Colonoscopy-related Adverse Events Research Articles

Continuing Medical Education Questions: March 2022.

Article Title: Colonoscopy related adverse events in patients with abnormal stool-based tests-A systematic review of literature and meta-analysis of outcomes.

Colonoscopy-Related Adverse Events in Patients With Abnormal Stool-Based Tests: A Systematic Review of Literature and Meta-analysis of Outcomes.

Colorectal cancer (CRC) screening programs based on the fecal immunochemical test (FIT) and guaiac-based fecal occult blood (gFOBT) are associated with a substantial reduction in CRC incidence and mortality. We conducted a systematic review and comprehensive meta-analysis to evaluate colonoscopy-related adverse events in individuals with a positive FIT or gFOBT. A systematic and detailed search was run in January 2021, with the assistance of a medical librarian for studies reporting on colonoscopy-related adverse events as part of organized CRC screening programs. Meta-analysis was performed using the random-effects model, and the results were expressed for pooled proportions along with relevant 95% confidence intervals (CIs). A total of 771,730 colonoscopies were performed in patients undergoing CRC screening using either gFOBT or FIT across 31 studies. The overall pooled incidence of severe adverse events in the entire patient cohort was 0.42% (CI 0.20-0.64); I2 = 38.76%. In patients with abnormal gFOBT, the incidence was 0.2% (CI 0.1-0.3); I2 = 24.6%, and in patients with a positive FIT, it was 0.4% (CI 0.2-0.7); I2 = 48.89%. The overall pooled incidence of perforation, bleeding, and death was 0.13% (CI 0.09-0.21); I2 = 22.84%, 0.3% (CI 0.2-0.4); I2 = 35.58%, and 0.01% (CI 0.00-0.01); I2 = 33.21%, respectively. Our analysis shows that in colonoscopies performed after abnormal stool-based testing, the overall risk of severe adverse events, perforation, bleeding, and death is minimal.

Endoscopic management of delayed bleeding after polypectomy of small colorectal polyps: two or more clips may be safe.

BackgroundThe resection of small colorectal polyps (≤10 mm) is routine for endoscopists. However, the management of one of its main complications, namely delayed (within 14 days) postpolypectomy bleeding (DPPB), has not been clearly demonstrated. We aimed to assess the role of coloscopy in the management of DPPB from small colorectal polyps and identify the associated factors for initial hemostatic success.MethodsWe conducted a retrospective study of 69 patients who developed DPPB after the removal of colorectal polyps of ≤10 mm and underwent hemostatic colonoscopy at the Sixth Affiliated Hospital of Sun Yat-sen University (Guangzhou, China) between April 2013 and June 2021. Demographics, clinical variables, and colonoscopic features were collected independently. We applied univariate and multivariate analyses to assess factors associated with initial hemostatic success.ResultsGeneral colonoscopy without oral bowel preparation was successfully performed in all the patients, with a median duration of 23.9 (12.5–37.9) minutes. Among 69 patients, 62 (89.9%) achieved hemostasis after initial hemostatic colonoscopy and 7 (10.1%) rebled 2.7 ± 1.1 days after initial colonoscopic hemostasis and had rebleeding successfully controlled by one additional colonoscopy. No colonoscopy-related adverse events occurred. Multivariate analysis showed that management with at least two clips was the only independent prognostic factor for initial hemostatic success (odds ratio, 0.17; 95% confidence interval, 0.03–0.91; P = 0.04). All the patients who had at least two clips placed at the initial hemostatic colonoscopy required no further hemostatic intervention.ConclusionsColonoscopy is a safe, effective, and not too time-consuming approach for the management of patients with DPPB of small colorectal polyps and management with the placement of at least two hemoclips may be beneficial.

S267 Colonoscopy-Related Adverse Events in Patients With Abnormal Stool-Based Tests: A Systematic Review of Literature and Meta-Analysis of Outcomes

S267 Colonoscopy-Related Adverse Events in Patients With Abnormal Stool-Based Tests: A Systematic Review of Literature and Meta-Analysis of Outcomes

Continuous monitoring of colonoscopy performance in the Netherlands: first results of a nationwide registry.

