Colonoscopy Satisfaction and Safety Questionnaire based on patient experience (CSSQP): A valuable quality tool for all colonoscopies.

INTRODUCTION: The Colonoscopy Satisfaction and Safety Questionnaire based on Patient experience (CSSQP) was recently developed and validated within a Bowel Cancer Screening Program. We aimed to identify factor related to patient experience through the CSSQP, including all indications for colonoscopy. Indicators of satisfaction and perceived safety with colonoscopy were also assessed to compare the different centers. METHODS: Multicenter study in nine Spanish hospitals. Consecutive patients who had undergone a colonoscopy completed the CSSQP adding a novel item on bowel preparation. Factors related to patient experiences and data from non-respondents were analyzed. RESULTS: Of 2200 patients, 1753 filled out the questionnaire (response rate 79.7%, sample error 2%). Patients whose colonoscopy indication was a primary colorectal cancer screening (OR: 1.68, 95% CI: 1.15-2.44, p=0.007) or due to a +FIT (OR: 1.73, 95% CI: 1.18-2.53) reported higher satisfaction than patients with gastrointestinal symptoms. In addition, college-educated patients (OR: 2.11, 95% CI: 1.25-3.56) were more likely to report better overall satisfaction than patients with lower education level. Significant differences were observed in the majority of the CSSQP items between centers. Safety incidents were reported by 35 (2%) patients, and 176 (10%) patients reported that they received insufficient information. CONCLUSION: The CSSQP identifies several significant factors on satisfaction and perceived safety in patients referred for colonoscopy for any reason. The CSSQP also allows comparison of patient-identified colonoscopy quality indicators between centers.

Spanish Intragastric Balloon Consensus Statement (SIBC): practical guidelines based on experience of over 20 000 cases.

BACKGROUND: intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018). OBJECTIVES: to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %. RESULTS: overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution. CONCLUSIONS: this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC.

Cuff-assisted versus cap-assisted colonoscopy for adenoma detection: results of a randomized study.

BACKGROUND: The adenoma detection rate (ADR) is the most important marker of colonoscopy quality. Devices to improve adenoma detection have been developed, such as the Endocuff and transparent cap. The aim of the current study was to examine whether there was a difference in ADR between Endocuff-assisted (EAC) and cap-assisted colonoscopy (CAC). METHODS: A randomized prospective trial was conducted. Eligible patients included adults ≥ 18 years referred because of symptoms, surveillance, or colonoscopies as part of the Bowel Cancer Screening Programme (BCSP). The primary outcome measure was ADR. Secondary outcomes included mean number of adenomas, mean number of polyps, polyp detection rate, cecal intubation rate, and time to cecal intubation. Procedural measures, device removal rate, and adverse events were also recorded. RESULTS: A total of 711 patients (51.1 % men; median age 63 years) were included, of whom 357 patients were randomized to EAC and 354 patients to CAC. In the intention-to-treat analysis, the ADR was similar in both groups: EAC 50.4 % (95 % confidence interval [CI] 45.1 - 55.7) vs. CAC 50.6 % (95 %CI 45.2 - 55.9). Similar results were obtained in the per-protocol analysis: EAC 51.6 % (95 %CI 46.2 - 57) vs. CAC 51.4 % (95 %CI 46 - 56.8). There were no differences between the two devices in ADR according to the mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation. Device removal rate and adverse events were also similar. CONCLUSION: In this randomized study, no differences in ADR were found between Endocuff- and cap-assisted colonoscopy.

The Colonoscopy Satisfaction and Safety Questionnaire (CSSQP) for Colorectal Cancer Screening: A Development and Validation Study.

