"Appropriateness" or "prioritization" for GI endoscopic procedures?
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Biomedical subjects
Publications and source records attributed to Vittorio Terruzzi.
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OBJECTIVE: To compare the efficacy and patient acceptance of an oral high dose of senna to conventional polyethylene glycol-electrolyte lavage solution (PEG-ES) in adults undergoing elective colonoscopy. METHODS: Consecutive outpatients referred for elective colonoscopy were prospectively randomly assigned to receive, the day before the procedure, either 24 tablets of 12 mg senna, divided into two doses at 1 p.m. and 9 p.m. (senna group, n=191), or standard 4-L PEG-ES (PEG-ES group, n=92). The overall quality of colon cleansing (primary outcome measure) and cleansing in the right colon were evaluated using the Aronchick scoring scale (1=excellent to 4=inadequate) by the investigator/endoscopist who was blinded to the treatment assignment. Patient acceptance and the safety of the preparation were assessed by a nurse, using a structured questionnaire covering compliance with the dosing, overall tolerance of the preparation (1=none or mild discomfort to 4=severely distressing), and adverse events. RESULTS: The quality of colon cleansing, overall tolerance of the preparation, and compliance were significantly better with senna; overall cleansing was excellent or good in 90.6% of patients in the senna group and in 79.7% in the PEG-ES group (p= 0.003). The percentage of procedures rescheduled because of insufficient colon cleansing was 7.3% in the PEG-ES group and 2.6% in the senna group (p=0.035). Multivariate logistic regression modeling showed the PEG-ES preparation as negative independent predictor of unsuccessful bowel cleansing. The incidence of adverse reactions was similar in the two groups; patients who received senna experienced significantly less nausea and vomiting, but more abdominal pain. CONCLUSIONS: An oral high dose of senna is a valid alternative to standard PEG-ES for outpatient colonoscopy preparation.
The practice of sedation and analgesia is under increasing scrutiny by numerous regulatory agencies, with the aim of making these procedures safer and reducing the incidence of cardiopulmonary complications during GI endoscopy. As we move toward more evidence-based medicine, new technologies will have to be assessed in a manner that demonstrates their efficacy and utility in clinical practice. Although there have been no controlled studies examining whether more intensive monitoring during endoscopy improves outcomes, extended monitoring with capnography seems to offer an advantage over conventional monitoring in that, by providing a real-time indication of any change in adequate ventilation before oxygen desaturation occurs, it can detect early phases of respiratory depression, which can allow a more precise and safer titration of medications. There is a close agreement among experts that capnography may reduce the risk of adverse outcomes during deep sedation; therefore, its use should be required for patients undergoing advanced endoscopic procedures with the potential for deep sedation. Extended monitoring with capnography should also be endorsed whenever propofol is considered as an alternative to standard sedation with a benzodiazepine or narcotic. Our understanding of the clinical application of techniques for monitoring of depth of sedation is in its infancy, and its full contribution to the practice of endoscopy has yet to be determined. Their potential role in improving sedation practice during endoscopy needs to be confirmed by controlled trials. If we consider the lack of proven efficacy of these emerging monitoring techniques in reducing the adverse outcomes associated with sedation and analgesia, the importance of appropriate monitoring cannot be overemphasized. However, it is vital for the endoscopist to be thoroughly familiar with the type of sedation chosen, to be able to recognize the various levels of sedation, and, above all, to rescue patients should they unintentionally progress to a deeper level of sedation than intended.