To optimize colonoscopy quality, several performance measures have been developed. These are usually assessed without distinction between the indications for colonoscopy. This study aimed to assess the feasibility of linking two national registries (one for colonoscopy and one for adverse events of gastrointestinal endoscopies in the Netherlands), and to describe the results of colonoscopy quality per indication. This retrospective study was conducted with prospectively collected data of the Dutch Gastrointestinal Endoscopy Audit (DGEA) and the Dutch Registration of Complications in Endoscopy (DRCE). Data between 01-01-2016 and 01-01-2019 were analyzed. To calculate adverse event rates, data were linked at the level of endoscopy service. During the 3-year study period, 266 981 colonoscopies were recorded in DGEA. Of all indications, cecal intubation rate was highest in fecal immunochemical test (FIT)-positive screening colonoscopies (97.1 %), followed by surveillance (93.2 %), diagnostic (90.7 %), and therapeutic colonoscopies (83.1 %). The highest rate of adequate bowel preparation was observed in FIT-positive screening colonoscopies (97.1 %). A total of 1540 colonoscopy-related adverse events occurred (0.58 % of all colonoscopies). Bleeding and perforation and rates were highest for therapeutic (1.56 % and 0.51 %, respectively) and FIT-positive screening (0.72 % and 0.06 %, respectively) colonoscopies. The colonoscopy-related mortality was 0.006 %. This study describes the first results of the Dutch national colonoscopy registry, which was successfully linked to data from the national registry for adverse events of gastrointestinal endoscopies. In this large dataset, performance varied between indications. Our results emphasize the importance of defining benchmarks per indication in future guidelines.

Colonoscopy-related adverse events and mortality in an Italian organized colorectal cancer screening program.

Post-colonoscopy adverse events are a key quality indicator in population-based colorectal cancer screening programs, and affect safety and costs. This study aimed to assess colonoscopy-related adverse events and mortality in a screening setting. We retrieved data from patients undergoing colonoscopy within a screening program (fecal immunochemical test every 2 years, 50-69-year-olds, or post-polypectomy surveillance) in Italy between 2002 and 2014, to assess the rate of post-colonoscopy adverse events and mortality. Any admission within 30 days of screening colonoscopy was reviewed to capture possible events. Mortality registries were also matched with endoscopy databases to investigate 30-day post-colonoscopy mortality. Association of each outcome with patient-/procedure-related variables was assessed using multivariable analysis. Overall, 117 881 screening colonoscopies (66 584, 56.5 %, with polypectomy) were included. Overall, 497 (0.42 %) post-colonoscopy adverse events occurred: 281 (0.24 %) bleedings (3.69‰/0.68‰, operative/diagnostic procedures) and 65 (0.06 %) perforations (0.75‰/0.29‰, respectively). At multivariable analysis, bleeding was associated with polyp size (≥ 20 mm: odds ratio [OR] 16.29, 95 % confidence interval [CI] 9.38-28.29), proximal location (OR 1.46, 95 %CI 1.14-1.87), and histology severity (high risk adenoma: OR 5.6, 95 %CI 2.43-12.91), while perforation was associated with endoscopic resection (OR 2.91, 95 %CI 1.62-5.22), polyp size (OR 4.34, 95 %CI 1.46-12.92), and proximal location (OR 1.94, 95 %CI 1.12-3.37). Post-colonoscopy mortality occurred in 15 /117 881 cases (1.27/10 000 colonoscopies). In an organized screening program, post-colonoscopy adverse events were rare but not negligible. The most frequent event was post-polypectomy bleeding, especially after resection of large (≥ 20 mm) and proximal lesions.

