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2.
Front Med (Lausanne) ; 9: 868449, 2022.
Article in English | MEDLINE | ID: mdl-35463020

ABSTRACT

Background: The quality of gastrointestinal (GI) endoscopy has been recently identified as a major priority being associated with many outcomes and patient's experience. Objective: To assess adherence of endoscopists to the European Society of Gastrointestinal Endoscopy (ESGE) quality performance measures for upper and lower GI endoscopy in Italy. Methods: All endoscopist members of the Italian Society of Digestive Endoscopy (SIED) were invited from October 2018 to December 2018 to participate to a self-administered questionnaire-based survey. The questionnaire included questions on demographics and professional characteristics, and the recent ESGE quality performance measures for upper and lower GI endoscopy. Results: A total of 392 endoscopists participated in the study. Only a minority (18.2%) of participants recorded the duration of esophagogastroduodenoscopy (EGD) and 51% provided accurate photo documentation in the minimum standard of 90% of cases. Almost all endoscopists correctly used Prague and Los Angeles classifications (87.8% and 98.2%, respectively), as well as Seattle and Management of precancerous conditions and lesions in the stomach (MAPS) biopsy protocols (86.5% and 91.4%, respectively). However, only 52.8% of participants monitored complications after therapeutic EGD, and 40.8% recorded patients with a diagnosis of Barrett's esophagus (BE). With regard to colonoscopy, almost all endoscopists (93.9%) used the Boston Bowel Preparation Scale for measuring bowel preparation quality and reported a cecal intubation rate ≥90%. However, about a quarter (26.2%) of participants reported an adenoma detection rate of <25%, only 52.8% applied an appropriate polypectomy technique, 48% monitored complications after the procedure, and 12.4% measured patient's experience. Conclusion: The adherence of endoscopists to ESGE performance measures for GI endoscopy is sub-optimal in Italy. There is a need to disseminate and implement performance measures and endorse educational and scientific interventions on the quality of endoscopy.

3.
Endosc Int Open ; 9(11): E1627-E1632, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34790524

ABSTRACT

Background and study aims Endoscope reprocessing has been associated with a variable failure rate. Our aim was to present an overview on current practices for reprocessing in Italian facilities and discuss the principle critical points. Methods In 2014 the Italian Society for Digestive Diseases implemented an accreditation program in collaboration with an independent organization for certification and with the Italian Association for Endoscopy Technical Operators. During a 1-day site visit of the endoscopy center, two endoscopists, one nurse, and the representative of the certification body evaluated the endoscope reprocessing. Results As of July 1, 2020, 28 endoscopy centers had been accredited. Ten centers are completing the measures to correct deficiencies found at the visit. Three centers withdrew from the program. The accreditation program has found variations between the various centers, confirming the poor compliance with guidelines. Major deviations from the standards, established by the model before the site visit according to national and international guidelines, concerned instrument cleaning (44.7 % of the centers), instrument storage (23.7 %), and microbiological tests (31.6 %). Conclusions Our overview demonstrated the lack of many reprocessing phases, which are important to prevent endoscopy-associated infections. Accreditation can achieve a transformation in quality and safety of reprocessing with the Italian centrally-led approach.

4.
Expert Rev Gastroenterol Hepatol ; 15(1): 1-4, 2021 Jan.
Article in English | MEDLINE | ID: mdl-32866408

ABSTRACT

INTRODUCTION: Accreditation is one method of assuring quality, but the evidence base in support of service accreditation is mixed. More recent experiences indicate that accreditation may accelerate improvements. AREAS COVERED: Our aim is focused on endoscopy service accreditation and we conducted a literature search using Medline (via Pubmed) and the Cochrane Center Register of Controlled Trials up to January 2020. EXPERT OPINION: Worldwide numerous centers fail to meet important quality indicators as suggested by international guidelines. Accreditation can provide means for detecting many problems and correcting them by implementing agreed standards.


