BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial.

OBJECTIVES: Adenoma detection rate (ADR) is an important quality marker at lower GI endoscopy. Higher ADRs are associated with lower postcolonoscopy colorectal cancer rates. The English flexible sigmoidoscopy (FS) screening programme (BowelScope), offers a one-off FS to individuals aged 55 years. However, variation in ADR exists. Large studies have demonstrated improved ADR using Endocuff Vision (EV) within colonoscopy screening, but there are no studies within FS. We sought to test the effect of EV on ADR in a national FS screening population. DESIGN: BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities was a multicentre, randomised controlled trial involving 16 English BowelScope screening centres. Individuals were randomised to Endocuff Vision-assisted BowelScope (EAB) or Standard BowelScope (SB). ADR, polyp detection rate (PDR), mean adenomas per procedure (MAP), polyp characteristics and location, participant experience, procedural time and adverse events were measured. Comparison of ADR within the trial with national BowelScope ADR was also undertaken. RESULTS: 3222 participants were randomised (53% male) to receive EAB (n=1610) or SB (n=1612). Baseline demographics were comparable between arms. ADR in the EAB arm was 13.3% and that in the SB arm was 12.2% (p=0.353). No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics. ADR in the SB control arm was 3.1% higher than the national ADR. CONCLUSION: EV did not improve BowelScope ADR when compared with SB. ADR in both arms was higher than the national ADR. Where detection rates are already high, EV is unable to improve detection further. TRIAL REGISTRATION NUMBERS: NCT03072472, ISRCTN30005319 and CPMS ID 33224.

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 incidence and mortality with screening flexible sigmoidoscopy.

BACKGROUND: The benefits of endoscopic testing for colorectal-cancer screening are uncertain. We evaluated the effect of screening with flexible sigmoidoscopy on colorectal-cancer incidence and mortality. METHODS: From 1993 through 2001, we randomly assigned 154,900 men and women 55 to 74 years of age either to screening with flexible sigmoidoscopy, with a repeat screening at 3 or 5 years, or to usual care. Cases of colorectal cancer and deaths from the disease were ascertained. RESULTS: Of the 77,445 participants randomly assigned to screening (intervention group), 83.5% underwent baseline flexible sigmoidoscopy and 54.0% were screened at 3 or 5 years. The incidence of colorectal cancer after a median follow-up of 11.9 years was 11.9 cases per 10,000 person-years in the intervention group (1012 cases), as compared with 15.2 cases per 10,000 person-years in the usual-care group (1287 cases), which represents a 21% reduction (relative risk, 0.79; 95% confidence interval [CI], 0.72 to 0.85; P<0.001). Significant reductions were observed in the incidence of both distal colorectal cancer (479 cases in the intervention group vs. 669 cases in the usual-care group; relative risk, 0.71; 95% CI, 0.64 to 0.80; P<0.001) and proximal colorectal cancer (512 cases vs. 595 cases; relative risk, 0.86; 95% CI, 0.76 to 0.97; P=0.01). There were 2.9 deaths from colorectal cancer per 10,000 person-years in the intervention group (252 deaths), as compared with 3.9 per 10,000 person-years in the usual-care group (341 deaths), which represents a 26% reduction (relative risk, 0.74; 95% CI, 0.63 to 0.87; P<0.001). Mortality from distal colorectal cancer was reduced by 50% (87 deaths in the intervention group vs. 175 in the usual-care group; relative risk, 0.50; 95% CI, 0.38 to 0.64; P<0.001); mortality from proximal colorectal cancer was unaffected (143 and 147 deaths, respectively; relative risk, 0.97; 95% CI, 0.77 to 1.22; P=0.81). CONCLUSIONS: Screening with flexible sigmoidoscopy was associated with a significant decrease in colorectal-cancer incidence (in both the distal and proximal colon) and mortality (distal colon only). (Funded by the National Cancer Institute; PLCO ClinicalTrials.gov number, NCT00002540.).

Straight to flexible sigmoidoscopy: rationalization of 2-week wait referrals in suspected colorectal cancer.

