Randomized controlled trial of effects of a familiarization video and patient-controlled Entonox inhalation on patient stress levels and clinical efficacy of flexible sigmoidoscopy without analgesia or sedation for investigation of fresh rectal bleeding.

BACKGROUND AND AIM: Flexible sigmoidoscopy (FS) without analgesia or sedation can be unpleasant for patients, resulting in unsatisfactory examinations. Prior familiarization videos (FVs) and intra-procedural Entonox inhalation have shown inconsistent effects. This study investigated their effects on undesirable participant factors (anxiety, stress, discomfort, pain, satisfaction, later unpleasant recall of procedure, and vasovagal reactions) and clinical effectiveness (extent of bowel seen, lesions detected, and procedural/recovery times). METHODS: This cluster-randomized single-center study evaluated 138 participants undergoing FS. There were 46 controls, 49 given access to FV, and 43 access to both FV and self-administered Entonox. Participant factors were measured by self-administered questionnaires, independent nurse assessments, and heart rate variability (HRV) metrics. RESULTS: Questionnaires showed that the FV group was slightly more tense and upset before FS, but knowledge of Entonox availability reduced anxiety. Nonlinear HRV metrics confirmed reduced intra-procedural stress response in the FV/Entonox group compared with controls and FV alone (P < 0.05). Entonox availability allowed more bowel to be examined (P < 0.001) but increased procedure time (P < 0.05), while FV alone had no effect. FV/Entonox participants reported 1 month after FS less discomfort during the procedure. Other comparisons showed no significant differences between treatment groups, although one HRV metric showed some potential to predict vasovagal reactions. CONCLUSIONS: Entonox availability significantly improved clinical effectiveness and caused a slight reduction in undesirable participant factors. The FV alone did not reduce undesirable participant factors or improve clinical effectiveness. Nonlinear HRV metrics recorded effects in agreement with stress reduction and may be useful for prediction of vasovagal events in future studies.

The risk of bleeding and perforation from sigmoidoscopy or colonoscopy in colorectal cancer screening: A systematic review and meta-analyses.

INTRODUCTION: Physical harm from Colorectal Cancer Screening tends to be inadequately measured and reported in clinical trials. Also, studies of ongoing Colorectal Cancer Screening programs have found more frequent and severe physical harm from screening procedures, e.g., bleeding and perforation, than reported in previous trials. Therefore, the objectives of the study were to systematically review the evidence on the risk of bleeding and perforation in Colorectal Cancer Screening. DESIGN: Systematic review with descriptive statistics and random-effects meta-analyses. METHODS: We systematically searched five databases for studies investigating physical harms related to Colorectal Cancer Screening. We assessed the internal and the external validity using the ROBINS-I tool and the GRADE approach. Harm estimates was calculated using mixed Poisson regression models in random-effect meta-analyses. RESULTS: We included 89 studies. Reporting and measurement of harms was inadequate in most studies. In effect, the risk of bias was critical in 97.3% and serious in 98.3% of studies. All GRADE ratings were very low. Based on severe findings with not-critical risk of bias and 30 days follow-up, the risk of bleedings per 100,000 people screened were 8 [2;24] for sigmoidoscopy, 229 [129;408] for colonoscopy following fecal immunochemical test, 68 [39;118] for once-only colonoscopy, and 698 [443;1045] for colonoscopy following any screening tests. The risk of perforations was 88 [56;138] for colonoscopy following fecal immunochemical test and 53 [25;112] for once-only colonoscopy. There were no findings within the subcategory severe perforation with long-term follow-up for colonoscopy following any screening tests and sigmoidoscopy. DISCUSSION: Harm estimates varied widely across studies, reporting and measurement of harms was mostly inadequate, and the risk of bias and GRADE ratings were very poor, collectively leading to underestimation of harm. In effect, we consider our estimates of perforation and bleeding as conservative, highlighting the need for better reporting and measurement in future studies. TRIAL REGISTRATION: PROSPERO registration number: CRD42017058844.

Detection of Ischemic Colitis on Routine Lower Endoscopy and Its Implications After Repair of Ruptured Abdominal Aortic Aneurysm.