Subject(s)
Accreditation , Endoscopy, Digestive System/standards , Quality Assurance, Health Care/standards , Accreditation/standards , Guideline Adherence , Humans , Practice Guidelines as Topic , Quality Improvement/standards , Quality Indicators, Health Care/standards
5.
Endosc Int Open ; 8(3): E338-E345, 2020 Mar.
Article in English | MEDLINE | ID: mdl-32140556

ABSTRACT

Background and study aims Accreditation of endoscopy services, using valid quality indicators, may address failures to comply with quality standards between endoscopy services. The aim of this work was to present the Italian Society for Digestive Endoscopy (SIED) accreditation model and its effectiveness. Methods A team of eight endoscopists identified quality indicators derived from international guidelines and assessed them in each center voluntarily requesting accreditation. During a 1-day site visit, two expert endoscopists, the representative of the independent and international administrative certification body and a professional nurse evaluated the endoscopy center, by direct observation of the endoscopy team and examination of the medical records Results In all centers we noted shortcomings in instrument reprocessing. In 30 of 40 centers (75 %) the information in the nursing charts was incomplete. Sampling for Helicobacter pylori had not been done in 12 of 40 centers (30 %). In six of 40 centers (15 %) the adenoma detection rate for each endoscopist had not been evaluated. Post-polypectomy intervals were inappropriate in 12 of 40 centers (30 %). We noted a statistically significant difference ( P  < 0.001) between the answers to the SIED checklist of indicators submitted to the inspection team for accreditation before the site visit and the situation found for colonoscopy on site. As of June 30, 2018, 18 endoscopy centers had been accredited and 10 centers had not yet being accredited because they had not completed the measures to correct points raised at the visits. Conclusions Numerous Italian endoscopy centers fail to meet important quality indicators. Our accreditation program can provide means for detecting these problems and correcting them by implementing SIED standards.

6.
Frontline Gastroenterol ; 10(2): 112-154, 2019 Apr.
Article in English | MEDLINE | ID: mdl-31205649

ABSTRACT

We present an uncommon case of a patient presenting at the emergency department for severe vomiting, persisting for at least 12 hours, without nausea or abdominal pain. She initially referred vomiting food eaten several hours earlier and eventually a single episode of haematemesis with emission of a small amount of red blood and clots. She also reported the occurrence of acute dysphagia for solid food. The patient underwent oesophagogastroduodenoscopy (OGD), which showed that the lumen was almost completely narrowed by a submucosal bluish bulging from midoesophagus (19 cm from the incisors) to the cardia (located at 35 cm from the incisors). She therefore underwent chest CT showing a 15 cm long intramural oesophageal haematoma. Although the combination of vomiting and haematemesis is usually associated with Mallory-Weiss syndrome, in which a prompt OGD has a key role in the patient management, when these symptoms are associated with acute dysphagia, a possible intramural haematoma might be suspected. In this case, chest CT should take precedence, because it allows a quick and complete diagnostic appraisal. However, in this setting, although OGD can directly show typical findings (bluish swelling mucosa with or without a superficial tears), it might increase the risk of oesophageal haematoma rupture and intraluminal bleeding.

