Baseline Features and Reasons for Nonparticipation in the Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) Study, a Colorectal Cancer Screening Trial.

Importance: The Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) randomized clinical trial sought to recruit 50 000 adults into a study comparing colorectal cancer (CRC) mortality outcomes after randomization to either an annual fecal immunochemical test (FIT) or colonoscopy. Objective: To (1) describe study participant characteristics and (2) examine who declined participation because of a preference for colonoscopy or stool testing (ie, fecal occult blood test [FOBT]/FIT) and assess that preference's association with geographic and temporal factors. Design, Setting, and Participants: This cross-sectional study within CONFIRM, which completed enrollment through 46 Department of Veterans Affairs medical centers between May 22, 2012, and December 1, 2017, with follow-up planned through 2028, comprised veterans aged 50 to 75 years with an average CRC risk and due for screening. Data were analyzed between March 7 and December 5, 2022. Exposure: Case report forms were used to capture enrolled participant data and reasons for declining participation among otherwise eligible individuals. Main Outcomes and Measures: Descriptive statistics were used to characterize the cohort overall and by intervention. Among individuals declining participation, logistic regression was used to compare preference for FOBT/FIT or colonoscopy by recruitment region and year. Results: A total of 50 126 participants were recruited (mean [SD] age, 59.1 [6.9] years; 46 618 [93.0%] male and 3508 [7.0%] female). The cohort was racially and ethnically diverse, with 748 (1.5%) identifying as Asian, 12 021 (24.0%) as Black, 415 (0.8%) as Native American or Alaska Native, 34 629 (69.1%) as White, and 1877 (3.7%) as other race, including multiracial; and 5734 (11.4%) as having Hispanic ethnicity. Of the 11 109 eligible individuals who declined participation (18.0%), 4824 (43.4%) declined due to a stated preference for a specific screening test, with FOBT/FIT being the most preferred method (2820 [58.5%]) vs colonoscopy (1958 [40.6%]; P < .001) or other screening tests (46 [1.0%] P < .001). Preference for FOBT/FIT was strongest in the West (963 of 1472 [65.4%]) and modest elsewhere, ranging from 199 of 371 (53.6%) in the Northeast to 884 of 1543 (57.3%) in the Midwest (P = .001). Adjusting for region, the preference for FOBT/FIT increased by 19% per recruitment year (odds ratio, 1.19; 95% CI, 1.14-1.25). Conclusions and Relevance: In this cross-sectional analysis of veterans choosing nonenrollment in the CONFIRM study, those who declined participation more often preferred FOBT or FIT over colonoscopy. This preference increased over time and was strongest in the western US and may provide insight into trends in CRC screening preferences.

Efficacy of Prophylactic Hemoclips in Prevention of Delayed Post-Polypectomy Bleeding in Patients With Large Colonic Polyps.

BACKGROUND & AIMS: The efficacy of prophylactic placement of hemoclips to prevent delayed bleeding after removal of large colonic polyps has not been established. We conducted a randomized equivalence study to determine whether prophylactic placement of hemoclips affects incidence of delayed post-polypectomy bleeding (PPB). METHODS: During elective colonoscopy performed at 4 Veterans Affairs Medical Centers, 1098 patients who had polyps ≥1 cm removed were randomly assigned to groups that received prophylactic hemoclips (n = 547) or no hemoclips (n = 551), from September 2011 through September 2018. Data on PPB (rectal bleeding resulting in hemoglobin decreases ≥2 g/dL, hemodynamic instability, colonoscopy, angiography, or surgery) within 30 days of colonoscopy (called delayed PPB) were collected during telephone interviews or hospital visits 7 and 30 days after colonoscopy. The primary outcome was the incidence of important post-polypectomy bleeding. RESULTS: Twelve patients in the hemoclip group (2.3%) and 15 patients in the no hemoclip group (2.9%) had important delayed PPB. There were no deaths, and no patients in either group required angiography or surgery. In intention-to-treat analysis, two 1-sided test's lower and upper confidence interval limits were -2.07 and 1.01, indicating that the data approached but did not meet equivalence criteria. On multiple logistic regression analysis, significant predictors of PPB included use of warfarin with bridging, thienopyridines, polyp size, and polyp location, but hemoclip placement did not associate with important delayed PPB. CONCLUSIONS: In a randomized trial, we found that prophylactic placement of hemoclips after removal of large colon polyps does not affect the proportion of important delayed PPB events, compared with no hemoclip placement. These findings call into question the widespread, expensive practice of routinely placing prophylactic hemoclips after polypectomy. ClinicalTrials.gov ID: NCT01647581.

Low rate of postpolypectomy bleeding among patients who continue thienopyridine therapy during colonoscopy.