Colonoscopy services working in colorectal cancer screening programs must perform periodic controls to improve the quality based on patients' experiences. However, there are no validated instruments in this setting that include the two core dimensions for optimal care: satisfaction and safety. The aim of this study was to design and validate a specific questionnaire for patients undergoing screening colonoscopy after a positive fecal occult blood test, the Colonoscopy Satisfaction and Safety Questionnaire based on patients' experience (CSSQP). The design included a review of available evidence and used focus groups to identify the relevant dimensions to produce the instrument (content validity). Face validity was analyzed involving 15 patients. Reliability and construct and empirical validity were calculated. Validation involved patients from the colorectal cancer screening program at two referral hospitals in Spain. The CSSQP version 1 consisted of 15 items. The principal components analysis of the satisfaction items isolated three factors with saturation of elements above 0.52 and with high internal consistency and split-half readability: Information, Care, and Service and Facilities features. The analysis of the safety items isolated two factors with element saturations above 0.58: Information Gaps and Safety Incidents. The CSSQP is a new valid and reliable tool for measuring patient' experiences, including satisfaction and safety perception, after a colorectal cancer screening colonoscopy.

Colonic stenting as a bridge to surgery versus emergency surgery for malignant colonic obstruction: results of a multicentre randomised controlled trial (ESCO trial).

BACKGROUND: The aim of colonic stenting with self-expandable metallic stents in neoplastic colon obstruction is to avoid emergency surgery and thus potentially reduce morbidity, mortality, and need for a stoma. Concern has been raised, however, about the effect of colonic stenting on short-term complications and long-term survival. We compared morbidity rates after colonic stenting as a bridge to surgery (SBTS) versus emergency surgery (ES) in the management of left-sided malignant large-bowel obstruction. METHODS: This multicentre randomised controlled trial was designed with the endorsement of the European Association for Endoscopic Surgery. The study population was consecutive patients with acute, symptomatic malignant left-sided large-bowel obstruction localised between the splenic flexure and 15 cm from the anal margin. The primary outcome was overall morbidity within 60 days after surgery. RESULTS: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 29/144 (13.9%) were excluded post-randomisation mainly because of wrong diagnosis at computed tomography examination. The remaining 115 patients (SBTS n = 56, ES n = 59) were deemed eligible for analysis. The complications rate within 60 days was 51.8% in the SBTS group and 57.6% in the ES group (p = 0.529). Although long-term follow-up is still ongoing, no statistically significant difference in 3-year overall survival (p = 0.998) and progression-free survival rates between the groups has been observed (p = 0.893). Eleven patients in the SBTS group and 23 in the ES group received a stoma (p = 0.031), with a reversal rate of 30% so far. CONCLUSIONS: Our findings indicate that the two treatment strategies are equivalent. No difference in oncologic outcome was found at a median follow-up of 36 months. The significantly lower stoma rate noted in the SBTS group argues in favour of the SBTS procedure when performed in expert hands.

Accuracy for optical diagnosis of colorectal polyps in clinical practice.

BACKGROUND: Optical diagnostic involves predicting polyp histopathology from its endoscopic characteristics. It is only recommended for diminutive polyps ( < or = 5 mm) and for predictions made with high confidence. OBJECTIVES: To evaluate the accuracy of optical imaging in clinical practice and to assess if optical diagnosis is useful for predicting future colonoscopy surveillance intervals without waiting for histopathological analysis. METHODS: consecutive > 18 years patients were enrolled in this prospective study. Colonoscopies were performed by five expert endoscopists who previously participated in an ex-vivo training. Colonoscopes CF-H180AL and CF-Q180AL were used together with Exera II (Olympus Medical System, Tokyo, Japan) processors. Each polyp was characterized in real time using white light and Narrow Band Imaging. Accuracy of optical diagnosis (S, E, NPV, PPV) and correlation between surveillance interval based on optical diagnosis and histopathological analysis were calculated. RESULTS: 311 colon polyps < 10 mm (216 diminutive) in 195 patients were analyzed. Accuracy of optical diagnostics for predictions made with high confidence: Diminutive polyps(sensitivity 0.59, specificity 0.92, NPV 0.48); polyps < 10 mm (sensitivity 0.73, specificity 0.88, NPV 0.50). An optical diagnosis based surveillance recommendation was given to 90 patients. Concordance with histopathology based recommendation was 92.2% according to the European guideline and 93.3% according to the ESGE guideline. CONCLUSIONS: Optical diagnostics can be used to predict future surveillance intervals immediately after colonoscopy. However, in this study, based on clinical practice, the accuracy of optical imaging is below the recommended standards.

