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PubMed1994

Effect of music therapy on state anxiety in patients undergoing flexible sigmoidoscopy.

PURPOSE: Patient anxiety related to flexible sigmoidoscopy can negatively affect acceptability and compliance with screening protocol, complicate and prolong procedure time, and potentially result in prematurely aborted procedures. Music has been recognized through research as a safe, inexpensive, and effective nonpharmaceutical anxiolitic agent. METHODS: An experimental study was performed on 50 adults scheduled for outpatient sigmoidoscopy. The control group received standard sigmoidoscopy protocol. Subjects in the experimental group received the standard protocol with the addition of listening to music throughout the procedure. State-Trait Anxiety Inventory (STAI) measurements were performed on all subjects before and postsigmoidoscopy. Physiologic recordings of heart rate and mean arterial pressure were recorded before and during the procedure. RESULTS: Patients who listened to self-selected music tapes during the procedure had significantly decreased STAI scores (P < 0.002), heart rates (P < 0.03), and mean arterial pressures (P < 0.001) in comparison to the control subjects. CONCLUSION: The results of the study indicate that music is an effective anxiolitic adjunct to flexible sigmoidoscopy.

Adult↗
PubMed2005

History of negative colorectal endoscopy and risk of rectosigmoid neoplasms at screening flexible sigmoidoscopy.

BACKGROUND AND AIMS: Screening sigmoidoscopy can reduce incidence of colorectal cancer and mortality. The optimal re-screening interval has not yet been defined. This study is aimed at estimating the risk of distal advanced adenomas (diameter >/=10 mm, villous component >20%, high-grade dysplasia) and cancer at screening flexible sigmoidoscopy in subjects aged 55-64 years who reported pre-screening negative colorectal endoscopy. PATIENTS: Eight thousands two hundred two subjects aged 55-64 years who underwent screening flexible sigmoidoscopy within the SCORE trial in Italy and who were able to report their previous history of colorectal endoscopy. RESULTS: Eight hundred eighty three of 8,202 subjects (10.8%) reported at least one prescreening negative endoscopy: among them, after 3-5 years, 6-10 years and >10 years intervals between last reported examination and screening endoscopy, the Absolute Risk of advanced adenomas was 1.5%, 0.9% and 0.9%; one cancer was detected (0.1%). Among the 7,319 subjects who did not report prescreening endoscopy the risks of advanced adenoma and cancer were 3.2% and 0.4%, respectively. Subjects with a previous colorectal examination had a 65% decreased risk of advanced adenomas (OR=0.35, 95%CI 0.18-0.66) and a 71% decreased risk of cancer (OR=0.29, 95%CI 0.04-1.12) as compared to those who did not. For subjects without family history of colorectal cancer the statistically significant decrease of the risk persisted up to ten years. The observed benefit seems not to apply to subjects with family history of colorectal cancer. CONCLUSIONS: Our results are consistent with the hypothesis that the interval between screening sigmoidoscopies could be safely expanded beyond 5 years for subjects without specific risk factors for colorectal cancer.

Adenoma, Villous↗
PubMed2006

A prospective randomized single-blind comparison of three methods of bowel preparation for outpatient flexible sigmoidoscopy.