BACKGROUND & AIMS: It is not clear whether the cardiovascular risk of discontinuing treatment with antiplatelet agents, specifically the thienopyridines, before elective colonoscopy outweighs the risks of postpolypectomy bleeding (PPB). We studied the rate of PPB in patients who continue thienopyridine therapy during colonoscopy. METHODS: We performed a prospective study of 516 patients not taking warfarin who received polypectomies during elective colonoscopies; 219 were receiving thienopyridines, and 297 were not (controls). The occurrence of immediate PPB and delayed PPB was recorded. Delayed PPB was categorized as clinically important if it resulted in repeat colonoscopy, hospitalization, or blood transfusion. RESULTS: Patients receiving thienopyridines were older and had significantly more comorbid diseases than controls; the mean number of polyps removed per patient was significantly higher (3.9 vs 2.9) in the thienopyridine group. Immediate PPB developed in 16 patients in the thienopyridine group (7.3%) and in 14 in the control group (4.7%, P = .25). Among patients who completed a 30-day follow-up analysis (96% of patients enrolled), clinically important, delayed bleeding occurred in 2.4% of patients receiving thienopyridines and in none of the controls (P = .01). All PPB events in both groups were resolved without surgery, angiography, or death. CONCLUSIONS: Although a significantly higher percentage of patients who continue thienopyridine therapy during colonoscopy and polypectomy develop clinically important delayed PPB than patients who discontinue therapy, the rate of PPB events is low (2.4%), and all are resolved without sequelae. The risk for catastrophic cardiovascular risks among patients who discontinue thienopyridine therapy before elective colonoscopies could therefore exceed the risks of PPB. ClinicalTrials.gov, Number NCT01647568.

Prone positioning of obese patients for colonoscopy results in shortened cecal intubation times: a randomized trial.

BACKGROUND: Obesity is a risk factor for colorectal cancer, and colonoscopy can be technically challenging in obese patients. It has been proposed (with little supporting data) that prone positioning of obese patients might facilitate a difficult colonoscopy. AIM: The aim of this study was to determine if starting colonoscopy in the prone position for obese patients decreases cecal intubation times. METHODS: This was a prospective, randomized study conducted at the North Texas VA Medical Center. Patients with a body mass index of ≥30 kg/m(2) undergoing elective colonoscopy were randomized 1:1 to either initial prone positioning or standard, left-lateral positioning. The outcome measurements were cecal intubation time, frequency of repositioning, sedative medications used, reports of pain, complications, and procedure tolerability. RESULTS: Fifty patients were randomized to have colonoscopy starting in the standard, left-lateral decubitus position, and 51 to the prone position. The average cecal intubation time for the standard group was 550 vs. 424 s in the prone group (p = 0.03). Patient repositioning was used in 28 % of patients in the standard group versus 8 % in the prone group (p = 0.009). There was no difference in subjective reports of pain between groups (p = 0.95) or in average pain scores (p = 0.79). Follow-up interviews were conducted in 93 % of patients, all of whom said that they would be willing to have repeat colonoscopy in the same position. CONCLUSIONS: Performance of colonoscopy in the prone position for obese patients results in significantly shorter cecal intubation times and decreased need for patient repositioning. Prone positioning is well accepted and does not significantly increase procedure-related discomfort.

The rate of post-polypectomy bleeding for patients on uninterrupted clopidogrel therapy during elective colonoscopy is acceptably low.

BACKGROUND: We do not routinely discontinue clopidogrel before colonoscopy because we have judged the cardiovascular risks of that practice to exceed the risks of post-polypectomy bleeding (PPB). AIMS: The aim of this study was to compare the rates of PPB for clopidogrel users and non-users. METHODS: We performed a retrospective, case-control study of patients who had colonoscopic polypectomy at our VA hospital from July 2008 through December 2009. We compared the frequency of delayed PPB (within 30 days) for patients on uninterrupted clopidogrel therapy with patients not taking clopidogrel. To minimize confounding from differences between groups in conditions that might contribute to PPB, propensity scoring was used to match clopidogrel users with controls based on numerous factors including age, aspirin use, number and size of polyps removed. RESULTS: A total of 1,967 patients had polypectomy during the study period; 118 were on clopidogrel and 1,849 were not. Logistic regression analysis revealed no significant difference in frequency of PPB between clopidogrel users and non-users (0.8% vs. 0.3%, P = 0.37, unadjusted OR = 2.63, 95% CI 0.31-22). Matched analyses using propensity scoring also revealed no significant difference in PPB rates between clopidogrel users and non-users (0.9% vs. 0%, P = 0.99). CONCLUSIONS: The delayed PPB rate for our patients on clopidogrel was less than 1%, and PPB rates did not differ significantly between users and non-users. Our conclusions are limited by differences in therapeutic methodology between the groups, and our findings are most applicable to small polyps (<1 cm). We speculate that cardiovascular risks of routinely discontinuing clopidogrel before elective colonoscopy may exceed any excess risk of PPB.