Tumor regression and survival after perioperative MAGIC-style chemotherapy in carcinoma of the stomach and gastroesophageal junction.

BACKGROUND: We assessed the effectiveness of perioperative MAGIC-style chemotherapy in our series focused on the tumor regression grade and survival rate. METHODS: We conducted a retrospective study of 53 patients following a perioperative regimen of epirubicin, cisplatin, and fluorouracil or capecitabine (ECF/X). Forty-four (83 %) neoplasias were located in the stomach and 9 (17 %) were located at the esophagogastric junction. Perioperative chemotherapy completion, resection, TNM staging, the tumor regression grade (Becker's classification) and survival were analyzed. RESULTS: Forty-five patients (85 %) completed the 3 preoperative cycles. R0 resection was achieved in 42 (79 %) patients. Thirty-five (66 %) patients completed the 3 postoperative cycles. Nine carcinomas (17 %) were considered major responders after preoperative chemotherapy. With multivariate analysis, only completion of perioperative chemotherapy (HR: 0.25; 95%CI: 0.08 - 0.79; p = 0.019) was identified as an independent prognostic factor for disease-specific survival. However, the protective effect of perioperative therapy was lost in patients with ypT3-4 and more than 4 positive lymph nodes (HR: 1.16; 95%CI: 1.02 - 1.32; p = 0.029). The tumor regression grade (major vs minor responders) was at the limit of significance only with univariate analysis. The 5-year overall and disease-specific survival rates were 18 % and 22 % respectively. CONCLUSIONS: The percentage of major responder tumors after preoperative chemotherapy was low. Completion of perioperative ECF/X chemotherapy may benefit patients with gastric carcinomas that do not invade the subserosa with few positive lymph nodes.

Relationship between tobacco, cagA and vacA i1 virulence factors and bacterial load in patients infected by Helicobacter pylori.

BACKGROUND AND AIM: Several biological and epidemiological studies support a relationship between smoking and Helicobacter pylori (H. pylori) to increase the risk of pathology. However, there have been few studies on the potential synergistic association between specific cagA and vacA virulence factors and smoking in patients infected by Helicobacter pylori. We studied the relationship between smoking and cagA, vacA i1 virulence factors and bacterial load in H. pylori infected patients. METHODS: Biopsies of the gastric corpus and antrum from 155 consecutive patients in whom there was clinical suspicion of infection by H. pylori were processed. In 106 patients H. pylori infection was detected. Molecular methods were used to quantify the number of microorganisms and presence of cagA and vacA i1 genes. A standardized questionnaire was used to obtain patients' clinical data and lifestyle variables, including tobacco and alcohol consumption. Adjusted Odds Ratios (ORadjusted) were estimated by unconditional logistic regression. RESULTS: cagA was significantly associated with active-smoking at endoscope: ORadjusted 4.52. Evidence of association was found for vacA i1 (ORadjusted 3.15). Bacterial load was higher in active-smokers, although these differences did not yield statistical significance (median of 262.2 versus 79.4 copies of H. pylori per cell). CONCLUSIONS: The association between smoking and a higher risk of being infected by a virulent bacterial population and with higher bacterial load, support a complex interaction between H. pylori infection and environmental factors.

Laparoscopic sleeve gastrectomy with endoscopic versus bougie calibration: results of a prospective study.