The long-term outcomes and natural disease course of serrated polyposis syndrome: over 10 years of prospective follow-up in a specialized center

Serrated polyposis syndrome (SPS) is the most prevalent colonic polyposis syndrome known and is associated with a high risk of colorectal cancer (CRC) if left untreated. Treatment consists of clearance of the initial polyp burden, followed by lifelong stringent endoscopic surveillance. However, the long-term safety and efficacy of surveillance and the natural disease course after initial clearance have not been described in detail. We analyzed a single-center cohort of patients with SPS with over 10 years of prospective follow-up. Outcome measures were (1) CRC incidence, (2) postcolonoscopy adverse event rates, and (3) trends in polyp recurrence during endoscopic surveillance. The cohort included 142 patients who underwent a median of 6 colonoscopies with a median of 47 months of prospective follow-up after initial polyp clearance. During surveillance (every 1-2 years), 1 case of CRC occurred (5-year CRC incidence, 1.0%; 95% confidence interval, 0%-2.9%). During 447 surveillance colonoscopies with 1308 polypectomies, 1 episode of postpolypectomy bleeding, 1 postpolypectomy syndrome, and no perforations occurred (adverse event rate, 0.45% per colonoscopy). During up to 9 rounds of surveillance, no upward or downward trend in polyp recurrence was observed. In this prospective cohort with over 10 years of follow-up, endoscopic surveillance was effective and safe, with a low risk of CRC and colonoscopy-related adverse events. Furthermore, we show that the disease course of SPS is such that the polyp burden remains more or less equal during long-term surveillance, which advocates lifelong adherence to (personalized) surveillance guidelines and discourages de-intensifying surveillance intervals after multiple rounds of surveillance.

Outpatient facility volume, facility type, and the risk of serious colonoscopy-related adverse events in patients with comorbid conditions: a population-based study.

Patients with a chronic comorbidity or multiple comorbidities are at much greater risk of serious colonoscopy-related gastrointestinal (GI) adverse events relative to patients with no comorbidity. It is important to identify outpatient facilities that can effectively and safely provide colonoscopy to complex patients. To address this need, the association between outpatient facilities' complex care volume and type (ambulatory surgery center (ASC) and hospital outpatient department (HOPD)) and the risks of serious GI adverse events in colonoscopy patients with single and multiple chronic comorbidities were examined. Outpatient colonoscopies of 1,020,372 patients with single and multiple comorbidities were investigated, using a retrospective cohort study. Thirty-day hospitalizations due to colonic perforations and GI bleeding were examined. Ambulatory surgery and hospital discharge datasets from California, Florida, and New York for 2006-2009 were used. Higher complex care volume was associated with lower risks of adverse events in patients with comorbidities (OR 1.69; 95% CI [1.13, 2.54]). ASCs had higher risks of adverse events in patients with comorbidities relative to HOPDs (OR 2.85; 95% CI [2.40, 3.38]). Patients with single and multiple comorbid conditions, patients with systemic diseases, and complex patients of advanced age had higher risks of adverse events. Referring patients with single and multiple chronic comorbidities to facilities experienced in treating complex patients, or HOPDs, may reduce colonoscopy-related adverse events.

Benefits, harms and cost-effectiveness of cancer screening in Australia: an overview of modelling estimates