7.
Gastrointest Endosc ; 89(3): 554-564.e1, 2019 03.
Article in English | MEDLINE | ID: mdl-30273590

ABSTRACT

BACKGROUND AND AIMS: Blue-light imaging (BLI) is a new chromoendoscopy technique, potentially useful for differentiating neoplastic from nonneoplastic lesions. The present study was aimed at comparing BLI with high-definition white light (HDWL) in the real-time histology prediction of colon polyps <10 mm. METHODS: Consecutive outpatients undergoing colonoscopy with the ELUXEO 7000 endoscopy platform and 760 series video colonoscopes (Fujifilm Co, Tokyo, Japan) who had at least 1 polyp <10 mm were randomized to BLI or HDWL for polyp characterization. The accuracy of high-confidence real-time histology prediction (adenoma vs not adenoma) by either BLI or HDWL for polyps <10 mm (primary end-point) and diminutive (≤5 mm) polyps was calculated, along with sensitivity, specificity, and positive and negative predictive values, with histopathology as the reference standard. RESULTS: A total of 483 polyps were detected in 245 randomized patients (125 and 120 in the BLI and HDWL arms, respectively). A total of 358 were diminutive, and 283 were adenomas. Overall, 222 (85.7%) and 193 (86.1%) polyps were characterized with high confidence by BLI and HDWL, respectively (P = .887), with an overall accuracy of 92% and 84%, respectively (P = .011). The accuracy was significantly higher by BLI than HDWL, also for diminutive polyps (92% vs 83%; P = .008). When BLI was used, the negative predictive value for diminutive rectosigmoid polyps was 88%, and the post-polypectomy surveillance interval was correctly attributed in 85.7% and 93.7% of patients, respectively, according to U.S. and European guidelines. CONCLUSION: BLI was superior to HDWL for the real-time prediction of histology in polyps <10 mm. A BLI-dedicated classification might further improve the endoscopist performance. (Clinical trial registration number: NCT03274115.).


Subject(s)
Adenomatous Polyps/pathology , Colonic Polyps/pathology , Colonoscopy/methods , Colorectal Neoplasms/pathology , Narrow Band Imaging/methods , Adenomatous Polyps/diagnosis , Aged , Colonic Polyps/diagnosis , Colorectal Neoplasms/diagnosis , Female , Humans , Intestinal Polyps/diagnosis , Intestinal Polyps/pathology , Male , Middle Aged , Sensitivity and Specificity , Tumor Burden
9.
Endoscopy ; 50(4): 396-402, 2018 04.
Article in English | MEDLINE | ID: mdl-29539651

ABSTRACT

BACKGROUND: Linked color imaging (LCI) is a newly developed image-enhancing endoscopy technology that provides bright endoscopic images and increases color contrast. We investigated whether LCI improves the detection of neoplastic lesions in the right colon when compared with high definition white-light imaging (WLI). METHODS: Consecutive patients undergoing colonoscopy were randomized (1:1) after cecal intubation into right colon inspection at first pass by LCI or by WLI. At the hepatic flexure, the scope was reintroduced to the cecum under LCI and a second right colon inspection was performed under WLI in previously LCI-scoped patients (LCI-WLI group) and vice versa (WLI-LCI group). Lesions detected on first- and second-pass examinations were used to calculate detection and miss rates, respectively. The primary outcome was the right colon adenoma miss rate. RESULTS: Of the 600 patients enrolled, 142 had at least one adenoma in the right colon, with similar right colon adenoma detection rates (r-ADR) in the two groups (22.7 % in LCI-WLI and 24.7 % in WLI-LCI). At per-polyp analysis, double inspection of the right colon in the LCI-WLI and WLI-LCI groups resulted in an 11.8 % and 30.6 % adenoma miss rate, respectively (P < 0.001). No significant difference in miss rate was found for advanced adenomas or sessile serrated lesions. At per-patient analysis, at least one adenoma was identified in the second pass only (incremental ADR) in 2 of 300 patients (0.7 %) in the LCI - WLI group and in 13 of 300 patients (4.3 %) in the WLI - LCI group (P = 0.01). CONCLUSIONS: LCI could reduce the miss rate of neoplastic lesions in the right colon.


Subject(s)
Adenoma/diagnostic imaging , Colon, Ascending/diagnostic imaging , Colon, Transverse/diagnostic imaging , Colonic Neoplasms/diagnostic imaging , Colonic Polyps/diagnostic imaging , Colonoscopy , Image Enhancement/methods , Aged , Color , Diagnostic Errors , Female , Humans , Male , Middle Aged , Prospective Studies
10.
United European Gastroenterol J ; 6(2): 283-289, 2018 Mar.
Article in English | MEDLINE | ID: mdl-29511558