A comparison of palliative stenting or emergent surgery for obstructing incurable colon cancer.

BACKGROUND: Acute colonic obstruction because of advanced colonic malignancy is a surgical emergency. Our aim was to review our experience with self-expanding metal stents (SEMS) compared to emergent surgery as the initial therapy for the management of patients with incurable obstructing colon cancer. METHODS: A retrospective review of patients with obstructing colon cancer who underwent insertion of a SEMS (n = 53) or surgery (n = 70) from 2002 to 2008 was performed. The primary endpoint was relief of obstruction. Secondary endpoints include technical success of the procedure, duration of hospital stay, early and long-term complications, and overall survival. RESULTS: Both groups were similar in age, sex, and tumor distribution. Placement of SEMS was successful in 50/53 (94%) patients. Surgery was effective in relieving obstruction in 70/70 (100%) patients. Patients in the SEMS group have a significantly shorter median hospital stay (2 days) as compared to the surgery group (8 days) (P < 0.001). Patients with SEMS also had significantly less acute complications compared to the surgery group (8 vs. 30%, P = 0.03). The hospital mortality for the SEMS group was 0% compared to 8.5% in patients that underwent surgical decompression (P = 0.04). There was no difference in survival between the two groups (P = 0.76). CONCLUSIONS: In patients with colorectal cancer and obstructive symptoms, SEMS provide a highly effective and safe therapy when compared to surgery. In most patients with metastatic colorectal cancer and obstruction, SEMS provide a minimally invasive alternative to surgical intervention.

Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality.

BACKGROUND: Recent studies suggest that colonoscopies done in the morning have better-quality bowel preparations than those done in the afternoon. OBJECTIVE: We aimed to determine how the duration of the interval between the end of the preparation and the start of the colonoscopy affects preparation quality. DESIGN: We prospectively studied consecutive outpatients who had colonoscopies performed at our hospital within a 3-month period. The time of day when the colonoscopy started and the time interval from the last dose of preparation agent to the start of the colonoscopy were recorded. The endoscopist graded the quality of the preparation in the right side of the colon by using a 5-point visual scale. PATIENTS: We studied 378 patients (96% men, mean age 62.2 years) who received preparations of polyethylene glycol electrolyte-based (PEG) and sodium phosphate (SP) solution (71%), oral PEG and magnesium citrate (23%), or SP alone (6%). RESULTS: Compared with patients whose preparations were graded as 2/3/4 (fair/poor/inadequate), those whose preparations were graded as 0/1 (excellent/good) had a significantly shorter interval between the time of the last preparation agent dose and the start of the colonoscopy (P = .013). LIMITATIONS: We used a nonvalidated scale to assess the quality of bowel preparation. CONCLUSIONS: Bowel-preparation quality varies inversely with the duration of the interval between the last dose of the bowel-preparation agent and the start of colonoscopy. This interval appears to be a better predictor of bowel-preparation quality than the time of day when colonoscopy is performed.

The risk of acute myocardial infarction with etodolac is not increased compared to naproxen: a historical cohort analysis of a generic COX-2 selective inhibitor.

BACKGROUND: This study compares the risk of acute myocardial infarction among patients exposed to etodolac, naproxen, celecoxib, and rofecoxib. METHODS: A retrospective cohort study in 38 258 veteran patients (26 376 patient-years) measured the adjusted odds ratios of acute myocardial infarction during exposure to etodolac, naproxen, celecoxib, or rofecoxib. RESULTS: Diagnosis of acute myocardial infarction was confirmed in 100 patients who were exposed to a study nonsteroidal anti-inflammatory drug. Compared to naproxen, the increased risk of acute myocardial infarction was not significant for etodolac (OR = 1.32, P = .27), whereas celecoxib (OR = 2.18, 95% CI 1.09-4.35, P = .03) and rofecoxib (OR = 2.16, 95 CI 1.04-4.46, P = .04) were significant. A post hoc analysis indicates that patients with a prior history of acute myocardial infarction had a significant, 4.26-fold risk for another acute myocardial infarction if taking celecoxib or rofecoxib. CONCLUSION: Etodolac is not associated with a statistically increased risk of acute myocardial infarction compared to naproxen.

Through-the-scope, wire-guided esophageal dilation for the treatment of food impaction.