BACKGROUND: Preparation for outpatient flexible sigmoidoscopy using a self-administered phosphate enema is the standard practice in our unit, but it provides acceptable bowel preparation in only 80% of patients. This study compared two methods of bowel preparation with the current standard in an attempt to improve efficacy and acceptability. METHODS: From January to September 2003, patients scheduled for out-patient flexible sigmoidoscopy were prospectively randomized to 3 groups: group 1: one Fleet enema 2 h pre-procedure; group 2: two Fleet enemas, one on the evening prior to sigmoidoscopy and one 2 h pre-procedure; group 3: lactulose 30 ml orally 48 and 24 h prior to sigmoidoscopy, plus a single Fleet enema 2 h pre-procedure. A patient questionnaire was used to assess side effects and tolerance. The endoscopists questionnaire assessed the indication for the procedure, quality of preparation, depth of insertion, and pathological findings identified. Power calculations were based on the 80% acceptable preparation rate obtained using a single enema. RESULTS: For this study, 305 patients were randomized to the three groups. Patient data were available for 261 patients (group 1 = 105; group 2 = 81; group 3 = 75), and endoscopist data were available for 251 patients (group 1 = 97; group 2 = 79; group 3 = 75). No difference was noted between the groups with regard to age, gender, procedure indication, grade of endoscopist, or patient acceptability variables (ease of use: p = 0.09; assistance required: p = 0.11; cramps experienced: p = 0.84; alternative method: p = 0.25). There was no significant difference between the groups in terms of depth of insertion (p = 0.42-chi-squared test) or abnormalities noted (p = 0.34-chi-squared test). Nor was there any difference in the quality of preparation of patients in group 1 versus group 2 (p = 0.39-Fishers exact test) or group 1 versus group 3 (p = 0.13-Fishers exact). However, lactulose + Fleet resulted in significantly fewer patients with acceptable preparation compared with those who administered two Fleet enemas (p = 0.02- Fishers exact test). CONCLUSIONS: The addition of a Fleet enema or oral lactulose over and above a single Fleet enema gives no significant improvement in the acceptability or efficacy of bowel preparation.

Adult↗
PubMed2004

Informed consent for screening sigmoidoscopy in a Veterans Administration population.

PURPOSE: This study was performed to test the hypotheses that current consent methods may not convey the data that we imagine that they do, and that many patients may not want the data that we believe that we ought to provide. We also argue that excessive and unthinking emphasis on informed consent documentation may ignore real and important issues. METHODS: Fifty-nine male patients consecutively scheduled for screening sigmoidoscopy were interviewed before and after the procedure in a tertiary care academic health center. Chi-squared analysis was used to determine if the three independent variables of ethnicity, educational level, and previous sigmoidoscopy experience were able to discriminate various components of the informed consent process. RESULTS: Thirty-nine percent of patients could describe no indication other than doctor recommendation for the procedure. Although 86 percent of patients had heard of the word "polyp," 16 percent could not define it. Fifteen percent of patients could not pick out from a list subsequent steps to be taken in case of an abnormal examination. Although most patients could describe discomforts associated with the procedure, only 19 percent of patients mentioned bleeding and perforation as possible complications. Only 5 percent of patients knew any alternatives to sigmoidoscopy. No patient could explain risks and benefits of alternatives. Eighty-eight percent of patients could not identify their endoscopist, but this only bothered 13 percent. Ninety-three percent of patients were given an opportunity to ask questions, but only 22 percent actually did so. All patients signed the consent form, but only 14 percent of patients actually read all of it. Most patients, 97 percent, thought that they had enough information to proceed with the endoscopy. CONCLUSIONS: By traditional and classic standards, the patients in this study did not give informed consent. Yet, surprisingly, despite this lack of informed consent, most of the patients failed to ask further questions of their physicians and claimed that they had sufficient information to proceed with the procedure. This was the case across the three independent variables of ethnicity, educational level, and previous sigmoidoscopy experience.

Aged↗
PubMed2006

Impact of a family history of colorectal cancer on the prevalence of advanced adenomas of the rectosigmoid colon at flexible sigmoidoscopy in 3147 asymptomatic patients.

Flexible sigmoidoscopy is advised as a screening test for colorectal cancer for persons with a family history of late-onset colorectal cancer. The expected outcome for this approach is not well established. We designed a large, prospective study of an unselected population to assess the impact of a family history of one first-degree relative with colorectal cancer on the prevalence of advanced adenomas at screening flexible sigmoidoscopy. We evaluated 8121 patients referred for flexible sigmoidoscopy between 1997 and 1999 and 3147 patients met the inclusion criteria. The 3147 patients were divided into 210 with a family history of colorectal cancer and 2937 without a family history and analyzed for differences in the prevalence of advanced adenomas. Of the 210 with a family history, 3 had an advanced adenoma of the rectosigmoid colon (1.4%) Of the 2937 without a family history, 52 had an advanced adenoma of the rectosigmoid colon (1.8%), including 2 cancers. These differences were not significant. In conclusion, a family history of colorectal cancer had no impact on the prevalence of advanced adenomas in asymptomatic patients at screening flexible sigmoidoscopy. The prevalence rates for advanced adenomas and carcinomas of the rectosigmoid colon were low.