AIM: The 2-week wait pathway was designed to decrease the time from presentation to primary care of patients with 'red flag' symptoms of suspected cancer for review by a specialist for the diagnosis or exclusion of cancer. In our tertiary referral centre we have found that 968 colonoscopies per year are required to satisfy the demand for the 2-week wait, leading to limited colonoscopy availability for other services. We sought to determine the yield of colorectal cancer found at colonoscopy referred via the 2-week wait and referenced to the original red flag symptoms. This was in order to select the most efficacious alternative primary investigation based upon presenting symptoms. METHOD: Electronic records were retrospectively analysed. All patients who went through the 2-week wait for suspicion of colorectal cancer in 2013 and were found to have colorectal cancer on colonoscopy were included. Patients not undergoing colonoscopy as the first investigation were excluded. The splenic flexure was deemed to be within the range of a flexible sigmoidoscope. RESULTS: In all, 2950 referrals were made. 968 colonoscopies were performed as the primary investigation of which 35 were found to have colorectal cancer. No patients referred with rectal bleeding and another symptom had a tumour more proximal to the range of flexible sigmoidoscopy. 80% of tumours proximal to the splenic flexure were suitable for CT diagnosis alone. CONCLUSION: Our data support the use of flexible sigmoidoscopy alone as an initial investigation for patients presenting with rectal bleeding with or without additional colorectal symptoms. Patients with anaemia (without bleeding) or change in bowel habit (without bleeding) may be investigated with CT colonography alone; colonoscopy may then be used selectively prior to surgery.

Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial.

IMPORTANCE: Colorectal cancer is a major health burden. Screening is recommended in many countries. OBJECTIVE: To estimate the effectiveness of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality in a population-based trial. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of 100,210 individuals aged 50 to 64 years, identified from the population of Oslo city and Telemark County, Norway. Screening was performed in 1999-2000 (55-64-year age group) and in 2001 (50-54-year age group), with follow-up ending December 31, 2011. Of those selected, 1415 were excluded due to prior colorectal cancer, emigration, or death, and 3 could not be traced in the population registry. INTERVENTIONS: Participants randomized to the screening group were invited to undergo screening. Within the screening group, participants were randomized 1:1 to receive once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood testing (FOBT). Participants with positive screening test results (cancer, adenoma, polyp ≥10 mm, or positive FOBT) were offered colonoscopy. The control group received no intervention. MAIN OUTCOMES AND MEASURES: Colorectal cancer incidence and mortality. RESULTS: A total of 98,792 participants were included in the intention-to-screen analyses, of whom 78,220 comprised the control group and 20,572 comprised the screening group (10,283 randomized to receive a flexible sigmoidoscopy and 10,289 to receive flexible sigmoidoscopy and FOBT). Adherence with screening was 63%. After a median of 10.9 years, 71 participants died of colorectal cancer in the screening group vs 330 in the control group (31.4 vs 43.1 deaths per 100,000 person-years; absolute rate difference, 11.7 [95% CI, 3.0-20.4]; hazard ratio [HR], 0.73 [95% CI, 0.56-0.94]). Colorectal cancer was diagnosed in 253 participants in the screening group vs 1086 in the control group (112.6 vs 141.0 cases per 100,000 person-years; absolute rate difference, 28.4 [95% CI, 12.1-44.7]; HR, 0.80 [95% CI, 0.70-0.92]). Colorectal cancer incidence was reduced in both the 50- to 54-year age group (HR, 0.68; 95% CI, 0.49-0.94) and the 55- to 64-year age group (HR, 0.83; 95% CI, 0.71-0.96). There was no difference between the flexible sigmoidoscopy only vs the flexible sigmoidoscopy and FOBT screening groups. CONCLUSIONS AND RELEVANCE: In Norway, once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening. Screening was effective both in the 50- to 54-year and the 55- to 64-year age groups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00119912.

A novel adaptor converts a laparoscope into a high-definition rigid sigmoidoscope.

The rigid sigmoidoscope is an important tool in a surgeon's armamentarium, yet it has remained essentially unchanged despite poor imaging and the inability to project or record the images. Herein we report our initial experience with a novel introducer built from readily available operating room supplies and designed to convert any standard laparoscope into a high-definition rigid sigmoidoscope.

[The role of endoscopic ultrasonography in the diagnosis of rectal cancers]. / Az endoszkópos ultrahangvizsgálat szerepe a rectumtumorok diagnosztikájában.

INTRODUCTION: The exact extent of rectal cancer and regional lymph node involvement are essential for providing the optimal treatment. AIM: The aim of the authors was to evaluate the diagnostic accuracy of endoscopic ultrasonography in routine clinical staging of rectal cancer. METHOD: Outcomes of endoscopic ultrasonography performed between 2006 and 2012 for rectal cancer staging were retrospectively analyzed. The correlation between the endoscopic and pathological stages was evaluated. RESULTS: In patients without neoadjuvant chemotherapy the sensitivity (75% and 73%) and specificity (74% and 80%) of endoscopic ultrasonography for differentiating T1 and T2 stages (respectively) were high, however, it was significantly decreased in differentiation of T3 stage (58%). A weak association was found in different N stages (45-62%). The diagnostic accuracy of endoscopic ultrasound was reduced significantly after the oncological treatment due to the overevaluation (27%) of the findings. After a relatively short learning curve (30 examinations) high correlation was detected between pT and uT stages. CONCLUSIONS: Endoscopic ultrasonography provides great help in staging early rectal cancers. Due to the lower sensitivity in patients receiving neoadjuvant therapy, it is not a useful tool after down-staging.