BACKGROUND & AIMS: It still is debated whether post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis can be prevented by administering either somatostatin or gabexate mesylate. The aim of the study is to assess the efficacy of a 6.5-hour infusion of somatostatin or gabexate mesylate in preventing ERCP-related complications. METHODS: In a double-blind multicenter trial, 1127 patients undergoing ERCP were randomly assigned to intravenous administration of somatostatin (750 microg; n = 351), gabexate mesylate (500 mg; n = 381), or placebo (saline; n = 395). The drug infusion started 30 minutes before and continued for 6 hours after endoscopy. Patients were evaluated clinically, and serum amylase levels were determined at 4, 24, and 48 hours after endoscopy. RESULTS: No significant differences in incidences of pancreatitis, hyperamylasemia, or abdominal pain were observed among the placebo (4.8%, 32.6%, and 5.3%, respectively), somatostatin (6.3%, 26.8%, and 5.1%, respectively), and gabexate mesylate groups (5.8%, 31.5%, and 6.3%, respectively). Univariate analysis of patient characteristics and endoscopic maneuvers showed that a Freeman score >1 (P < 0.0001), >/=3 pancreatic injections (P < 0.00001), and precut sphincterotomy (P = 0.01) were significantly associated with post-ERCP pancreatitis. At multiple logistic regression analysis, >/=3 pancreatic injections (odds ratio [OR], 1.95; 95% confidence interval [CI], 1.45-2.63) and a Freeman score >1 (OR, 1.47; 95% CI, 1.11-1.94) retained their predictive power. CONCLUSIONS: Long-term (6.5-hr) administration of either somatostatin or gabexate mesylate is ineffective for the prevention of post-ERCP pancreatitis. Pancreatic injury seems to be related to difficulty in common bile duct access.
BACKGROUND: The aim of this study was to determine whether a single bolus of meperidine in addition to midazolam improves patient tolerance during colonoscopy. METHODS: Consecutive patients undergoing outpatient colonoscopy were randomly assigned in double-blind fashion to receive a single rapid intravenous bolus of 5 mg of midazolam and placebo (Group A, n = 125) or 5 mg midazolam plus 50 mg meperidine (Group B, n = 128). Tolerance (4-point scale: 1 excellent, 4 unbearable), pain (4-point scale: 1 none, 4 severe) and willingness to undergo another colonoscopy were assessed 24 to 48 hours later in a telephone interview conducted by an independent observer blinded to the regimen of sedative medication. RESULTS: Significantly more patients in Group A reported moderate or severe pain (28% vs. 9%; p < 0.001), poor or unbearable tolerance (18% vs. 6%; p < 0.01) and unwillingness to undergo colonoscopy again in the future (14% vs. 5%; p < 0.05). By multivariate analysis, randomization to the midazolam group and younger age were the only variables independently associated with the risk of reporting at least one of these outcomes. Recovery time, frequency of oxygen desaturation, and need for supplemental oxygen were not significantly different between the 2 groups. CONCLUSIONS: The addition of a single bolus of meperidine to midazolam improves patient tolerance and lessens pain during colonoscopy without significantly increasing the frequency of side effects or prolonging recovery time.
BACKGROUND: ERCP is frequently complicated by pancreatitis. The aims of this study were to assess the efficacy of somatostatin and gabexate for prevention of post-ERCP pancreatitis in high-risk patients and to determine predisposing factors for post-ERCP pancreatitis. A meta-analysis was conducted of all published studies on the use of somatostatin or gabexate for prevention of post-ERCP pancreatitis. METHODS: A double blind, multicenter, placebo-controlled trial was conducted in patients at high risk for post-ERCP pancreatitis. Patients were randomized to receive an intravenous infusion of somatostatin (750 mg), gabexate (500 mg), or placebo that was started 30 minutes before endoscopy and continued for 2 hours afterward. Patients were evaluated clinically and serum amylase levels determined at 4 and 24 hours after endoscopy. RESULTS: No significant difference in the occurrence of pancreatitis, hyperamylasemia, or abdominal pain was observed among placebo-, gabexate-, and somatostatin-treated patients. A sphincterotomy longer than 2 cm (p = 0.0001), more than 3 pancreatic injections (p = 0.0001), and unsuccessful cannulation (p = 0.008) were predictive of post-ERCP pancreatitis. Hyperamylasemia was predicted by more than 3 pancreatic injections (p = 0.0001) and sphincterotomy (p = 0.02). The meta-analysis of trials of short-term infusion of gabexate or somatostatin did not show efficacy for either drug. CONCLUSIONS: Short-term administration of gabexate or somatostatin in patients at high risk for pancreatitis is ineffective for prevention of ERCP-induced pancreatitis. Pancreatic injury is related to maneuvers used to obtain biliary access rather than to any patient characteristic or endoscopist experience.
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