BACKGROUND: Ischemic colitis (IC) is a known significant complication after repair of a ruptured abdominal aortic aneurysm (rAAA). Lower endoscopy (colonoscopy or flexible sigmoidoscopy) is a helpful adjunct to aid decision making for surgical exploration. We believe routine use of lower endoscopy after rAAA repair provides better patient care through expeditious diagnosis and surgical care. METHODS: We performed a retrospective chart review of rAAA repairs from 2008 to 2019. All patients undergo screening lower endoscopy after rAAA repair at our institution. The incidence of IC, mortality, and diagnostic characteristics of routine lower endoscopy was analyzed. RESULTS: Of these, 182 patients underwent rAAA repair, among which 139 (76%) underwent routine lower endoscopy. Ischemic colitis of any grade was diagnosed in 25% of patients. The 30-day mortality was 11% compared to 19% in those without lower endoscopy. The presence of IC portended a 4-fold increase in mortality rate compared to those without (26% vs 6%, P = .005). Surgical exploration rate was 8% after routine lower endoscopy. Grade III ischemia on lower endoscopy had a sensitivity of 50% (95% CI 12-88) and specificity of 99% (95% CI 94-100) for transmural necrosis. DISCUSSION: We found increased incidence of IC and reliable diagnostic characteristics of routine lower endoscopy in predicting the presence of transmural colonic ischemia. There was decreased mortality with use of routine lower endoscopy but this was not statistically significant.

An Observational Analysis of a Novel Digital Rectoscope.

BACKGROUND: This is an analysis of the first 50 in-human uses of a novel digital rigid sigmoidoscope. The technology provides digital image capture, telemedicine capabilities, improved ergonomics, and the ability to biopsy under pneumorectum while maintaining the low cost of conventional rigid sigmoidoscopy. The primary outcome was adverse events, and the secondary outcome was diagnostic view. PRELIMINARY RESULTS: Fifty patients underwent outpatient (n = 25) and surgical rectal assessment (n = 25), with a mean age of 60 years. This included 31 men and 19 women with 12 different clinical use indications. No adverse events were reported, and no defects were reported with the instrumentation. Satisfactory diagnoses were obtained in 48 (96%) of 50 uses, images were captured in 48 (96%) of 50 uses, and biopsies were successfully taken in 13 uses (26%). No adverse events were recorded. Independent reviewers of recorded videos agreed on the quality and diagnostic value of the images with a κ of 0.225 (95% CI, 0.144-0.305) when assessing whether the target pathology was adequately visualized. IMPACT OF INNOVATION: The improved views afforded by digital rectoscopy facilitated a satisfactory clinical diagnosis in 96% of uses. The device was successfully deployed in the operating room and outpatients irrespective of bowel preparation method, where it has the potential to replace flexible sigmoidoscopy for specific use cases. The technology provides a high-quality image and video that can be securely recorded for documentation and medicolegal purposes with agreement between blinded users despite a lack of standardized training and heterogenous pathology. We perceive significant impact of this technology for the assessment of colorectal anastomoses, the office management of colitis, "watch and wait," and for diagnostic support in rectal cancer diagnosis. The technology has significant potential to facilitate proctoring and training, and it now requires prospective trials to validate its diagnostic accuracy against more costly flexible sigmoidoscopy systems.

Timing of recurrences of TEM resected rectal neoplasms is variable as per the surveillance practices of one tertiary care institution.

Transanal endoscopic microsurgery (TEM) is widely used for the excision of rectal adenomas and early rectal adenocarcinoma. Few recommendations currently exist for surveillance of lesions excised by TEM. The purpose of this study was to review the surveillance practices and the patterns of recurrence among TEM resected lesions at a tertiary care hospital. A retrospective chart review was performed on all patients who underwent TEM for rectal adenoma or adenocarcinoma before June 2017. In our study population of 114 patients, the final pathology included 78 (68%) adenomas and 36 (32%) adenocarcinomas. Of the adenocarcinomas 23, 9, and 4 were T1, T2, T3 lesions, respectively. Of those, 25 patients opted for surveillance instead of further treatment. The most commonly recommended endoscopic surveillance strategy by our group for both adenomas and adenocarcinomas excised by TEM was flexible sigmoidoscopy every 6 months for 2 years. Recurrences occurred in 4/78 (5.1%) adenoma patients, all found within 16.9 months of surgery, and in 4/25 (16%) adenocarcinoma patients, found between 7.4 and 38.5 months post-surgery. Our data highlights the fact that the timing of recurrences post TEM surgery is variable. Further studies looking at recurrence patterns are needed in order to create comprehensive guidelines for surveillance of these patients.