INTRODUCTION: The use of the endoscope for the calibration of the gastric sleeve, instead of the standard use of the bougie, is a safe procedure and gives the surgeon a higher sense of security. The aim of this study was to evaluate the effect of the use of endoscopic guidance on postoperative complications and mid-term results of the bariatric procedure. PATIENTS AND METHODS: A prospective, nonrandomized study was performed at the General University Hospital of Elche (Alicante, Spain) between 2010 and 2013. The patients were divided into the bougie calibration group and the endoscopic calibration group. The decision of which method to use depended on the availability of an endoscopist at the time of the surgery. RESULTS: Fifty patients were included in the study, 44 females (88%) and 6 males (12%), with a mean age of 43.3 years and a preoperative mean body mass index of 50.6 kg/m(2). In the endoscopic calibration group, a bleeding point in the staple line was detected and sclerosed with adrenaline in 1 patient. In the bougie calibration group there were no cases of postoperative digestive bleeding. The intraoperative tightness check with blue dye and air insufflation through an orogastric tube in the bougie calibration group was negative in all the patients. In the endoscopic calibration group the check with blue dye was also negative in all cases, but the second test with air detected the exit of air bubbles in 1 case. There were no significant differences in the operation time between groups. A significant reduction in the major complications rate was observed in the endoscopic calibration group (odds ratio=0.9; P=.034). CONCLUSIONS: Endoscopic calibration is associated with lower postoperative complications after laparoscopic sleeve gastrectomy.

Factors related to the effectiveness of variable stiffness colonoscope: results of a multivariate analysis.

BACKGROUND: Various studies and two meta-analysis have shown that a variable stiffness colonoscope improves cecal intubation rate. However, there are few studies on how this colonoscope should be used. OBJECTIVE: The aim of this study was to identify factors related to the advancement of the colonoscope when the variable stiffness function is activated. METHODS: Prospective study enrolling consecutive patients referred for colonoscopy. The variable stiffness colonoscope (Olympus CF-H180DI/L®) was used. We performed univariate and multivariate analyses of factors associated with the success of the variable stiffness function. RESULTS: After the data inclusion period, 260 patients were analyzed. The variable stiffness function was used most in the proximal colon segments (ascending and transverse colon 85%; descending/sigmoid colon 15.2%). The body mass index was lower in patients in whom the endoscope advanced after activating the variable stiffness than those in which it could not be advanced (25.9 + or - 4.8 vs. 28.3 + or - 5.4 kg/m2, p = 0.009). The endoscope advanced less frequently when the stiffness function was activated in the ascending colon versus activation in other segments of the colon (25% vs. 64.5% ascending colon vs. other segments; p < 0.05). In the multivariate analysis, only the colon segment in which the variable stiffness was activated was an independent predictor of advancement of the colonoscope. CONCLUSIONS: The variable stiffness function is effective, allowing the colonoscope advancement especially when applied in the transverse colon, descending colon and sigmoid. However, when used in the ascending colon it has a lower effectiveness.

Direct peroral cholangioscopy using an ultrathin endoscope: making technique easier.

BACKGROUND: Cholangioscopy is a useful tool for the study and treatment of biliary pathology. Ultrathin upper endoscopes allow direct peroral cholangioscopy (DPC) but have some drawbacks. OBJECTIVE: The aim of the study was to evaluate the success rate of DPC with an ultrathin endoscope using a balloon catheter to reach the biliary confluence. MATERIAL AND METHODS: Prospective observational study. An ultrathin endoscope (Olympus XP180N, outer diameter 5.5 mm, working channel 2 mm) was used. To access the biliary tree, free-hand technique was used. To reach the biliary confluence an intraductal balloon catheter (Olympus B5-2Q diameter 1.9 mm) and a 0.025 inch guide wire was used. In all cases sphincterotomy and/or sphincteroplasty was performed. The success rate was defined as the percentage of cases in which the biliary confluence could be reached with the ultrathin endoscope. RESULTS: Fifteen patients (8 men/7 women) were included. Mean age was 77.7 + or - 10.8 years (range 45-91). The indications for cholangioscopy were suspected bile duct stones (n = 9), electrohydraulic lithotripsy for the treatment of difficult choledocholithiasis (n = 5) and evaluation of biliary stricture (n = 1). Access to the bile duct was achieved in 14/15 cases (93.3%). Biliary confluence was reached in 13/15 cases (86.7%). One complication was observed in one patient (oxigen desaturation). CONCLUSIONS: DPC with an ultrathin endoscope can be done with the free-hand technique. Intraductal balloon-guided DPC allows full examination of the common bile duct in most cases.