BACKGROUND: Acute esophageal food impaction (EFI) may be treated by endoscopic extraction of the food bolus either en bloc or in a piecemeal fashion. We have found this endoscopic extraction technique to be unsatisfactory. OBJECTIVE: Our purpose was to demonstrate the use of through-the-scope (TTS), wire-guided esophageal balloon dilation to treat EFI. DESIGN: Case reports defining the technique and results of esophageal balloon dilation to treat EFI. SETTING: Tertiary referral center. PATIENTS: Eleven patients presenting with EFI. INTERVENTIONS: Through-the-scope (TTS), wire-guided esophageal balloon dilation to relieve EFI. Main outcome measurements Endoscopic resolution of EFI. RESULTS: TTS, wire-guided esophageal balloon dilation successfully dislodged the EFI in all 11 patients. The procedure took <5 minutes to complete in all cases. There were no major procedure-related complications. LIMITATIONS: Small number of patients. CONCLUSIONS: We have found TTS, wire-guided esophageal balloon dilation to be a simple, quick, safe, and effective technique to treat EFI.

Five-year colon surveillance after screening colonoscopy.

BACKGROUND & AIMS: Outcomes of colon surveillance after colorectal cancer screening with colonoscopy are uncertain. We conducted a prospective study to measure incidence of advanced neoplasia in patients within 5.5 years of screening colonoscopy. METHODS: Three thousand one hundred twenty-one asymptomatic subjects, age 50 to 75 years, had screening colonoscopy between 1994 and 1997 in the Department of Veterans Affairs. One thousand one hundred seventy-one subjects with neoplasia and 501 neoplasia-free controls were assigned to colonoscopic surveillance over 5 years. Cohorts were defined by baseline findings. Relative risks for advanced neoplasia within 5.5 years were calculated. Advanced neoplasia was defined as tubular adenoma greater than > or =10 mm, adenoma with villous histology, adenoma with high-grade dysplasia, or invasive cancer. RESULTS: Eight hundred ninety-five (76.4%) patients with neoplasia and 298 subjects (59.5%) without neoplasia at baseline had colonoscopy within 5.5 years; 2.4% of patients with no neoplasia had interval advanced neoplasia. The relative risk in patients with baseline neoplasia was 1.92 (95% CI: 0.83-4.42) with 1 or 2 tubular adenomas <10 mm, 5.01 (95% CI: 2.10-11.96) with 3 or more tubular adenomas <10 mm, 6.40 (95% CI: 2.74-14.94) with tubular adenoma > or =10 mm, 6.05 (95% CI: 2.48-14.71) for villous adenoma, and 6.87 (95% CI: 2.61-18.07) for adenoma with high-grade dysplasia. CONCLUSIONS: There is a strong association between results of baseline screening colonoscopy and rate of serious incident lesions during 5.5 years of surveillance. Patients with 1 or 2 tubular adenomas less than 10 mm represent a low-risk group compared with other patients with colon neoplasia.

Colorectal cancer screening and surveillance.

Screening and surveillance substantially reduce both the incidence and mortality of colorectal cancer. Screening of normal-risk individuals may be accomplished by several methods, including fecal occult blood testing, fiberoptic sigmoidoscopy, double contrast barium enema, and colonoscopy. New technologies for screening are being developed, such as fecal immunochemical testing for blood,fecal DNA testing, and virtual colonoscopy. Patients at increased risk for colorectal cancer, such as those with a positive family history, previous adenomatous polyps or cancer, and inflammatory bowel disease, should be offered more intensive evaluation and surveillance.

Recurrent bleeding from peptic ulcer associated with adherent clot: a randomized study comparing endoscopic treatment with medical therapy.

BACKGROUND: Endoscopic therapy reduces the recurrence of bleeding from actively bleeding peptic ulcers and those with visible vessels. However, the use of endoscopic therapy for ulcers with adherent clots remains controversial. The purpose of this study was to determine whether removal of clot from an ulcer and endoscopic therapy reduces the frequency of recurrent bleeding. METHODS: Patients with acute upper GI bleeding from peptic ulcers with adherent clots and no active bleeding were enrolled in a multicenter study. At each center patients were stratified for age, use of nonsteroidal anti-inflammatory drugs, and ulcer location, and were randomized to endoscopic or medical management. Endoscopic therapy consisted of injection of the base of the adherent clot with a solution of epinephrine and mechanical removal of the clot. The base of the ulcer and any stigmata of bleeding were then coagulated until cavitation and adequate coagulation were obtained. Patients in both groups received standard medical therapy for peptic ulcer. Patients were evaluated for recurrence of bleeding for 1 month. RESULTS: Fifty-six patients were enrolled. Rates of recurrent bleeding were 34.3% (12/35) in the medical treatment arm versus 4.8% (1/21) in the endoscopic treatment arm (p < 0.02). CONCLUSIONS: In patients with GI bleeding caused by gastric or duodenal ulcers with an adherent clot found on endoscopy, endoscopic therapy with injection of the base of the clot, clot removal, and heat probe coagulation significantly reduces the rate of recurrent bleeding compared with medical therapy alone.