Safety of Flexible Sigmoidoscopy in Pregnant Patients with Known or Suspected Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Lower gastrointestinal endoscopy is crucial in the diagnosis and staging of inflammatory bowel disease (IBD). However, there are limited safety data in pregnant populations, resulting in conservative society guidelines and practice patterns favoring diagnostic delay. We studied whether performance of flexible sigmoidoscopy is associated with adverse events in pregnant patients with known or suspected IBD. METHODS: A retrospective cohort study was conducted at the University of California San Francisco (UCSF) between April 2008 and April 2019. Female patients aged between 18 and 48 years who were pregnant at the time of endoscopy were identified. All patient records were reviewed to determine disease, pregnancy outcomes, and lifestyle factors. Two independent reviewers performed the data abstraction. Adverse events were assessed for temporal relation with endoscopy. RESULTS: We report the outcomes of 48 pregnant patients across all trimesters who underwent lower endoscopy for suspected or established IBD. There were no hospitalizations or adverse obstetric events temporally associated with sigmoidoscopy. 78% (38/50) of lower endoscopies performed in the patients resulted in a change in treatment following sigmoidoscopy. 12% (5/43) of the lower endoscopies performed in patients with known IBD showed no endoscopic evidence of disease activity despite symptoms. CONCLUSIONS: Lower endoscopy in the pregnant patient with known or suspected IBD is low risk and affects therapeutic decision making. It should not be delayed in patients with appropriate indications.

Colorectal cancer screening with faecal immunochemical testing, sigmoidoscopy or colonoscopy: a microsimulation modelling study.

OBJECTIVE: To estimate benefits and harms of different colorectal cancer screening strategies, stratified by (baseline) 15-year colorectal cancer risk. DESIGN: Microsimulation modelling study using MIcrosimulation SCreening ANalysis-Colon (MISCAN-Colon). SETTING: A parallel guideline committee (BMJ Rapid Recommendations) defined the time frame and screening interventions, including selection of outcome measures. POPULATION: Norwegian men and women aged 50-79 years with varying 15-year colorectal cancer risk (1-7%). COMPARISONS: Four screening strategies were compared with no screening: biennial or annual faecal immunochemical test (FIT) or single sigmoidoscopy or colonoscopy at 100% adherence. MAIN OUTCOME MEASURES: Colorectal cancer mortality and incidence, burdens, and harms over 15 years of follow-up. The certainty of the evidence was assessed using the GRADE approach. RESULTS: Over 15 years of follow-up, screening individuals aged 50-79 at 3% risk of colorectal cancer with annual FIT or single colonoscopy reduced colorectal cancer mortality by 6 per 1000 individuals. Single sigmoidoscopy and biennial FIT reduced it by 5 per 1000 individuals. Colonoscopy, sigmoidoscopy, and annual FIT reduced colorectal cancer incidence by 10, 8, and 4 per 1000 individuals, respectively. The estimated incidence reduction for biennial FIT was 1 per 1000 individuals. Serious harms were estimated to be between 3 per 1000 (biennial FIT) and 5 per 1000 individuals (colonoscopy); harms increased with older age. The absolute benefits of screening increased with increasing colorectal cancer risk, while harms were less affected by baseline risk. Results were sensitive to the setting defined by the guideline panel. Because of uncertainty associated with modelling assumptions, we applied a GRADE rating of low certainty evidence to all estimates. CONCLUSIONS: Over a 15 year period, all screening strategies may reduce colorectal cancer mortality to a similar extent. Colonoscopy and sigmoidoscopy may also reduce colorectal cancer incidence, while FIT shows a smaller incidence reduction. Harms are rare and of similar magnitude for all screening strategies.

Colorectal cancer screening with faecal testing, sigmoidoscopy or colonoscopy: a systematic review and network meta-analysis.