There are three government-funded population-based screening programs in Australia - the national breast cancer screening program (BreastScreen Australia), the National Cervical Screening Program (NCSP), and the National Bowel Cancer Screening Program (NBCSP). Options for early detection of other cancers (e.g. hepatocellular carcinoma and melanoma) are under investigation. This study provides an overview of the health benefits, harms and cost-effectiveness of population-level breast, cervical and colorectal cancer screening, targeted-risk screening for lung cancer and Lynch syndrome, and prostate specific antigen (PSA) testing in Australia. The study reviewed and, where possible, updated the estimated health benefits, harms and cost-effectiveness of screening approaches from modelling studies for four cancer types, PSA testing and Lynch syndrome testing in Australia. Costs are presented in 2018 Australian dollars. The renewed NCSP (for women not HPV-vaccinated) and the NBCSP were estimated to be cost-effective versus no screening; the cost-effectiveness ratio (CER) was $16 632 per life-year saved (LYS) for the NCSP, and $3380/LYS for the NBCSP. BreastScreen Australia was predicted to have a CER of $40 279/LYS-$65 065/LYS. In 2017, the NCSP transitioned to 5-yearly primary HPV testing with partial genotyping for HPV types 16 and 18 for women aged 25-74 years. Alongside vaccination, this change is predicted to prevent a further 587 cervical cancer deaths in 2018-2035, and have a favourable benefit-to-harm balance versus prior practice (biennial cytology testing for women aged 18-69 years). On average, the NBCSP (biennial screening using an immunochemical faecal occult blood test for people aged 50-74 years) is estimated to prevent 2519 colorectal cancer deaths and result in 350 colonoscopy-related adverse events annually. The inaccuracy of PSA testing as a screening tool impedes the capacity to conduct meaningful cost-effectiveness analyses at a population level, based on current evidence. Three annual low-dose computed tomography screens for lung cancer using the US National Lung Screening Trial selection criteria would not be cost-effective in Australia. A comprehensive cost-effectiveness evaluation of systematic proband testing, cascade testing and subsequent surveillance for Lynch syndrome in Australia is currently underway. Current evidence supports a favourable cost-effectiveness and benefit-to-harm balance for the NCSP and NBCSP. An updated cost-effectiveness and benefits-to-harms analysis for BreastScreen Australia is required. Carefully founded quantitative estimates of health benefits, harms and cost-effectiveness provide an important aid to policy decision making, and form the basis for developing decision aids to guide individual screening decisions. Opportunities exist for lung cancer screening, systematic Lynch syndrome testing and informed decision making about PSA testing. However, more evidence is required on risk assessment, targeting of screening tests, optimal referral pathways, managing potential harms and delivering services in a cost-effective framework.

A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial

BackgroundThe clinical benefit of early colonoscopy within 24 h of arrival in patients with severe acute lower gastrointestinal bleeding (ALGIB) remains controversial. This trial will compare early colonoscopy (performed within 24 h) versus elective colonoscopy (performed between 24 and 96 h) to examine the identification rate of stigmata of recent hemorrhage (SRH) in ALGIB patients. We hypothesize that, compared with elective colonoscopy, early colonoscopy increases the identification of SRH and subsequently improves clinical outcomes.MethodsThis trial is an investigator-initiated, multicenter, randomized, open-label, parallel-group trial examining the superiority of early colonoscopy over elective colonoscopy (standard therapy) in ALGIB patients. The primary outcome measure is the identification of SRH. Secondary outcomes include 30-day rebleeding, success of endoscopic treatment, need for additional endoscopic examination, need for interventional radiology, need for surgery, need for transfusion during hospitalization, length of stay, 30-day thrombotic events, 30-day mortality, preparation-related adverse events, and colonoscopy-related adverse events. The sample size will enable detection of a 9% SRH rate in elective colonoscopy patients and a SRH rate of ≥ 26% in early colonoscopy patients with a risk of type I error of 5% and a power of 80%.DiscussionThis trial will provide high-quality data on the benefits and risks of early colonoscopy in ALGIB patients.Trial registrationUMIN-CTR Identifier, UMIN000021129. Registered on 21 February 2016; ClinicalTrials.gov Identifier, NCT03098173. Registered on 24 March 2017.

A register-based study: adverse events in colonoscopies performed in Sweden 2001–2013

Objectives: The rates for colonoscopy-associated adverse events vary considerably worldwide. In Sweden, the figures are known to a limited extent. We assessed the frequency of severe colonoscopy-related adverse events and the impacts of different risk factors, including the use of general anaesthesia.Material and methods: This is a retrospective population-based cohort study of the colonoscopies performed during the years 2001–2013 on adults identified in the Swedish health registers. The rates for bleeding, perforation, splenic injury and 30-day mortality were calculated. Covariates for risks were assessed in a multivariate Poisson regression model.Results: There were 593,315 colonoscopies performed on the 426,560 individuals included in the study. The rates for colonoscopy-related bleeding and perforation were 0.17% and 0.11%, respectively. When polypectomy was performed, the rates were 0.53% for bleeding and 0.25% for perforation. There were 31 splenic injuries (1:20,000 colonoscopies) reported. The crude 30-day death rate for colonoscopy was 0.68%. Of those diagnosed with bleeding or perforation, 5.6% and 6.1% were dead within 30 days, respectively. The multivariate RR for perforation when general anaesthesia was employed was 2.65 (p < .001; 95%CI 1.71–4.12).Conclusions: The perforation rate seemed to be relatively high in an international perspective. General anaesthesia was associated with a significantly higher risk for perforation. Splenic injuries were more frequent than expected.