Systematic review and meta-analysis of the evidence for flexible sigmoidoscopy as a screening method for the prevention of colorectal cancer.

BACKGROUND: Colorectal cancer is a significant cause of death. Removal of precancerous adenomas, and early detection and treatment of cancer, has been shown to reduce the risk of death. The aim of this review and meta-analysis was to determine whether flexible sigmoidoscopy (FS) is an effective population screening method for reducing mortality from colorectal cancer. METHODS: MEDLINE (1946 to December 2012) and Embase (1980-2012, week 15) were searched for randomized clinical trials in which FS was used to screen non-symptomatic adults from a general population, and FS was compared with either no screening or any other alternative screening methods. Meta-analysis was carried out using a random-effects Mantel-Haenzsel model. RESULTS: Twenty-four papers met the inclusion criteria, reporting results from 14 trials. Uptake of FS was usually lower than that for stool-based tests, although FS was more effective at detecting advanced adenoma and carcinoma. FS reduced the incidence of colorectal cancer after screening, and long-term mortality from colorectal cancer, compared with no screening in a selected population. Compared with stool-based tests in a general population, FS was associated with fewer interval cancers. CONCLUSION: FS is efficacious at reducing colorectal cancer mortality compared with no screening. It is more effective at detecting advanced adenoma and carcinoma than stool-based tests. FS may be compromised by poorer uptake. Introduction of FS as a screening method should be done on a pilot basis in populations in which it is not currently used, and close attention should be paid to maximizing uptake. The relative risk of adverse events with FS compared with stool-based tests should be quantified, and its real-world effectiveness evaluated against the most effective stool-based tests.

A new accessory, endoscopic cuff, improves colonoscopic access for complex polyp resection and scar assessment in the sigmoid colon (with video).

BACKGROUND: Difficult and unstable endoscopic access to large sessile/flat colon polyps in the sigmoid colon may prevent successful and complete EMR. OBJECTIVE: We report our experience with the use of an endoscopic cuff, a new endoscopic accessory, to improve endoscopic access during endoscopic therapy and scar assessment. DESIGN: Single-center, retrospective, feasibility case series. SETTING: Tertiary referral academic endoscopy unit. PATIENTS: Nonconsecutive patients referred for endoscopic resection of large flat/sessile sigmoid colon polyps or surveillance of postpolypectomy scars in the sigmoid colon. INTERVENTIONS: When conventional methods to achieve stable access and visualization were unsuccessful, the endoscopic cuff was used to retract sigmoid colon folds. MAIN OUTCOME MEASUREMENTS: Safety, procedural success, and complications. RESULTS: Five patients (mean age 62 years, 3 male/2 female) underwent endoscopic cuff-assisted EMR polypectomy, and 7 patients (mean age 62 years, 2 male/5 female) underwent post-EMR scar surveillance with an endoscopic cuff-assisted flexible sigmoidoscopy. All sessile/flat polyps (mean size 29 mm) or post-EMR scar sites (mean size 15 mm) were located at acute bends in the sigmoid colon. With the endoscopic cuff placed around the tip of the colonoscope, endoscopic access improved significantly by flattening/depressing colon folds close to the lesion/scar. The entire polyp/scar surface was revealed, facilitating a complete polyp excision and a meticulous scar assessment. No immediate or delayed adverse events were seen. LIMITATIONS: Single-center, nonrandomized case series. CONCLUSIONS: An endoscopic cuff appears to be a safe and easily used accessory to facilitate colonoscopic access for complex polypectomy and scar assessment in the sigmoid colon.

European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Quality assurance in endoscopy in colorectal cancer screening and diagnosis.

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on quality assurance in endoscopy includes 50 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of endoscopy and other elements in the screening process, including multidisciplinary diagnosis and management of the disease.

Flexible sigmoidoscopy does not significantly increase polyp and cancer detection yield when used to supplement CT colonography.

BACKGROUND AND AIMS: Flexible sigmoidoscopy (FS) increases polyp and carcinoma detection in addition to double contrast barium enema (DCBE). However, CT colonography (CTC) is now the preferred technique. Our aim was to explore whether FS increases polyp and carcinoma detection rates when used in addition to CTC. METHODS: Patients who underwent FS and CTC between 2007 and 2009 were included and data were collected from patient records. Yields of polyp, adenoma and carcinoma detection were calculated for FS and CTC. RESULTS: In a cohort of 294 patients, CTC detected 36 patients with carcinomas while FS detected 28. One rectal cancer not seen on CTC was diagnosed by FS. Polyps were seen by CTC in 66 and FS in 45 patients. In 5 patients FS found polyps that were not detected by CTC; 3 of which were small adenomas. FS detected extra adenomas or carcinomas in 1.36% (4/294). Adding FS to CTC neither increased the cancer nor the polyp detection yield significantly. CONCLUSIONS: This first study investigating the use of FS in addition to CTC detected little additional pathology. The routine use of FS as a supplement to CTC for adenoma and carcinoma detection is of questionable utility.