OBJECTIVE: Evaluate effectiveness, harms and burdens of faecal blood testing, sigmoidoscopy and colonoscopy screening for colorectal cancer over 15 years. DESIGN: We performed an update of a Cochrane systematic review, and performed network meta-analysis comparing randomised trials evaluating colorectal cancer screening with guaiac faecal occult blood test (gFOBT) (annual, biennial), faecal immunochemical test (FIT) (annual, biennial), sigmoidoscopy (once-only) or colonoscopy (once-only) in a healthy population, aged 50-79 years. We conducted subgroup analysis on sex. Follow-up >5 years was required for analysis of colorectal cancer incidence and mortality. RESULTS: 12 randomised trials proved eligible. Compared with no-screening, we found high certainty evidence for sigmoidoscopy screening slightly reducing colorectal cancer incidence (relative risk (RR) 0.76; 95% confidence interval (CI 0.70 to 0.83) and mortality (RR 0.74; 95% CI 0.69 to 0.80), while gFOBT screening had little or no difference on colorectal cancer incidence, but slightly reduced colorectal cancer mortality (annual: RR 0.69; 95% CI 0.56 to 0.86, biennial: RR 0.88; 95% CI 0.82 to 0.93). No screening test reduced mortality nor incidence by more than six per 1000 screened over 15 years. Sigmoidoscopy had a greater effect in men, for both colorectal cancer incidence (women: RR 0.86; 95% CI 0.81 to 0.92, men: RR 0.75, 95% CI 0.71 to 0.79), and mortality (women: RR 0.85; 95% CI 0.71 to 0.96, men: RR 0.67; 95% CI 0.61 to 0.75) (moderate certainty). CONCLUSIONS: In a 15-year perspective, sigmoidoscopy reduces colorectal cancer incidence, while sigmoidoscopy, annual and biennial gFOBT all reduce colorectal cancer mortality. Sigmoidoscopy may reduce colorectal cancer incidence and mortality more in men than in women. PROSPERO REGISTRATION NUMBER: CRD42018093401.

Safe investigation of isolated change in bowel habit with a flexible sigmoidoscopy? A systematic review and meta-analysis.

INTRODUCTION: Public awareness campaigns have led to increasing referrals of patients to colorectal surgery for possible cancer. Change in bowel habit, is traditionally described as a symptom of a left sided bowel cancer. If this is the case in practice, it raises the potentially attractive option of investigating such patients with flexible sigmoidoscopy only. This study sought to systematically review the literature describing tumour location of patients with bowel cancer presenting with left-sided symptoms to establish the safety of potential investigation of these patients with flexible sigmoidoscopy alone. METHODS: A systematic review of studies reporting both the presenting symptoms of patients with bowel cancer and the location of their cancer in the bowel was prospectively registered (CRD42017072492). MEDLINE, EMBASE and CENTRAL were searched with no date or language restriction. RESULTS: Seven studies were included. Isolated change in bowel habit (with or without rectal bleeding) was a presenting symptom of 73% (95% CI 41-96%, I2 = 99%) of left-sided cancers but also in 13% (95% CI 2-30%, I2 = 96%) of right-sided cancers. In all patients with cancer who presented with isolated change in bowel habit (with or without rectal bleeding), the cancer was right sided in 8% (95% CI 4-12%, I2 = 69%). CONCLUSIONS: There is a higher than expected risk that if a cancer is diagnosed in a patient presenting with either an isolated change in bowel habit or a combination of change in bowel habit with rectal bleeding, the cancer may be right sided.

[Perforation as a delayed complication after endoscopic full-thickness resection in a recurrent adenoma of the sigmoid]. / Perforation als Spätkomplikation nach endoskopischer Vollwandresektion eines Rezidivadenoms im Colon sigmoideum.

The endoscopic full-thickness resection (EFTR) is established in ablation of recurrent colorectal adenomas, which cannot be removed by endoscopic resection in cases of fibrosis. The EFTR can be applied with low risk, in one step, with the use of special devices, such as the full-thickness resection device (FTRD®). The main risks described in literature are bleeding and perforations. The mentioned perforations were explained by previous defects of the device system or patient-related predisposed parameters for perforation.We report the case of a 55-year old woman who underwent an endoscopic full-thickness resection with the FTRD® due to a recurrent adenoma with high-grade intraepithelial neoplasm in the sigmoid. After primary uncomplicated development, she presented with a secondary perforation with purulent peritonitis seven days after intervention, so a sigmoid-resection was necessary. There were no signs of defects with the FTRD® system or patient-related predisposed parameters, which prefer a perforation.Our case-report demonstrates the necessity for clinical follow up, after primary uncomplicated endoscopic full-thickness resection, to recognize delayed complications.

Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review.

OBJECTIVES: Addressing procedure-related anxiety should improve adherence to colorectal cancer screening programs and diagnostic colonoscopy. We performed a systematic review to assess anxiety among individuals undergoing colonoscopy or flexible sigmoidoscopy (FS). METHODS: We searched multiple electronic databases for studies evaluating anxiety associated with colonoscopy or FS published from 2005 to 2017. Two reviewers independently identified studies, extracted data, and assessed study quality. The main outcomes were the magnitude of pre-procedure anxiety, types of concerns, predictors of anxiety, and effectiveness of anxiety-lowering interventions in individuals undergoing lower endoscopy. The protocol was prospectively registered in PROSPERO. RESULTS: Fifty-eight studies (24,490 patients) met the inclusion criteria. Patients undergoing colonoscopy had a higher mean level of anxiety than that previously reported in the general population, with some studies reporting more than 50% of patients having moderate-to-severe anxiety. Areas of anxiety-related concern included bowel preparation, difficulties with the procedure (embarrassment, pain, possible complications, and sedation), and concerns about diagnosis; including fear of being diagnosed with cancer. Female gender, higher baseline anxiety, functional abdominal pain, lower education, and lower income were associated with greater anxiety prior to colonoscopy. Providing higher-quality information before colonoscopy, particularly with a video, shows promise as a way of reducing pre-procedure anxiety but the studies to date are of low quality. CONCLUSIONS: A large proportion of patients undergoing colonoscopy report anxiety before the procedure. Improvement in pre-procedure information delivery and evaluation of approaches to reduce anxiety is required, especially for those with predictors of pre-procedure anxiety.

Accuracy of Routine Endoscopy Diagnosing Colonic Ischaemia After Abdominal Aortic Aneurysm Repair: A Meta-analysis.

BACKGROUND: Colonic ischaemia (CI) is a devastating complication after abdominal aortic aneurysm (AAA) surgery. The aim of this review was to evaluate the diagnostic test accuracy of routine endoscopy in diagnosing CI after treatment for elective and acute AAA. PATIENTS AND METHODS: The Pubmed and Embase database searches resulted in 1188 articles. Prospective studies describing routine post-operative colonoscopy or sigmoidoscopy after elective or emergency AAA repair were included. The study quality was assessed with the QUADAS-2 tool. Sensitivity and specificity forest plots were drawn. Diagnostic odds ratios were calculated by a random effect model. RESULTS: Twelve articles were included consisting of 718 AAA patients of whom 44% were treated electively, 56% ruptured and, 6% by endovascular repair. Of all patients, 20.8% were identified with CI (all grades), and 6.5% of patients had Grade 3 CI. The pooled diagnostic odds ratio for all grades of CI on endoscopy was 26.60 (95% CI 8.86-79.88). The sensitivity and specificity of endoscopy for detection of Grade 3 CI after AAA repair was 0.52 (95% CI, 0.31-0.73) and 0.97 (95% CI 0.95-0.99) respectively. The positive post-test probability is up to 60% in all kinds of AAA patients and 68% in ruptured AAA patients. CONCLUSION: Routine endoscopy is highly accurate for ruling out CI after AAA repair. Clinicians should be aware that endoscopy is less accurate in diagnosing the presence of the clinically relevant transmural CI. Endoscopy is a safe diagnostic test to use routinely as none of the studies reported adverse events.

Evaluation of the benefits, harms and cost-effectiveness of potential alternatives to iFOBT testing for colorectal cancer screening in Australia.