Does "responsive insertion technology" improve practice of colonoscopy? Results of a randomized study.

OBJECTIVE. During colonoscopy, advancing the endoscope can sometimes be difficult due to the appearance of loops or bends in the insertion tube. Therefore, research continues toward improving colonoscope technology. The aim of this study is to compare the use of colonoscopes equipped with "responsive insertion technology" (RIT) versus regular non-RIT colonoscopes. MATERIALS AND METHODS. Prospective, comparative and randomized trials that included patients submitted to colonoscopy. In group I, RIT colonoscopes were used, while in group II, colonoscopies with variable stiffness but without the other components of the RIT technology were used. Demographic variables and variables related to colonoscopy, as well as the pain perceived by the patient and the difficulty in performing endoscopy were recorded. RESULTS. A total of 122 patients were included in group I and 120 patients in group II. The cecal intubation rate was similar in both groups. The use of the RIT colonoscopes was associated with a lower cecal intubation time (4.4 ± 2.0 vs. 5.4 ± 3.5, p = 0.005) and a lower difficulty in performing examinations for both the endoscopist (19.1 ± 20.0 vs. 27.7 ± 22.2, p = 0.002) and the nursing staff (20.8 ± 17.0 vs. 26.3 ± 19.6, p = 0.04). No significant differences were found between both groups in the need for ancillary maneuvers or in the pain perceived by the patient. CONCLUSIONS. RIT colonoscopes allow cecal intubation in a shorter time compared to variable stiffness colonoscopes, and are associated with a greater level of ease of the procedure.

Quantification of Helicobacter pylori in gastric mucosa by real-time polymerase chain reaction: comparison with traditional diagnostic methods.

The aim of this study was to determine the main diagnostic validity parameters of a quantitative real-time polymerase chain reaction (PCR) system for detecting Helicobacter pylori in gastric biopsies. Prospective study. The real-time PCR has an internal control for eliminating the false negatives. Our system has a good diagnostic capacity compared with the gold standard and was superior in antral mucosa: area under the curve was 0.91 for antrum (95% confidence interval [CI] 0.87 to 0.96) and 0.83 for corpus (95% CI 0.77 to 0.9). The optimum cut-off point was 3.56 microorganisms/cell for antrum (sensitivity 83.5% [95% CI 74.2 to 89.9]; specificity 91.3% [95% CI 82.3 to 96.0]; positive predictive value 92.2%; negative predictive value 81.8%). The positive likelihood ratios were 9.61 and 8.52 for antrum and corpus, respectively. With the cut-off point that maximises the Youden index, 8.7% false positives were obtained. Our methodology is useful for diagnosing infection due to H. pylori and the false positives detected probably correspond to patients who were actually infected but the infection was not detected by traditional techniques. The clinical importance of these cases should be studied in greater detail since they may involve colonisations unrelated to the patient's digestive pathology.

Real-time PCR for diagnosing Helicobacter pylori infection in patients with upper gastrointestinal bleeding: comparison with other classical diagnostic methods.

The aim of this study was to determine the diagnostic usefulness of quantification of the H. pylori genome in detection of infection in patients with upper gastrointestinal bleeding (UGB). A total of 158 consecutive patients with digestive disorders, 80 of whom had clinical presentation of UGB, were studied. The number of microorganisms was quantified using a real-time PCR system which amplifies the urease gene with an internal control for eliminating the false negatives. A biopsy sample from the antrum and corpus of each patient was processed. The rapid urease test, culture, histological study, stool antigen test, and breath test were done. The gold standard was a positive culture or positive results in at least two of the other techniques. When a positive result was defined as any number of microorganisms/human cell, the sensitivity of real-time PCR was greater in bleeding patients, especially in the gastric corpus: 68.4% (95% confidence interval [CI], 52.3 to 84.5%) in non-UGB patients versus 91.5% (95% CI, 79.6 to 97.6%) in UGB patients. When a positive result was defined as a number of microorganisms/human cell above the optimal value that maximizes the Youden index (>3.56 microorganisms/human cell in the antrum and >2.69 in the corpus), the sensitivity and specificity in UGB patients were over 80% in both antrum and corpus. Our findings suggest that some bleeding patients with infection caused by H. pylori may not be correctly diagnosed by classical methods, and such patients could benefit from the improved diagnosis provided by real-time PCR. However, the clinical significance of a small number of microorganisms in patients with negative results in classical tests should be evaluated.

