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Booster medication to achieve capsule excretion in colon capsule endoscopy: a randomized controlled trial of three regimens.

ABSTRACT: Background and study aims ?To achieve a complete colon capsule endoscopy, the entire colon must be visualized, clean and filled with clear fluids. The primary aim was to compare three booster regimens in colon capsule endoscopy in achieving capsule excretion within recording time. Secondary aims were quality of bowel cleansing and completion rate (both adequate cleansing and capsule excretion). Patients and methods ?Patients scheduled for follow-up colonoscopy due to previous neoplastic findings or familial history of colorectal cancer aged 18 to 70 years were eligible. Bowel preparation was 2-L split doses of polyethylene glycol. Patients were randomized to three booster regimens of either polyethylene glycol (Group A), sulfate-based solution (Group B) or polyethylene glycol with iodine oral contrast (Group C). Results ?One hundred eighty participants were included and randomized into three groups of 60.?Capsule excretion was 70?% (95?% CI: 58?-?80) in Group A, 73?% (95?% CI: 61?-?83) in Group B and in 68?% (95?% CI: 56?-?79) in Group C, no statistically significant differences. Bowel cleansing grade was statistically significant better in Group B compared to Group A ( P ?=?0.03), but there were no statistically significant differences between Groups C and A ( P ?=?0.40). Complete examination rate was 65?% (95?% CI: 53?-?77), 72?% (95?% CI: 61?-?83) and 62?% (95?% CI: 50?-?74) in Group A, B and C respectively, not statistically significant different. Conclusions ?Sulfate-based solution resulted in statistically significant better bowel cleansing compared to polyethylene glycol. Overall the excretion and completion rate was suboptimal. Achieving a high completion rate using patient-tolerable and low-risk compounds is still a challenge.

SUBMITTER: Kroijer R

PROVIDER: S-EPMC6221809 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Booster medication to achieve capsule excretion in colon capsule endoscopy: a randomized controlled trial of three regimens.

Kroijer Rasmus R Dyrvig Anne-Kirstine AK Kobaek-Larsen Morten M Støvring Jens Overgaard JO Qvist Niels N Baatrup Gunnar G

Endoscopy international open 20181107 11

<b>Background and study aims</b> To achieve a complete colon capsule endoscopy, the entire colon must be visualized, clean and filled with clear fluids. The primary aim was to compare three booster regimens in colon capsule endoscopy in achieving capsule excretion within recording time. Secondary aims were quality of bowel cleansing and completion rate (both adequate cleansing and capsule excretion). <b>Patients and methods</b> Patients scheduled for follow-up colonoscopy due to previous neopl ...[more]

PMID: 30410958

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Project description:To assess the cleansing efficacy and safety of a new Colon capsule endoscopy (CCE) bowel preparation regimen.This was a multicenter, prospective, randomized, controlled study comparing two CCE regimens. Subjects were asymptomatic and average risk for colorectal cancer. The second generation CCE system (PillCam® COLON 2; Medtronic, Yoqneam, Israel) was utilized. Preparation regimens differed in the 1st and 2nd boosts with the Study regimen using oral sulfate solution (89 mL) with diatrizoate meglumine and diatrizoate sodium solution ("diatrizoate solution") (boost 1 = 60 mL, boost 2 = 30 mL) and the Control regimen oral sulfate solution (89 mL) alone. The primary outcome was overall and segmental colon cleansing. Secondary outcomes included safety, polyp detection, colonic transit, CCE completion and capsule excretion ? 12 h.Both regimens had similar cleansing efficacy for the whole colon (Adequate: Study = 75.9%, Control = 77.3%; P = 0.88) and individual segments. In the Study group, CCE completion was superior (Study = 90.9%, Control = 76.9%; P = 0.048) and colonic transit was more often < 40 min (Study = 21.8%, Control = 4%; P = 0.0073). More Study regimen subjects experienced adverse events (Study = 19.4%, Control = 3.4%; P = 0.0061), and this difference did not appear related to diatrizoate solution. Adverse events were primarily gastrointestinal in nature and no serious adverse events related either to the bowel preparation regimen or the capsule were observed. There was a trend toward higher polyp detection with the Study regimen, but this did not achieve statistical significance for any size category. Mean transit time through the entire gastrointestinal tract, from ingestion to excretion, was shorter with the Study regimen while mean colonic transit times were similar for both study groups.A CCE bowel preparation regimen using oral sulfate solution and diatrizoate solution as a boost agent is effective, safe, and achieved superior CCE completion.