ABSTRACT

BACKGROUND: A split-dose (SD) regimen is crucial for colonoscopy quality. Compliance with SD for early morning colonoscopy is generally poor. The present study evaluated whether pre-colonoscopy counselling, in addition to a dedicated leaflet, might increase SD uptake. METHODS: Consecutive 50-69-year-old patients undergoing screening colonoscopy before 10 a.m. were randomized to either receive written information only on bowel preparation (Written Group, WG) or written and oral instructions (Written and Oral Group, WaOG). The leaflet strongly encouraged SD adoption. The primary endpoint was the number of patients adopting SD in each group. The secondary endpoints were predictors of SD uptake, compliance with preparation schemes and cleansing adequacy. RESULTS: A total of 286 patients (143 WG, 143 WaOG) were enrolled (mean age 59.6 ± 6.1 years, men 49.3%). SD was adopted by 114 and 125 patients in the WG and WaOG, respectively (79.7% versus 87.4%, p = 0.079). No significant differences were observed for the proportion of patients with full compliance with preparation scheme (97.9% versus 97.2%, p = 0.99) and of procedures with adequate bowel cleansing (95.6% versus 95.1%, p = 0.77). At multivariate analysis, a > 1 h travel time to the endoscopy service was inversely correlated with SD uptake (odds ratio (OR) 0.30, 95% confidence interval (CI) 0.09-0.98). CONCLUSIONS: Our leaflet guaranteed satisfactory uptake of SD and excellent adherence to the preparation scheme for early morning colonoscopy. Its use might marginalize the need for additional oral instructions, particularly in open-access settings.

11.
J Hepatol ; 66(4): 711-717, 2017 04.
Article in English | MEDLINE | ID: mdl-27965158

ABSTRACT

BACKGROUND & AIMS: Sofosbuvir (SOF) and weight-based ribarivin (RBV) represented until recently the standard of care in hepatitis C virus (HCV) genotype (GT)2 patients. In registration studies 12-16weeks duration were associated with a 90% sustained virological response at 12weeks (SVR12). Real life cohorts showed lower SVR12 rates. METHODS: SVR12 rates attained in an Italian real life cohort and possible benefits of a duration extended up to 20weeks was investigated in HCV GT2 patients with cirrhosis. The role of 2k/1b chimeras as potential predictor of treatment failure was also analysed. RESULTS: Overall, 291 HCV GT2 infected patients with bridging fibrosis or cirrhosis were evaluated. Median age was 68years (18-87); 163 were treatment naïve. Of 168 cirrhotic patients, 149 had Child-Pugh score A and 19 B, 50 platelets count <100,000/mm3 and 62 albumin <3.5g/dl. SVR12 were 95.53% overall, with 99.15% in non-cirrhotic patients and 93.06% in cirrhotic patients. In patients who completed treatment, SVR rates for cirrhotic patients resulted in 94.51%, and 94.94% after 16 or 20weeks respectively. Predictors of SVR were low platelet count and esophageal varices (OR 7.2; 95% CI 1.67-31.25; p=0.0022 and OR 0.1; 95% CI 0.01-0.72; p=0.0079, respectively). Anemia was mild in 12.4%, moderate in 3.4%, and severe in 2.4% of cases. Anemia was slightly more frequent among longer duration but not associated with treatment discontinuations. No 2k/1b strains or genotypes different from those at baseline were identified at relapse. CONCLUSIONS: In GT2 cirrhotic patients, SOF/RBV for 16 or 20weeks is associated with real life SVR12 rates of 95%. LAY SUMMARY: A duration of treatment of 16-20weeks was recommended for treatment of HCV GT2 patients using the combination of sofosbuvir and ribavirin. Real life experiences, where patients received 12weeks of treatment regardless of the severity of liver disease, suggested that response rates are lower than expected, in particular in patients with liver cirrhosis. A misleading genotyping of a 2k/1b strain as GT2 was also hypothesized as a further explanation for less effectiveness. We demonstrated that using the recommended extended duration in patients with more severe disease 95% of patients with severe liver disease including cirrhosis can be cured and that 2k/1b strain plays only a secondary role in specific countries like Germany. Although this combination has been recently replaced by sofosbuvir and velpatasvir fixed dose combination as the standard of care for treating HCV GT2 patients, our findings may inform physicians from countries where the new regimen is not yet available.