Patient-reported adverse events after colonoscopy in Norway

Background and aims Patient-reported outcome measures are increasingly important in healthcare. European guidelines have recommended inclusion of patient feedback to capture adverse events due to colonoscopy, but this is rarely implemented. Methods The Norwegian Quality Assurance network for endoscopy (Gastronet) collects patient-reported outcome for colonoscopies. Free-text comments on patient reports from January to December 2015 were characterized as positive or negative. All negative free-text comments were scrutinized for information that might suggest colonoscopy-related adverse events. We identified severe adverse events with and without admission to hospital. Results We included 16 552 outpatient colonoscopies performed at 21 hospitals. A total of 11 248 procedures (68 %) were accompanied by a patient feedback report, of which 2628 (23 %) had free-text comments (2196 [20 %] characterized as positive and 432 [3.8 %] as negative). These negative free texts on patient reports revealed 15 post-colonoscopy hospital admissions due to adverse events that had not been registered in the colonoscopy report. This increased the number of hospital admissions caused by adverse events from 3 (0.03 %) to 18 (0.16 %). In addition, there were 14 patient reports of severe events without hospital admission. Therefore, a total of 29 severe adverse events reported by patients were missed by conventional documentation in the colonoscopy form. Conclusion It is feasible to implement patient feedback as routine reporting to capture the full picture of colonoscopy-related adverse events. Some patients experience significant complications that are not recorded through any registries. Patient feedback forms should be tailored to capture adverse events after colonoscopy that are otherwise not easily disclosed.

Adverse Events during Bowel Preparation and Colonoscopy in Patients with Acute Lower Gastrointestinal Bleeding Compared with Elective Non-Gastrointestinal Bleeding

BackgroundThere are limited data on the safety of colonoscopy in patients with lower gastrointestinal bleeding (LGIB). We examined the various adverse events associated with colonoscopy in acute LGIB compared with non-GIB patients.MethodsEmergency hospitalized LGIB patients (n = 161) and age- and gender-matched non-GIB controls (n = 161) were selected. Primary outcomes were any adverse events during preparation and colonoscopy procedure. Secondary outcomes were five bowel preparation-related adverse events–hypotension, systolic blood pressure <100 mmHg, volume overload, vomiting, aspiration pneumonia and loss of consciousness–and four colonoscopy-related adverse events–including hypotension, perforation, cerebrocardiovascular events and sepsis.ResultsDuring bowel preparation, 16 (9%) LGIB patients experienced an adverse event. None of the LGIB patients experienced volume overload, aspiration pneumonia or loss of consciousness; however, 12 (7%) had hypotension and 4 (2%) vomited. There were no significant differences in the five bowel preparation-related adverse events between LGIB and non-GIB patients. During colonoscopy, 25 (15%) LGIB patients experienced an adverse event. None LGIB patient had perforation or sepsis; however, 23 (14%) had hypotension and 2 (1%) experienced a cerebrocardiovascular event. There was no significant difference in the four colonoscopy-related adverse events between LGIB and non-GIB patients. In addition, no significant difference in any of the nine adverse events was found among subgroups: patients aged ≥65 years, those with comorbidities, and those with antithrombotic drug use.ConclusionsAdverse events in bowel preparation and colonoscopy among acute LGIB patients were low. No significant difference was found in adverse events between LGIB and non-GIB patients. These adverse events were also low in elderly LGIB patients, as well as in those with co-morbidities and antithrombotic drug use, suggesting that colonoscopy performed during acute LGIB did not increase adverse events.