Project description:Colorectal cancer is a leading cause of mortality and morbidity in Ontario. Most cases of colorectal cancer are preventable through early diagnosis and the removal of precancerous polyps. Colon capsule endoscopy is a non-invasive test for detecting colorectal polyps.The objectives of this analysis were to evaluate the cost-effectiveness and the impact on the Ontario health budget of implementing colon capsule endoscopy for detecting advanced colorectal polyps among adult patients who have been referred for computed tomographic (CT) colonography.We performed an original cost-effectiveness analysis to assess the additional cost of CT colonography and colon capsule endoscopy resulting from misdiagnoses. We generated diagnostic accuracy data from a clinical evidence-based analysis (reported separately), and we developed a deterministic Markov model to estimate the additional long-term costs and life-years lost due to false-negative results. We then also performed a budget impact analysis using data from Ontario administrative sources. One-year costs were estimated for CT colonography and colon capsule endoscopy (replacing all CT colonography procedures, and replacing only those CT colonography procedures in patients with an incomplete colonoscopy within the previous year). We conducted this analysis from the payer perspective.Using the point estimates of diagnostic accuracy from the head-to-head study between colon capsule endoscopy and CT colonography, we found the additional cost of false-positive results for colon capsule endoscopy to be $0.41 per patient, while additional false-negatives for the CT colonography arm generated an added cost of $116 per patient, with 0.0096 life-years lost per patient due to cancer. This results in an additional cost of $26,750 per life-year gained for colon capsule endoscopy compared with CT colonography. The total 1-year cost to replace all CT colonography procedures with colon capsule endoscopy in Ontario is about $2.72 million; replacing only those CT colonography procedures in patients with an incomplete colonoscopy in the previous year would cost about $740,600 in the first year.The difference in accuracy between colon capsule endoscopy and CT colonography was not statistically significant for the detection of advanced adenomas (? 10 mm in diameter), according to the head-to-head clinical study from which the diagnostic accuracy was taken. This leads to uncertainty in the economic analysis, with results highly sensitive to changes in diagnostic accuracy.The cost-effectiveness of colon capsule endoscopy for use in patients referred for CT colonography is $26,750 per life-year, assuming an increased sensitivity of colon capsule endoscopy. Replacement of CT colonography with colon capsule endoscopy is associated with moderate costs to the health care system.

Project description:BackgroundPatients with Crohn's disease (CD) undergo frequent endoscopic procedures, with visualization of the gastrointestinal mucosa central to treatment decision-making. Subsequently, a noninvasive alternative to optical colonoscopy (OC) would be welcomed. One such technology is capsule endoscopy, including the PillCam COLON 2 (PCC2), though research validating its use in ileocolonic CD is limited. This study aims to compare PCC2 with ileocolonoscopy (OC) in assessing mucosal CD through use of a standardized scoring system.MethodsAt an Australian tertiary hospital, same-day PCC2 and ileocolonoscopy results of 47 CD patients, with known nonstricturing disease, were prospectively collected and analyzed for correlation and agreement. Deidentified recordings were reported by a single expert gastroenterologist. Mucosal disease was quantified using the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD results of paired endoscopic modalities were compared in total per bowel segment and per SES-CD variable.ResultsOf 47 PCC2 recordings, 68% were complete, fully assessing terminal ileum to rectum, and OC was complete in 89%. Correlation (r) between total SES-CD scores was strongest in the terminal ileum (r = 0.77, P < .001), with the SES-CD variable of "ulcer detection" showing the strongest agreement. The PCC2 (vs OC) identified additional ulcers in the terminal ileum; ascending, transverse, and descending colon; and rectum; scores were 5 (1), 5 (3), 1 (1), 2 (1), and 2 (2), respectively.ConclusionsThe PCC2 shows promise in assessing ileocolonic mucosa, especially in proximal bowel segments, with greater reach of visualization in the small bowel. Given the resource and safety considerations raised by the Coronavirus disease 2019 pandemic, capsule endoscopy has particular significance.This article aims to contribute to the limited body of research surrounding the validity of capsule endoscopy technology in assessing ileocolonic mucosa in Crohn's Disease patients. In doing so, an alternative option for patients enduring frequent endoscopies is given potential.

Dataset Information

Booster medication to achieve capsule excretion in colon capsule endoscopy: a randomized controlled trial of three regimens.

Publications

Booster medication to achieve capsule excretion in colon capsule endoscopy: a randomized controlled trial of three regimens.

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