Adenoma↗
PubMed1986

Training resident physicians in fiberoptic sigmoidoscopy. How many supervised examinations are required to achieve competence?

Twenty-five resident physicians performed 495 fiberoptic sigmoidoscopic examinations that were graded for overall skill according to a six-point competence scale. In general, 24 to 30 examinations were required to become competent at fiberoptic sigmoidoscopy. Trainees with prior rigid sigmoidoscopy experience achieved competence more quickly than those with no prior rigid sigmoidoscopy experience. As experience increased, unassisted insertion distance and luminal visualization increased, insertion time and assisted time decreased, and management scores and percent correct diagnoses improved. Trainees detected 93 to 100 percent of polyps and cancers viewed by the experienced sigmoidoscopist once competence was achieved. These data indicate that programs for training primary care physicians in fiberoptic sigmoidoscopy are feasible, help define the number of examinations required to become competent, and indicate that such trainees should be effective in cancer screening.

Clinical Competence↗
PubMed1988

Role of sigmoidoscopy in screening for colorectal cancer: a critical review.

The use of sigmoidoscopy as a screening method for colorectal cancer is controversial. Evidence regarding its efficacy is reviewed critically, with special attention given to potential biases in screening studies. The vast majority of studies are uncontrolled and without follow-up information and thus shed little light on the actual benefits of sigmoidoscopy. Two uncontrolled studies with follow-up and one randomized trial suggest a colorectal cancer mortality reduction because of the use of sigmoidoscopy, but all three studies have major shortcomings. The authors conclude that the currently available data are insufficient to establish a national recommendation for screening with sigmoidoscopy. To establish such a recommendation, a properly conducted randomized trial with colorectal cancer mortality as an outcome is needed.

Clinical Trials as Topic↗
PubMed1994

The yield of a second screening flexible sigmoidoscopy in average-risk persons after one negative examination.

BACKGROUND/AIMS: The American Cancer Society recommends that asymptomatic persons aged > or = 50 years undergo sigmoidoscopy every 3-5 years. However, the yield of a second examination 3 years later in persons who are initially negative is unknown. The aim of this study was to determine the yield of a second flexible sigmoidoscopy in average-risk persons aged > or = 50 years after an initial negative examination. METHODS: Two hundred fifty-nine asymptomatic, average-risk persons who had undergone a negative screening flexible sigmoidoscopy examination at age > or = 50 years underwent a second examination at least 2 years later (mean, 3.4 years). RESULTS: The second examination found adenomas in 15 (6%) screenees, but no cancers or large (> 1 cm) or severely dysplastic adenomas were detected. Persons aged > or = 60 years at the time of the second examination were more likely (10%) to have adenomas than those < 60 years (3%) (odds ratio, 3.76; 95% confidence interval, 1.17-12.2), but no advanced lesions were found in persons aged > or = 60 years. CONCLUSIONS: These data suggest that the American Cancer Society should consider changing its recommendation for screening flexible sigmoidoscopy in asymptomatic, average-risk persons to 5-year intervals after a negative examination.

Adenoma↗
PubMed1993

Prevention of colorectal cancer by once-only sigmoidoscopy.

There is no national screening programme for colorectal cancer in the UK despite the fact that the annual death toll from this disease exceeds that of breast and cervical cancer. Faecal occult blood testing (FOBT) is under evaluation for screening, but screening by sigmoidoscopy is not considered viable. This situation contrasts with the USA where both annual FOBT and screening by flexible sigmoidoscopy every 3 to 5 years are recommended from 50 years old. We seek to demonstrate that most of the benefit from the US screening policy would accrue from a single flexible sigmoidoscopy examination at age 55 to 60 years with appropriate colonoscopic surveillance for the 3% to 5% found to have high-risk adenomas (> or = 1 cm or villous histology). If applied nationally, this screening regimen could prevent about 5500 colorectal cancer cases and 3500 deaths in the UK each year, thus saving 40,000 years of life. We estimate that there would be little net cost to the National Health Service because savings obtained from treating fewer patients would largely offset the cost of screening. We recommend that a randomised trial to evaluate screening by single flexible sigmoidoscopy should start without delay. Such a trial would involve about 120,000 participants, and 15 years of follow-up would be required to obtain a clear answer on mortality, although information on incidence reduction would be available sooner.