The Australian National Bowel Cancer Screening Program (NBCSP) will fully roll-out 2-yearly screening using the immunochemical Faecal Occult Blood Testing (iFOBT) in people aged 50 to 74 years by 2020. In this study, we aimed to estimate the comparative health benefits, harms, and cost-effectiveness of screening with iFOBT, versus other potential alternative or adjunctive technologies. A comprehensive validated microsimulation model, Policy1-Bowel, was used to simulate a total of 13 screening approaches involving use of iFOBT, colonoscopy, sigmoidoscopy, computed tomographic colonography (CTC), faecal DNA (fDNA) and plasma DNA (pDNA), in people aged 50 to 74 years. All strategies were evaluated in three scenarios: (i) perfect adherence, (ii) high (but imperfect) adherence, and (iii) low adherence. When assuming perfect adherence, the most effective strategies involved using iFOBT (annually, or biennially with/without adjunct sigmoidoscopy either at 50, or at 54, 64 and 74 years for individuals with negative iFOBT), or colonoscopy (10-yearly, or once-off at 50 years combined with biennial iFOBT). Colorectal cancer incidence (mortality) reductions for these strategies were 51-67(74-80)% in comparison with no screening; 2-yearly iFOBT screening (i.e. the NBCSP) would be associated with reductions of 51(74)%. Only 2-yearly iFOBT screening was found to be cost-effective in all scenarios in context of an indicative willingness-to-pay threshold of A$50,000/life-year saved (LYS); this strategy was associated with an incremental cost-effectiveness ratio of A$2,984/LYS-A$5,981/LYS (depending on adherence). The fully rolled-out NBCSP is highly cost-effective, and is also one of the most effective approaches for bowel cancer screening in Australia.

Flexible Sigmoidoscopy and CT Colonography Screening: Patients' Experience with and Factors for Undergoing Screening-Insight from the Proteus Colon Trial.

Purpose To compare the acceptability of computed tomographic (CT) colonography and flexible sigmoidoscopy (FS) screening and the factors predicting CT colonographic screening participation, targeting participants in a randomized screening trial. Materials and Methods Eligible individuals aged 58 years (n = 1984) living in Turin, Italy, were randomly assigned to be invited to screening for colorectal cancer with FS or CT colonography. After individuals who had died or moved away (n = 28) were excluded, 264 of 976 (27.0%) underwent screening with FS and 298 of 980 (30.4%) underwent CT colonography. All attendees and a sample of CT colonography nonattendees (n = 299) were contacted for a telephone interview 3-6 months after invitation for screening, and screening experience and factors affecting participation were investigated. Odds ratios (ORs) were computed by means of multivariable logistic regression. Results For the telephone interviews, 239 of 264 (90.6%) FS attendees, 237 of 298 (79.5%) CT colonography attendees, and 182 of 299 (60.9%) CT colonography nonattendees responded. The percentage of attendees who would recommend the test to friends or relatives was 99.1% among FS and 93.3% among CT colonography attendees. Discomfort associated with bowel preparation was higher among CT colonography than FS attendees (OR, 2.77; 95% confidence interval [CI]: 1.47, 5.24). CT colonography nonattendees were less likely to be men (OR, 0.36; 95% CI: 0.18, 0.71), retired (OR, 0.31; 95% CI: 0.13, 0.75), to report regular physical activity (OR, 0.37; 95% CI: 0.20, 0.70), or to have read the information leaflet (OR, 0.18; 95% CI: 0.08, 0.41). They were more likely to mention screening-related anxiety (mild: OR, 6.30; 95% CI: 2.48, 15.97; moderate or severe: OR, 3.63; 95% CI: 1.87, 7.04), erroneous beliefs about screening (OR, 32.15; 95% CI: 6.26, 165.19), or having undergone a recent fecal occult blood test (OR, 13.69; 95% CI: 3.66, 51.29). Conclusion CT colonography and FS screening are well accepted, but further reducing the discomfort from bowel preparation may increase CT colonography screening acceptability. Negative attitudes, erroneous beliefs about screening, and organizational barriers are limiting screening uptake; all these factors are modifiable and therefore potentially susceptible to interventions. © RSNA, 2017 Online supplemental material is available for this article.

Acceptability of two colorectal cancer screening tests: pain as a key determinant in sigmoidoscopy.