Subject(s)
Antiviral Agents/administration & dosage , Hepacivirus/genetics , Hepatitis C, Chronic/drug therapy , Ribavirin/administration & dosage , Sofosbuvir/administration & dosage , Adolescent , Adult , Aged , Aged, 80 and over , Cohort Studies , Drug Administration Schedule , Drug Therapy, Combination , Female , Genotype , Hepacivirus/classification , Hepatitis C, Chronic/complications , Hepatitis C, Chronic/virology , Humans , Italy , Liver Cirrhosis/complications , Male , Middle Aged , Prospective Studies , RNA, Viral/blood , RNA, Viral/genetics , Recombination, Genetic , Sustained Virologic Response , Treatment Failure , Young Adult
12.
Expert Rev Gastroenterol Hepatol ; 10(12): 1349-1358, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27701933

ABSTRACT

INTRODUCTION: Adenoma detection rate (ADR) is the most robust colonoscopy quality metric and clinical studies have adopted it as the ideal method to assess the impact of technical interventions. Areas covered: We reviewed papers focusing on the impact of colonoscopy technical issues on ADR, including withdrawal time and technique, second evaluation of the right colon, patient positional changes, gastrointestinal assistant participation during colonoscopy, water-aided technique, optimization of bowel preparation and antispasmodic administration. Expert commentary: Overall, technical interventions are inexpensive, available worldwide and easy to implement. Some of them, such as the adoption of split dose regimen and slow scope withdrawal to allow a careful inspection, have been demonstrated to significantly improve ADR. Emerging data support the use of water-exchange colonoscopy. According to published studies, other technical interventions seem to provide only marginal benefit to ADR. Unfortunately, the available evidence has methodological limitations, such as small sample sizes, the inclusion of expert endoscopists only and the evaluation of single technical interventions. Additionally, larger studies are needed to clarify whether these interventions might have a higher benefit on low adenoma detectors and whether the implementation of a bundle of them, instead of a single technical maneuver, might have a greater impact on ADR.


Subject(s)
Adenoma/pathology , Colonic Neoplasms/pathology , Colonoscopy/methods , Cathartics/administration & dosage , Humans , Parasympatholytics/administration & dosage , Patient Positioning , Predictive Value of Tests , Reproducibility of Results , Therapeutic Irrigation , Time Factors
13.
United European Gastroenterol J ; 4(4): 595-8, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27536370

ABSTRACT

BACKGROUND: Underwater endoscopic mucosal resection without submucosal injection has been described for removing large flat colorectal lesions. OBJECTIVE: We aim to evaluate the reproducibility of this technique in terms of ease of implementation, safety and efficacy. METHODS: A prospective observational study of consecutive underwater endoscopic mucosal resection in a community hospital was performed. RESULTS: From September 2014 to April 2015, 25 flat or sessile colorectal lesions (median size 22.8 mm, range 10-50 mm; 18 placed in the right colon) were removed in 25 patients. Two of the lesions were adenomatous recurrences on scar of prior resection and one was a recurrence on a surgical anastomosis. The resection was performed en bloc in 76% of the cases. At the pathological examination, 14 lesions (56%) had advanced histology and seven (28%) were sessile serrated adenomas (two with high-grade dysplasia). Complete resection was observed in all the lesions removed en bloc. Intra-procedural bleeding was observed in two cases; both were managed endoscopically and were uneventful. No major adverse events occurred. CONCLUSION: Underwater endoscopic mucosal resection appears to be an easy, safe and effective technique in a community setting. Further studies evaluating the efficacy of the technique (early and late recurrence), as well as comparing it with traditional mucosal resection, are warranted.