Adult↗
PubMed2006

Is the type of test used for mass colorectal cancer screening a determinant of compliance? A cluster-randomized controlled trial comparing fecal occult blood testing with flexible sigmoidoscopy.

BACKGROUND: The efficacy of colorectal cancer screening has been proved, and three different screening tests are recommended by international guidelines: the faecal occult blood test, flexible sigmoidoscopy and colonoscopy. While the effectiveness of a screening program depends on the compliance obtained, the role of the type of test on compliance has not yet been sufficiently studied. AIMS: To measure the effect of the type of screening test used, i.e. faecal occult blood test or flexible sigmoidoscopy, on the compliance to colorectal cancer screening programs. SUBJECTS AND METHODS: A cluster-randomized two-arm trial was conducted. We randomly assigned 20 GP's practices that had an average of 150 patients between 50 and 74 years old. RESULTS: 1449 individuals were referred to faecal occult blood test and 1538 to flexible sigmoidoscopy. The faecal occult blood test obtained higher compliance: 17.2% (95%CI 12.5-25.7) versus 7.0% (95%CI 5.7-9.0). The socio-economic status was an effect modifier of the test type: the effect of the type of test was smaller in low socioeconomic classes. CONCLUSIONS: The type of screening test used for colorectal cancer is a determinant of participation. In a low compliance area, better compliance will result from offering the faecal occult blood test than from the flexible sigmoidoscopy.

Aged↗
PubMed2001

Achieving quality in flexible sigmoidoscopy screening for colorectal cancer.

BACKGROUND: Sigmoidoscopy screening, which can dramatically reduce colorectal cancer mortality, is supported increasingly by physicians and payers, and is likely to be performed more frequently in the future. As more physicians and nonphysician medical personnel learn how to perform this procedure, and with attention to quality standards, the overall impact of sigmoidoscopy screening may improve. This review describes elements that characterize high-quality examinations and identifies resources for in-depth information on performing flexible sigmoidoscopy. METHODS: The domains of quality were identified from textbooks, articles, and the professional opinions of gastroenterologists and primary care physicians. Information was obtained from MEDLINE, bibliographies in recent articles, medical professional organizations, equipment manufacturers' representatives, and focus groups of primary care physicians. RESULTS: Nine domains of quality are identified and discussed: training, logistical start-up, patient interaction, bowel preparation, examination technique, lesion recognition, complications, reporting, and processing (equipment cleaning and disinfection). CONCLUSIONS: Persons learning how to perform and to implement flexible sigmoidoscopy may use this information to help ensure the quality of screening examinations.

Colorectal Neoplasms↗
PubMed1996

Potential costs of flexible sigmoidoscopy-based colorectal cancer screening.

BACKGROUND & AIMS: Increasing evidence shows that periodic screening by flexible sigmoidoscopy with appropriate referral of patients with adenomas to colonoscopy could substantially decrease colorectal cancer mortality rates. Estimates of the complete cost of such screening are needed. The aim of this study was to estimate the annual costs of periodic screening of Americans 50 years and older by flexible sigmoidoscopy with referral of subjects with adenomas to colonoscopy. METHODS: Cost analysis of flexible sigmoidoscopy, followed by colonoscopy as warranted, in U.S. population cohorts reaching age 50 each year from 1995 to 2010 was performed. Total yearly costs of repeat screening and surveillance examinations at American Cancer Society-recommended and other intervals were determined. RESULTS: With screening and surveillance intervals of 3 years, annual costs for the cohort of individuals turning 50 in 1995 would increase to $553 million by 2010. Annual costs for the entire population 50 years of age and older could increase by 2010 to nearly $20 billion. CONCLUSIONS: The cost of flexible sigmoidoscopy-based screening for colorectal cancer could vary as much as threefold depending on the protocol chosen.

Colorectal Neoplasms↗
PubMed1999

Effectiveness and patient satisfaction with screening flexible sigmoidoscopy performed by registered nurses.

