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.

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.

Orina verde después de una rectosigmoidoscopia / Green urine after a rectosigmoidoscopy

No disponible

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.

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.

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.

Reduced incidence and mortality from colorectal cancer with flexible-sigmoidoscopy screening: a meta-analysis.

AIM: To conduct a systematic review and meta-analysis of published population-based randomized controlled trials (RCTs). METHODS: RCTs evaluating the difference in mortality and incidence of colorectal cancer (CRC) between a screening flexible sigmoidoscopy (FS) group and control group (not assigned to screening FS) with a minimum 5 years median follow-up were identified by a search of MEDLINE and EMBASE databases and the Cochrane Central Register for Controlled Trials through August 2013. Random effects model was used for meta-analysis. RESULTS: Four RCTs with a total of 165659 patients in the FS group and 249707 patients in the control group were included in meta-analysis. Intention-to-treat analysis showed that there was a 22% risk reduction in total incidence of CRC (RR = 0.78, 95%CI: 0.74-0.83), 31% in distal CRC incidence (RR = 0.69, 95%CI: 0.63-0.75), and 9% in proximal CRC incidence (RR = 0.91, 95%CI: 0.83-0.99). Those who underwent screening FS were 18% less likely to be diagnosed with advanced CRC (OR = 0.82, 95%CI: 0.71-0.94). There was a 28% risk reduction in overall CRC mortality (RR = 0.72, 95%CI: 0.65-0.80) and 43% in distal CRC mortality (RR = 0.57, 95%CI: 0.45-0.72). CONCLUSION: This meta-analysis suggests that screening FS can reduce the incidence of proximal and distal CRC and mortality from distal CRC along with reduction in diagnosis of advanced CRC.

[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.

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.

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.