15.
Endosc Int Open ; 3(5): E464-70, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26528503

ABSTRACT

BACKGROUND: The guidewire biliary cannulation (GWC) technique may increase the cannulation rate and decrease the risk for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. The aim of our multicenter prospective randomized controlled trial was to determine if the use of an atraumatic loop-tip guidewire reduces the rate of post-ERCP pancreatitis (PEP) compared with the standard contrast-assisted cannulation (CC) technique. METHODS: From June 2012 to December 2013, a total of 320 patients who had a naïve papilla and were referred for ERCP were randomly assigned to the GWC group (n = 160) or the CC group (n = 160). GWC or CC was randomly used. In cases of failed cannulation in both arms after crossover, biliary access was attempted with alternative techniques (e. g., dual-wire technique, pancreatic duct stenting, precut). RESULTS: The biliary cannulation rates were 81 % in the GWC group and 73 % in the CC group (P = n. s.). Following crossover, cannulation was successful in 8 % and 11 % of patients in the GWC and CC groups, respectively. With use of an alternative technique, the cannulation rates were 98 % in the GWC group and 96 % in the CC group, respectively. The rates of PEP were 5 % in the GWC group and 12 % in the CC group (P = 0.027). The post-interventional complication rates did not differ between the two groups. CONCLUSION: GWC with the new wire guide is associated with a lower rate of PEP in comparison with the CC technique. Clinical trial reference number: NCT01771419.

16.
Dig Liver Dis ; 47(10): 857-63, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26232311

ABSTRACT

BACKGROUND: Chronic constipation is a risk factor of inadequate bowel preparation for colonoscopy; however, no large clinical trials have been performed in this subgroup of patients. AIMS: To compare bowel cleansing efficacy, tolerability and acceptability of 2-L polyethylene-glycol-citrate-simethicone (PEG-CS) plus 2-day bisacodyl (reinforced regimen) vs. 4-L PEG in patients with chronic constipation undergoing colonoscopy. METHODS: Randomized, observer-blind, parallel group study. Adult outpatients undergoing colonoscopy were randomly allocated to 2-L PEG-CS/bisacodyl or 4-L PEG, taken as split regimens before colonoscopy. Quality of bowel preparation was assessed by the Ottawa Bowel Cleansing Scale (OBCS). The amount of foam/bubble interfering with colonic visualization was also measured. RESULTS: 400 patients were enrolled. There was no significant difference in successful cleansing (OBCS score ≤6): 80.2% in the 2-L PEG-CS/bisacodyl vs. 81.4% in the 4-L PEG group. Significantly more patients taking 2L PEG-CS/bisacodyl showed no or minimal foam/bubbles in all colonic segments (80% vs. 63%; p<0.001). 2-L PEG-CS/bisacodyl was significantly more acceptable for ease of administration (p<0.001), willingness to repeat (p<0.001) and showed better compliance (p=0.002). CONCLUSION: Split 2-L PEG-CS plus bisacodyl was not superior to split 4-L PEG for colonoscopy bowel cleansing in patients with chronic constipation; however, it performed better than the standard regimen in terms of colonic mucosa visualization, patient acceptance and compliance.


Subject(s)
Bisacodyl/administration & dosage , Cathartics/administration & dosage , Colon/drug effects , Colonoscopy/standards , Constipation/drug therapy , Polyethylene Glycols/administration & dosage , Aged , Cathartics/adverse effects , Chronic Disease , Citric Acid/administration & dosage , Female , Humans , Italy , Male , Middle Aged , Patient Compliance , Simethicone/administration & dosage
17.
Endoscopy ; 47(9): 808-14, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26070008