BACKGROUND: Our aim was to compare the effectiveness and patient satisfaction with flexible sigmoidoscopy performed by a registered nurse, general surgeons, and gastroenterology fellows. METHODS: Consecutive outpatients referred for sigmoidoscopy were assigned to have the procedure performed by the first available provider. Depth of insertion of the sigmoidoscope, complications, duration of the procedure, and percentage of patients with adenomas were recorded. After the procedure, patients completed a validated patient satisfaction questionnaire. RESULTS: Mean depth of insertion was less for general surgeons compared with the nurse and gastroenterology fellows (50 vs 53 vs 54 cm, respectively; p = 0.01). Mean duration of procedure was longer for the nurse compared with general surgeons and gastroenterology fellows (8.3 vs 7.6 vs 6.8 min, respectively; p = 0.0001). Percentage of patients with adenomas was similar among patients who underwent sigmoidoscopy by the endoscopists (7% vs 8% vs 9%; p = 0.81). No differences were detected between endoscopists for overall satisfaction (p = 0.60), technical skills of the endoscopist (p = 0.58), communication skills of the endoscopist (p = 0.61), or interpersonal skills of the endoscopist (p = 0.59). CONCLUSION: No clinically significant differences in effectiveness or patient satisfaction were detected with flexible sigmoidoscopy performed by a registered nurse, general surgeons, or gastroenterology fellows.

Adult↗
PubMed2003

Costs of flexible sigmoidoscopy screening for colorectal cancer in the United Kingdom.

OBJECTIVES: Colorectal cancer is one of the most commonly occurring cancers in industrialized countries, yet appears to be amenable to screening. Amongst the many possible protocols is once-only screening by means of flexible sigmoidoscopy. This protocol is currently being investigated in a UK multicenter trial and the study provides estimates of the expected resource costs. METHODS: The direct health care costs of sigmoidoscopy and of all subsequent procedures were estimated from an audit of resource use of approximately 40,000 patients at thirteen centers. Patient-borne costs were estimated from the results of surveys conducted at twelve of these centers. RESULTS: The health service costs of a flexible sigmoidoscopy was estimated at pounds 56. The total costs of screening (including private costs) averaged pounds 82 per person screened, although costs varied by center. The total health service costs of screening and subsequent management averaged approximately pounds 91 per person screened, again with variations between centers. CONCLUSIONS: Even within a strict trial protocol, intercenter variation in costs can be detected, ascribable to variability in local management practices, local yield, and local patient-borne costs. Other recent estimates of flexible sigmoidoscopy costs vary widely. As these costs form the basis of technology assessment simulation models which, in turn, inform policy obtaining realistic cost estimates within the appropriate health care setting is of paramount importance.

Colorectal Neoplasms↗
PubMed2002

Racial differences in use of colonoscopy, sigmoidoscopy, and barium enema in Medicare beneficiaries.

Colorectal cancer is often diagnosed at a later stage in blacks. We wanted to know if racial differences existed in the use of tests for detection of colorectal cancer. A 5% random sample was obtained of all Medicare beneficiaries with Part B coverage, aged 65 years and older and classified as white or black race. The numbers of colonoscopies, flexible sigmoidoscopies, and barium enemas were determined from the Physician/Supplier file. Blacks were 18% less likely to receive colonoscopy and 39% less likely to receive flexible sigmoidoscopy after controlling for age, sex, income, and access to care in a multivariable logistic regression model. Barium enema was not significantly different between the races. Black men had 25% lower use of colonoscopy and 50% decreased use of flexible sigmoidoscopy. Blacks receive less colonoscopy and flexible sigmoidoscopy than whites. Black men are particularly vulnerable to the under-use of these tests.

Black or African American↗
PubMed1999

Difficult or incomplete flexible sigmoidoscopy: implications for a screening programme.