Early, minimally invasive closure of anastomotic leaks: a new concept.

Chronic pelvic sepsis after ileoanal or coloanal anastomosis precludes ileostomy closure and, even if closure is ultimately possible, function of the neorectum is badly affected. Early closure of the anastomotic leak might prevent chronic pelvic sepsis and its adverse sequelae. In our experience of early closure in a consecutive group of six patients with a leaking low anastomosis (five with ileoanal pouch anastomosis and one after a low anterior resection), we were able to achieve anastomotic closure in five by means of initial endosponge therapy followed either by early suture (four patients) or endoscopic clip repair (one patient). Early minimally invasive closure of low anastomotic leaks is therefore possible provided that the para-anastomotic cavity is drained well prior to closure and the anastomosis is defunctioned.

Randomized controlled trial: Flexible sigmoidoscopy as an adjunct to faecal occult blood testing in population screening.

OBJECTIVES: Flexible sigmoidoscopy screening at around age 60 can reduce colorectal cancer incidence. Insufficient evidence exists on flexible sigmoidoscopy at age 60 in a population being offered biennial faecal occult blood test screening from age 50. This randomized controlled trial assessed if flexible sigmoidoscopy would be an effective adjunct to faecal occult blood test. METHODS: In the Scottish Bowel Screening Programme between June 2014 and December 2015, 51,769 individuals were randomized to be offered flexible sigmoidoscopy instead of faecal occult blood test at age 60 or to continue faecal occult blood test. Those not accepting flexible sigmoidoscopy and those with normal flexible sigmoidoscopy were offered faecal occult blood test. All with flexible sigmoidoscopy-detected neoplasia or a positive faecal occult blood test result were offered colonoscopy. RESULTS: Overall flexible sigmoidoscopy uptake was 17.8%, higher in men than women, and decreased with increasing deprivation (25.7% in the least to 9.2% in the most deprived quintile). In those who underwent flexible sigmoidoscopy, detection rate for colorectal cancer was 0.13%, for adenoma 7.27%, and for total neoplasia 7.40%. In those who underwent colonoscopy after a positive flexible sigmoidoscopy, detection rate for colorectal cancer was 0.28%, adenoma 8.66%, and total neoplasia 8.83%. On an intention to screen basis, there was no difference in colorectal cancer detection rate between the study and control groups. Adenoma and total neoplasia detection rate were significantly higher in the study group, with odds ratios of 5.95 (95%CI: 4.69-7.56) and 5.10 (95%CI: 4.09-6.35), respectively. CONCLUSIONS: In a single screening round at age 60, there was low uptake and neoplasia detection rate. Flexible sigmoidoscopy detected significantly more neoplasia than faecal occult blood test alone.

Training and assessment in flexible sigmoidoscopy: using a novel direct observation of procedural skills (DOPS) assessment tool.

BACKGROUND AND AIMS: Data supporting milestone development during flexible sigmoidoscopy (FS) training are lacking. We aimed to present validity evidence for our formative direct observation of procedural skills (DOPS) assessment in FS, and use DOPS to establish competency benchmarks and define learning curves for a national training cohort. METHODS: This prospective UK-wide (211 centres) study included all FS formative DOPS assessments submitted to the national e-portfolio. Reliability was estimated from generalisability theory analysis. Item and global DOPS scores were correlated with lifetime procedure count to study learning curves, with competency benchmarks defined using contrasting groups analysis. Multivariable binary logistic regression was performed to identify independent predictors of DOPS competence. RESULTS: This analysis included 3,616 DOPS submitted for 468 trainees. From generalisability analysis, sources of overall competency score variance included: trainee ability (27%), assessor stringency (15%), assessor subjectivity attributable to the trainee (18%) and case-to-case variation (40%), which enabled the modelling of reliability estimates. The competency benchmark (mean DOPS score: 3.84) was achieved after 150-174 procedures. Across the cohort, competency development occurred in the order of: pre-procedural (50-74), non-technical (75-149), technical (125-174) and post-procedural (175-199) skills. Lifetime procedural count (p<0.001), case difficulty (p<0.001), and lifetime formative DOPS count (p=0.001) were independently associated with DOPS competence, but not trainee or assessor specialty. CONCLUSION: Sigmoidoscopy DOPS can provide valid and reliable assessments of competency during training and can be used to chart competency development. Contrary to earlier studies, based on destination-orientated endpoints, overall competency in sigmoidoscopy was attained after 150 lifetime procedures.