ABSTRACT

BACKGROUND AND STUDY AIMS: It has been proposed that the use of narrow-band imaging (NBI) for real-time histological assessment to determine postpolypectomy surveillance intervals is a cost-effective approach to the management of diminutive polyps. However, significant discrepancies in NBI performance have been observed among endoscopists; hence, professional societies recommend training, monitoring, and auditing. The aim of the present study was to evaluate the performance of real-time optical diagnosis for diminutive polyps after the inclusion of this approach in an internal quality assurance program, in order to assess its applicability in clinical practice Patients and methods: Four endoscopists attended periodic training sessions on NBI assessment of polyp histology before and during the study. Performance was audited and periodic feedback was provided. The accuracy of high-confidence NBI evaluation for polyps ≤ 5 mm in predicting surveillance intervals according to the European and US guidelines, and the negative predictive value (NPV) for adenoma in the rectosigmoid were calculated and compared with recommended thresholds (90 % agreement and 90 % NPV, respectively). RESULTS: Overall, 284 outpatients (mean age 61.3 ±â€Š18.2 years; 63 % males) were enrolled. A total of 656 polyps were detected, 465 of which (70.9 %) were diminutive (70.5 % adenomas). Sensitivity, specificity, positive and negative predictive values, and accuracy of high-confidence NBI predictions for adenoma in diminutive lesions were 95.3 %, 83.5 %, 93.5 %, 87.6 %, and 91.9 %, respectively. High-confidence characterization of diminutive polyps predicted the correct surveillance interval in 95.8 % and 93.3 % of cases according to European and American guidelines, respectively. NPV for adenoma in the rectosigmoid was 91.3 % CONCLUSIONS: For community settings in which endoscopists are adequately trained and performance is periodically audited, real-time optical diagnosis for diminutive polyps is sufficiently accurate to avoid postpolypectomy histological examination of resected lesions, or to leave rectosigmoid hyperplastic polyps in place. Trial registered at ClinicalTrials.gov (NCT02196402).


Subject(s)
Adenoma/diagnosis , Colonic Neoplasms/diagnosis , Colonic Polyps/diagnosis , Colonoscopy , Narrow Band Imaging , Population Surveillance , Adult , Aged , Colonic Polyps/surgery , Diagnosis, Differential , Hospitals, Community , Humans , Middle Aged , Predictive Value of Tests , Prospective Studies , Time Factors
18.
Gastrointest Endosc ; 80(6): 1103-12.e2, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25053528

ABSTRACT

BACKGROUND: Hyoscine-N-butylbromide (HBB) can induce flattening of colon folds through inhibition of smooth muscle activity, which improves mucosal visualization. Whether this affects polyp detection is controversial. OBJECTIVE: To evaluate whether HBB, administered during colonoscopy, improves polyp and adenoma detection. DESIGN: We performed a comprehensive search in MEDLINE and EMBASE databases to identify randomized, placebo-controlled trials (RCTs) in which HBB was administered during colonoscopy and which also reported the detection rate for polyps and/or adenomas (PDR and/or ADR, respectively). SETTING: Meta-analysis of 5 RCTs. PATIENTS: A total of 1998 patients (1006 receiving HBB) were included in the study. INTERVENTIONS: Intravenous administration of 20 mg (2 mL) HBB or 2 mL saline solution at the time of cecal intubation. MAIN OUTCOME MEASUREMENTS: The PDR was the primary outcome variable. Secondary outcomes included the ADR, the advanced adenoma detection rate (adv-ADR), and the mean number of polyps and adenomas per patient (PPP and APP, respectively). RESULTS: The PDR, ADR, and adv-ADR did not differ significantly between the 2 groups. The odds ratios (95% confidence interval [CI]) for PDR, ADR, and adv-ADR were 1.09, 95% CI, 0.91-1.31; 1.13, 95% CI, 0.92-1.38; and 0.9, 95% CI, 0.63-1.30, respectively. In addition, no significant differences were observed in PPP and APP between the 2 groups. LIMITATIONS: Small number of studies included. Limited data about secondary outcomes and safety. CONCLUSION: Our meta-analysis does not provide evidence that routine HBB administration at cecal intubation improves PDR or ADR. More studies are needed for final conclusions, particularly on HBB's effect on PPP and APP.