Does the use of a variable stiffness colonoscope offer advantages during colonoscopy under deep sedation? Results of a randomized trial.

INTRODUCTION: Variable stiffness colonoscope may be useful in performing colonoscopies in nonsedated patients or under endoscopist-controlled sedation. The objective of this study is to evaluate whether this instrument facilitates colonoscopy in patients under deep sedation monitored by an anaesthesiologist. METHODS: Prospective and randomized study enroling consecutive patients referred for colonoscopy under deep sedation monitored by an anaesthesiologist. In group I, a variable stiffness colonoscope was used, whereas in group II, a standard colonoscope was used. The main variable was the need to change the position of the patient during the endoscopy. RESULTS: Fifty-six patients were included in group I (variable stiffness colonoscope) and 54 in group II (standard colonoscope). The caecum was reached in 92.9% of patients in group I and in 90.7% of group II (P=0.7). The time required to reach the caecum was significantly less in group I (6.14±3.5 vs. 7.7±3.8; P=0.035). The variable stiffness colonoscope was effective in 66.7% of cases. Changing the position of the patient was necessary in 12.5% of cases in group I compared with 33.3% of cases in group II (P=0.01). CONCLUSION: The variable stiffness colonoscope avoids the need to change the patient's position and reduces caecal intubation time in patients undergoing colonoscopy under deep sedation controlled by an anaesthesiologist.

Gastrointestinal Hemorrhage Secondary to Duodenal Cystic Dystrophy in Heterotopic Pancreas.

Cystic dystrophy of the duodenal wall (CDDW) is a complication of heterotopic pancreatic tissue located in the wall of the gastrointestinal tract, characterized by the presence of multiple small cysts, usually found in the wall of the second part of the duodenum. Gastrointestinal hemorrhage due to CDDW is a rare complication. We report the case of a 50-year-old man who was admitted to our hospital for persistent vomiting. The imaging tests confirmed the diagnosis of CDDW. During his stay in hospital, the patient had a gastrointestinal hemorrhage secondary to this disorder, which made it necessary to perform a Roux-en-Y gastrojejunostomy (Billroth III).

Factors associated with non-attendance at outpatient endoscopy.

OBJECTIVE: Non-attendance at endoscopy procedures leads to wasted resources and increased costs. The purpose of this study was to investigate the factors associated with non-attendance. MATERIAL AND METHODS: All patients who attended the outpatient clinic for gastroscopy or colonoscopy examinations were included in the study. Patients who missed their appointment were identified and their data were collected prospectively. Patients who kept their appointment in the same period of time served as controls. RESULTS: Between August 2002 and February 2003, 1051 gastroscopies and 756 colonoscopies were scheduled. A total of 265 patients (14.7%) missed their appointment. No significant differences were found between attendees and non-attendees for mean age, gender, type of examination and day of the week on which the examination was scheduled. The time on the waiting list was longer in patients who did not keep their appointment than in those who did. Fewer appointments were missed in patients with a preferent referral, and among patients referred by their general practitioner a higher percentage failed to keep their appointment compared with those referred by a specialist. In the multivariate analysis, length of time on the waiting list and the source of referral were the only two independent predictive factors for non-attendance. CONCLUSIONS: A longer time on the waiting list and referral by a general practitioner are factors associated with patients failing to keep their endoscopy appointment.