colonoscopy reports registered by the individual endoscopists during the study period. Multivariate logistic regression models were applied to identify individual factors related to patient report coverage. RESULTS: Eighty-eight endoscopists from 10 hospitals contributed a total of 16,149 colonoscopies. Overall patient report coverage decreased from 87% in 2004 to 80% in 2006. A low patient report coverage was associated with time since the registrations started [odds ratio (OR) 0.98, 95% confidence interval (CI) 0.97-0.98; P < 0.001], use of sedation (OR 0.7, 95% CI 0.61-0.76; P < 0.001), and incomplete colonoscopy (OR 0.6, 95% CI 0.54-0.76; P < 0.001). CONCLUSIONS: Decreasing compliance with registration over time may compromise data quality and the validity of the results. Lower coverage of patient's reports (presumably for the most difficult examinations) may lead to erroneous conclusions regarding colonoscopy performance.

Results of faecal donor instillation therapy for recurrent Clostridium difficile-associated diarrhoea.

We report a success rate of 83% with faecal donor instillation therapy (FDIT) in this retrospective study of 40 patients with recurrent Clostridium difficile-associated diarrhoea (CDAD), treated at a medium sized Norwegian hospital from 1994 through 2008. The stool transplant was instilled either in the duodenum through a gastroscope or in the colon through a colonoscope with next of kin or other household member as donor. In 29 cases (73%) the first treatment was successful, with no documented recurrence of diarrhoeal disease within 80 days. Of the 11 patients failing to respond to the first instillation treatment, 6 patients received a second instillation, 4 of which were successful. A total of 33 patients (83%) were successfully treated with FDIT. Of the 7 non-responders, 5 were seriously ill due to long lasting diarrhoeal disease and co-morbidity and died within 80 days after the procedure, and 2 were believed to have inflammatory bowel disease with response to corticosteroid treatment. No adverse effects of FDIT were observed. In our experience the procedure is easy to perform, well tolerated, effective, and may be a valuable treatment option in selected cases.

Effect of oral lansoprazole on intragastric pH after endoscopic treatment for bleeding peptic ulcer.

OBJECTIVE: Intravenous proton pump inhibitors (PPIs) induce a high intragastric pH and may thereby improve haemostasis in patients with bleeding peptic ulcer. The aim of this study was to investigate whether a similar therapeutic intragastric pH level could be reached when the PPI was administered orally. MATERIAL AND METHODS: Twenty-four-hour intragastric pH was measured in patients treated endoscopically for bleeding peptic ulcer (Forrest class I or II). The patients received lansoprazole capsules (90 mg) after successful endoscopic treatment, followed by 30 mg every third hour for 72 h. The primary end-point was the percentage of the 0 to 24-h registration period with an intragastric pH of 6 or higher. Additionally, the total number of patients obtaining an intragastric pH above 6 for 80% or more of the 0 to 24-h period after start of treatment was evaluated. RESULTS: Of the 14 patients included in the study (4 F, mean age 74 years, range 50-84 years), 10 patients had duodenal ulcer and 4 had gastric ulcer; median lowest Hgb: 8.9 mg/ml (range 5.8-12.4), blood transfusions: 2.7 SAG units (range 0-7). In the 0 to 24-h period, the median time duration of pH above 6 was 55% (range 6-99). One out of 14 patients (7%) reached a pH above 6 in at least 80% of this time period. CONCLUSIONS: An increase in intragastric pH of therapeutic importance was reached with this oral medication regimen. However, there were large intra-individual differences. Treatment with oral lansoprazole may be a therapeutic alternative to intravenous administration of PPI.

Cecum intubation rate as quality indicator in clinical versus screening colonoscopy.

BACKGROUND AND STUDY AIMS: Some guidelines recommend a minimum standard of 90 % cecal intubation rate (CIR) in routine clinics and 95 % in screening colonoscopy, while others have not made this distinction - both with limited evidence to support either view. This study questions the rationale for making such differentiation. PATIENTS AND METHODS: We assessed cecum intubation rates amongst colonoscopies recorded in the Norwegian national quality register Gastronet by 35 endoscopists performing both clinical and screening colonoscopies. Colonoscopies were categorized into primary screening colonoscopy, work-up colonoscopy of screen-positives and clinical colonoscopy or surveillance. Cases with insufficient bowel preparation or mechanical obstruction were excluded. Endoscopists were categorized into "junior" and "senior" endoscopists depending on training and experience. Univariable and multivariable logistic regression analyses were applied. RESULTS: During a 2-year period, 10,267 colonoscopies were included (primary screening colonoscopy: 746; work-up colonoscopy of screen-positives: 2,604; clinical colonoscopy or surveillance: 6917). The crude CIR in clinical routine colonoscopy, primary screening colonoscopy and work-up colonoscopy was 97.1 %, 97.1 % and 98.6 %, respectively. In a multiple logistic regression analysis, there were no differences in CIR between the 3 groups. Poor bowel cleansing and female sex were independent predictors for intubation failure. CONCLUSION: Cecal intubation rate in clinical colonoscopies and colonoscopy screening are similar. There is no reason to differentiate between screening and clinical colonoscopy with regard to CIR.

The Norwegian Gastronet project: Continuous quality improvement of colonoscopy in 14 Norwegian centres.

OBJECTIVE: The burden on colonoscopy capacity is considerable and expected to increase further as colorectal cancer screening programmes gain a foothold in Europe. In this situation, it is particularly important to evaluate the quality of the service given. In this article we present our first year of experience with a quality network of endoscopy centres in Norway (Gastronet). MATERIAL AND METHODS: A questionnaire focusing on caecal intubation rate and pain was completed by the endoscopist (on site) and patient (on the day after the examination). Fourteen centres participated with registration of 7370 colonoscopies by 73 endoscopists. RESULTS: There was 100% endoscopist participation, 87% coverage of colonoscopies and an estimated 76% questionnaire coverage of the patient population. Overall caecal intubation rate was 91%, range 83% to 97% between centres (p < 0.001). Patients reporting severe pain during colonoscopy differed from 2 to 24% between centres (p < 0.001). Variations could only partly be explained by differences in procedure practice (sedation, CO2 insufflation). For individual endoscopists, improvement after feedback on performance was restricted to the group of endoscopists having contributed with only 50-99 registered colonoscopies. CONCLUSIONS: In quality assurance programmes we recommend a limited number of variables for registration in order to secure high compliance by endoscopists and patients. One year of experience with Gastronet disclosed a satisfactory overall caecal intubation rate, but considerable variation between centres in practice and ability to offer painless colonoscopy. This suggests a need for formal, centralized training of colonoscopists or the development of quality standards for colonoscopy training and practice.