BACKGROUND: Pilot studies are currently underway to investigate the use of flexible sigmoidoscopy as a screening tool for colorectal cancer. Estimates of the sensitivity of this investigation in detecting adenomas and carcinomas frequently assume a complete examination to 60 cm in all cases. This study seeks to determine the depth of insertion of flexible sigmoidoscopy in asymptomatic volunteers, and to examine the causes and implications of an incomplete examination. METHODS: A prospective study of flexible sigmoidoscopy in asymptomatic volunteers was conducted. The maximum depth of insertion was measured in all cases, and a database compiled of patient characteristics, discomfort and endoscopic difficulty. RESULTS: Independent risk factors for reduced depth of insertion were female sex, previous abdominal surgery in females, high expectation of pain in females and poor bowel preparation. The procedure was considered difficult in 33% of cases. CONCLUSIONS: Estimates of the efficacy of flexible sigmoidoscopy as a colorectal cancer screening modality should take into account the relatively high rate of incomplete studies, particularly in women.

Adenoma↗
PubMed2003

Predictors of advanced proximal neoplasia in persons with abnormal screening flexible sigmoidoscopy.

BACKGROUND & AIMS: The relationship between distal and proximal colonic findings is uncertain. Thus, there is no consensus on which findings on screening flexible sigmoidoscopy should trigger colonoscopy. METHODS: We analyzed data from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial to assess the relationship between distal and proximal colonic findings. RESULTS: A total of 8802 subjects had an abnormal baseline sigmoidoscopy and colonoscopy follow-up. Subjects with <10-mm single or multiple tubular adenomas had similar risks for advanced proximal neoplasia as subjects with hyperplastic polyps or other benign lesions (3%-5%). Subjects with large (>or=10 mm), villous, or severely dysplastic distal adenomas had similarly elevated risks for advanced proximal neoplasia (11%-12%). Multivariate logistic modeling showed a significantly increased risk for advanced proximal neoplasia associated with the presence of a large tubular (odds ratio [OR], 2.6; 95% confidence interval [CI], 2.0-3.4) or villous distal adenoma (OR, 2.7; 95% CI, 2.1-3.5) but not with the presence of one (OR, 1.05; 95% CI, 0.8-1.3) or multiple (OR, 0.8; 95% CI, 0.5-1.2) <10-mm tubular distal adenomas. CONCLUSIONS: Among subjects with a polypoid lesion on screening flexible sigmoidoscopy, those with small tubular distal adenomas are at similar risk for advanced proximal neoplasia as those without distal adenomas. Subjects with a large, villous, or dysplastic distal adenoma are at increased risk. A strategy that encourages individuals with small tubular adenomas on sigmoidoscopy to undergo follow-up colonoscopy and excludes those with nonadenomatous lesions is of questionable validity, because both groups are at similar risk for advanced proximal neoplasia.

Adenoma↗
PubMed2004

The incidence of colorectal cancer following a negative screening sigmoidoscopy: implications for screening interval.

BACKGROUND & AIMS: Current guidelines recommend a 5-year interval for colorectal cancer (CRC) screening by sigmoidoscopy. However, the optimal screening interval is uncertain. We estimated the annual incidence of distal and proximal CRC in the first 5 years following a negative sigmoidoscopy examination to gauge the potential benefit of rescreening in <5 years. METHODS: A cohort of 72,483 participants in the Colon Cancer Prevention program of Kaiser Permanente of Northern California (KP) was defined using computerized databases. Men and women aged 50 years and older who had a negative screening flexible sigmoidoscopy examination between 1994 and 1996 and were considered not to be at high risk for developing CRC were included. Subjects were censored at the time of diagnosis (for cases), death, termination of KP membership, or subsequent colon examination. RESULTS: Thirty cases of distal and 80 cases of proximal CRC occurred. Age-adjusted incidence rates of distal CRC ranged from a low of 2.8 per 100,000 person-years in the first year of follow-up to a high of 13.0 per 100,000 in the fourth year (rate difference, 10.2; 95% confidence interval, 1.1-19.3). However, for the entire follow-up period, incidence of distal CRC remained much lower than age-adjusted rates of 70.6 in the general population (Surveillance, Epidemiology, and End Results registry). The incidence of proximal CRC was also decreased modestly over population rates of disease. CONCLUSIONS: Screening by sigmoidoscopy more frequently than every 5 years would likely lead, at best, to only modest improvements as compared with a 5-year screening interval.

Aged↗