Background Participants' experience with a screening test can influence adherence, and therefore the efficacy of screening programs. We compared screening with unsedated flexible sigmoidoscopy and fecal immunochemical testing (FIT) for participants' satisfaction with the decision and for willingness to repeat colorectal cancer screening. Methods In a prospective, randomized trial 3257 individuals (50 - 74 years) were invited to either flexible sigmoidoscopy or FIT (1:1), of whom 1650 took up the offer (52.6 %). In total, 1497 screening participants completed at least one questionnaire, either before screening, and/or at three time points in the following year, that measured willingness to repeat screening, willingness to recommend screening, and satisfaction with decision to attend. There were 769 and 728 responders in the flexible sigmoidoscopy and FIT group, respectively. Additionally, 581 flexible sigmoidoscopy participants also completed a pain questionnaire. Results 1 year later, 10 % of the flexible sigmoidoscopy participants were not willing to repeat screening, compared to 5 % of FIT participants. A higher percentage of women compared to men would not repeat flexible sigmoidoscopy screening (adjusted odds ratio [OR] 2.52, 95 % confidence interval [95 %CI] 1.48 to 4.28). Notably, 22 % of women reported pain during flexible sigmoidoscopy compared to 5 % of men. When we added pain to the statistical model, pain was significantly associated with unwillingness to repeat flexible sigmoidoscopy (OR 3.15, 95 %CI 1.68 to 5.87), while gender was no longer associated (OR 1.53, 95 %CI 0.82 to 2.88). Conclusion Acceptability for flexible sigmoidoscopy and for FIT was high among Norwegian screening participants, though FIT participants were more willing to repeat screening. Women were less willing to repeat screening with flexible sigmoidoscopy compared to men. This gender difference seemed partly due to pain, and therefore preventable.This study is registered at ClinicalTrials.gov: NCT01538550.

The use of a transparent cap in sigmoidoscopy-A randomized controlled clinical trial on pain, time and success rate.

Trials on cap-assisted colonoscopy have shown a reduction in pain, faster intubation time and a higher success rate attributed to the use of the cap. No similar studies have been published on sigmoidoscopy even though it is a common procedure associated with significant pain. Our objective was to investigate whether the use of a transparent cap for sigmoidoscopy has an impact on pain, time or success rate. To mimic the tendencies of daily clinical practice, the trainee endoscopist performed the procedures, and no analgesics or sedatives were used. We conducted a randomized, controlled clinical trial with a parallel design consisting of two groups masked for the intervention. The primary endpoint was pain, recorded on a 100-mm visual analogue scale (VAS). Our results found cap-assisted sigmoidoscopy to be significantly more painful than non-cap-assisted sigmoidoscopy (median VAS 50 vs. 38 mm; p = 0.047). We found no differences on time or success rate due to the cap. Our results suggest pain management, e.g. analgesics which is not routinely used for sigmoidoscopy, when a cap is used to gain therapeutic or diagnostic advantages. ClinicalTrials.gov Identifier: NCT02243930.

Risk of infection following colonoscopy and sigmoidoscopy in symptomatic patients.

Background and study aims Previous studies describing the incidence of infection after colonoscopy and sigmoidoscopy are limited. The aim of this study was to determine the incidence of infection, and to propose a nomogram to predict the probability of infection following colonoscopy and sigmoidoscopy in symptomatic patients. Patients and methods A nationwide retrospective study was conducted by analyzing the National Health Insurance Research Database of Taiwan. The incidence of infection within 30 days after colonoscopy and sigmoidoscopy was assessed and compared with a control group matched at a ratio of 1:1 based on age, sex, and the date of examination. Results In all, 112 543 patients who underwent colonoscopy or sigmoidoscopy and 112 543 matched patients who did not undergo these procedures were included. The overall incidence of infection within 30 days after colonoscopy and sigmoidoscopy was 0.37 %, which was significantly higher than that of the control group (0.04 %; P < 0.001). Diverticulitis, peritonitis, and appendicitis were the most common infections. Patients who underwent colonoscopy or sigmoidoscopy had a 9.38-fold risk of infection (95 % confidence interval, 6.81 - 12.93; P < 0.001) compared with the control group. The predicted infection-free rates of the nomogram were closely aligned with the actual infection-free rates, with a bootstrapping concordance index of 0.763. Conclusions Colonoscopy and sigmoidoscopy are associated with an increased risk of infection, which may occur after these procedures. Our nomogram may provide clinicians with an easy tool to evaluate the risk of infection after colonoscopy and sigmoidoscopy in symptomatic patients.