Subject(s)
Adenomatous Polyps/diagnosis , Butylscopolammonium Bromide , Colonic Neoplasms/diagnosis , Colonic Polyps/diagnosis , Colonoscopy/methods , Muscarinic Antagonists , Adenoma/diagnosis , Humans , Randomized Controlled Trials as Topic
19.
Dig Liver Dis ; 46(7): 616-20, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24721107

ABSTRACT

BACKGROUND: The two-operator technique for colonoscopy, with the endoscopy assistant actively advancing and withdrawing the scope, is still commonly practiced in Europe. As uncontrolled data has suggested that the one-operator technique is associated with a higher adenoma detection rate, we tested the hypothesis that the two-operator-technique can achieve comparable performances in terms of adenoma detection. METHODS: Non-inferiority trial in which consecutive adult outpatients were randomised to undergo colonoscopy by one (one-operator) or by four endoscopists. Each performed half the procedures by one-operator and half by two-operator technique independently of routine clinical practice. Main outcome measure was adenoma detection rate. RESULTS: 352 subjects (49% males, mean age 60 ± 12.1 years) were randomised to one (n=176) or to two-operator technique (n=176) colonoscopy. No significant differences were found in adenoma detection (33% vs. 30.7%, p=0.65), or cecal intubation rate, procedure times, and patient tolerability. No differences were found in the subgroup analysis according to routinely adopted colonoscopy technique. CONCLUSIONS: This study does not confirm a higher adenoma detection rate for one-operator technique colonoscopy. Changing current practice to improve adenoma detection rate for endoscopists routinely using two-operator technique is not warranted.


Subject(s)
Adenoma/diagnosis , Colonic Neoplasms/diagnosis , Colonoscopy/standards , Quality of Health Care , Cecum , Colonoscopy/adverse effects , Colonoscopy/methods , Female , Humans , Intubation, Gastrointestinal , Male , Memory, Episodic , Middle Aged , Operative Time , Single-Blind Method
20.
Clin Gastroenterol Hepatol ; 12(8): 1303-10, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24398064

ABSTRACT

BACKGROUND & AIMS: Computed tomographic colonography (CTC) is a reliable option for screening subjects who are unable or unwilling to undergo optical colonoscopy (OC). A colon capsule (PillCam Colon2 [CC2]; GivenImaging Ltd., Yokneam, Israel) has shown promising results in detecting polyps larger than 6 mm. We compared the accuracy of CC2 and CTC in identifying individuals with at least 1 polyp greater than 6 mm and subjects' attitude toward the procedures. METHODS: Fifty individuals (mean age, 59.2 ± 5.8 y; 58% male) with positive results from the immunochemical fecal occult blood test (iFOBT-positive) underwent CC2, CTC, and OC. The unblinded colonoscopy, integrating OC, CTC, and CC2 results, was used as the reference standard. In a per-patient analysis, the accuracy of CC2 and CTC were assessed for individuals with at least 1 polyp 6 mm or larger. Individuals were asked to choose which procedure they would be willing to repeat between CTC and CC2. RESULTS: The combination of OC, CTC, and CC2 identified 16 cases with at least 1 polyp 6 mm or larger (reference standard). CTC identified the polyps with 88.2% sensitivity, 84.8% specificity, a 3.0 positive likelihood ratio, and a 0.07 negative likelihood ratio. CC2 identified the polyps with 88.2% sensitivity, 87.8% specificity, a 3.75 positive likelihood ratio, and a 0.06 negative likelihood ratio. Thirty-nine subjects (78%) said they preferred CC2 to CTC. CONCLUSIONS: CC2 and CTC detect polyps 6 mm and larger with high levels of accuracy; these techniques are effective in selecting iFOBT-positive individuals who do not need to be referred for colonoscopy. CC2 seems to be better tolerated than CTC, and could be a reliable alternative to CTC for iFOBT-positive individuals who are unable or unwilling to undergo OC. ClinicalTrials.gov number: NCT01744509.


Subject(s)
Colon/pathology , Colonic Neoplasms/diagnosis , Colonography, Computed Tomographic/methods , Colonoscopy/methods , Occult Blood , Polyps/diagnosis , Aged , Female , Humans , Israel , Male , Middle Aged
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