Bowel preparation for colon capsule endoscopy examination
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ABSTRACT:
DISEASE(S): Colorectal Tumor
PROVIDER: 2633895 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:AimTo assess the cleansing efficacy and safety of a new Colon capsule endoscopy (CCE) bowel preparation regimen.MethodsThis 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.ResultsBoth 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.ConclusionA CCE bowel preparation regimen using oral sulfate solution and diatrizoate solution as a boost agent is effective, safe, and achieved superior CCE completion.
| S-EPMC5752722 | biostudies-literature
Project description:The study aims to investigate the effect of the optimized bowel preparation and boost regimens on colon capsule endoscopy procedures, specifically on cleanliness and completion rate.
| 8188 | ecrin-mdr-crc
Project description:Background and study aimsColon capsule endoscopy (CCE) is becoming increasingly popular in Europe. However, development of quality assurance and standardized terminology has not kept pace with clinical integration of this technology. As a result, there are significant variations in reporting standards, highlighting the need for a standardized terminology and framework. We used the RAND process to achieve a consensus of experts to determine the terminology in CCE, bowel cleansing assessment, and quality assurance reporting and future research priorities.MethodsA panel comprising 14 European CCE experts evaluated 45 statements during the international REFLECT symposium (Nyborg, Denmark) through three survey rounds and face-to-face and virtual discussions in the initial two rounds. Participants anonymously rated statement appropriateness.ResultsTwenty-eight consensus statements were developed. Eight statements focus on consistent terminology for confirming CCE-detected polypoid and inflammatory colonic lesions with colonoscopy. To ensure standardization and quality assurance, 13 mandatory fields were recommended for inclusion in a CCE report. Three endorsed reporting methodologies were suggested, emphasizing prompt notification for suspected malignant findings, recommending a generic disclaimer regarding stomach and small bowel visualization intentions, and establishing reporting timelines at an interdepartmental level based on urgency. Four bowel preparation scale-related statements led to the recommendation to adoptithe Colon Capsule CLEansing Assessment and Reporting (CC-CLEAR) scale as the preferred scale.ConclusionsThis study established a framework for terminology, reporting, and assessment of bowel cleansing for CCE. Future research should focus on optimizing bowel preparation regimens and exploring artificial intelligence applications in CCE.
| S-EPMC11827750 | biostudies-literature
Project description:Background and study aims Colon capsule endoscopy (CCE) is an alternative to conventional colonoscopy (CC) in specific clinical settings. High completion rates (CRs) and adequate cleanliness rates (ACRs) are fundamental quality parameters if CCE is to be widely implemented as a CC equivalent diagnostic modality. We conducted a systematic review and meta-analysis to investigate the efficacy of different bowel preparations regimens on CR and ACR in CCE. Patients and methods We performed a systematic literature search in PubMed, Embase, CINAHL, Web of Science, and the Cochrane Library. Data were independently extracted per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The primary outcome measures (CR, ACR) were retrieved from the individual studies and pooled event rates were calculated. Results Thirty-four observational (OBS) studies (n = 3,789) and 12 randomized clinical trials (RCTs) (n = 1,214) comprising a total 5,003 patients were included. The overall CR was 0.798 (95 % CI, 0.764-0.828); the highest CRs were observed with sodium phosphate (NaP) + gastrografin booster (n = 2, CR = 0.931, 95 % CI, 0.820-0.976). The overall ACR was 0.768 (95 % CI, 0.735-0.797); the highest ACRs were observed with polyethylene glycol (PEG) + magnesium citrate (n = 4, ER = 0.953, 95 % CI, 0.896-0.979). Conclusions In the largest meta-analysis on CCE bowel preparation regimens, we found that both CRs and ACRs are suboptimal compared to the minimum recommended standards for CC. PEG laxative and NaP booster were the most commonly used but were not associated with higher CRs or ACRs. Well-designed studies on CCE should be performed to find the optimal preparation regimen.
| S-EPMC8589531 | biostudies-literature
Project description:This study is designed to determine the optimal bowel preparation regimen for PillCam COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients.
Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.
| 2192859 | ecrin-mdr-crc
Project description:Background and study aims Colon capsule endoscopy (CCE) has the potential to explore the entire gastrointestinal tract. The aim of this study was to assess the applicability of CCE as pan-endoscopy. Patients and methods Healthy participants received CCE with bowel preparation (bisacodyl, polyethylene electrolyte glycol (PEG) + ascorbic acid) and booster regimen (metoclopramide, oral sulfate solution (OSS)). For each segment of the gastrointestinal tract, the following quality parameters were assessed: cleanliness, transit times, reading times, patient acceptance and safety of the procedure. When all gastrointestinal segments had cleansing score good or excellent, cleanliness of the whole gastrointestinal tract was assessed as good. Participants' expected and perceived burden was assessed by questionnaires and participants were asked to grade the procedure (scale 0-10). All serious adverse events (SAEs) were documented. Results A total of 451 CCE procedures were analyzed. A good cleansing score was achieved in the stomach in 69.6%, in the SB in 99.1 % and in the colon in 76.6 %. Cleanliness of the whole gastrointestinal tract was good in 52.8 % of the participants. CCE median transit time of the whole gastrointestinal tract was 583 minutes IQR 303-659). The capsule reached the descending colon in 94.7 %. Median reading time per procedure was 70 minutes (IQR 57-83). Participants graded the procedure with a 7.8. There were no procedure-related SAEs. Conclusions CCE as pan-endoscopy has shown to be a safe procedure with good patient acceptance. When cleanliness of all gastrointestinal segments per patient, completion rate and reading time will be improved, CCE can be applied as a good non-invasive alternative to evaluate the gastrointestinal tract.
| S-EPMC8670994 | biostudies-literature
Project description:BackgroundCapsule endoscopy (CE) is frequently hindered by intra-luminal debris. Our aim was to determine whether a combination bowel preparation would improve small-bowel visualization, diagnostic yield, and the completion rate of CE.MethodsSingle-blind, prospective randomized-controlled study of outpatients scheduled for CE. Bowel-preparation subjects ingested 2 L of polyethylene glycol solution the night prior to CE, 5 mL simethicone and 5 mg metoclopramide 20 minutes prior to CE and laid in the right lateral position 30 minutes after swallowing CE. Controls had no solid food after 7 p.m. the night prior to CE and no liquids 4 hours prior to CE. Participants completed a satisfaction survey. Capsule readers completed a small-bowel-visualization assessment.ResultsFifty patients were prospectively enrolled (56% female) with a median age of 54.4 years and 44 completed the study (23 patients in the control group and 21 in the preparation group). There was no significant difference between groups on quartile-based small-bowel visualization (all P > 0.05). There was no significant difference between groups in diagnostic yield (P = 0.69), mean gastric (P = 0.10) or small-bowel transit time (P = 0.89). The small-bowel completion rate was significantly higher in the preparation group (100% vs 78%; P = 0.02). Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%; P = 0.01).ConclusionsCombined bowel preparation did not improve small-bowel visualization but did significantly increase patient discomfort. The CE completion rate improved in the preparation group but the diagnostic yield was unaffected. Based on our findings, a bowel preparation prior to CE does not appear to improve CE performance and results in decreased patient satisfaction (ClinicalTrials.gov, No. NCT01243736).
| S-EPMC7217271 | biostudies-literature
Project description:BackgroundCapsule endoscopy (CE) is useful for managing patients with suspected small bowel diseases. However, the effect of prolonged CE examination time on CE performance is unknown.AimTo evaluate the completeness and diagnostic yield of prolonged CE imaging in patients with suspected small bowel bleeding.MethodsWe reviewed consecutive records of adult CE examinations via an overnight protocol from Jan 2016 to Dec 2020 at a tertiary center in Taiwan. We subcategorized the CE records by recording length into within 8 h, within 12 h and throughout the whole procedure and compared the completion rate and diagnostic yield between the groups. Cochran's Q test was used for statistical analysis.ResultsA total of 88 patients were enrolled with 78.4% inpatients (median age 72 years). The small bowel evaluation completion rate was 93.2%, which was significantly greater than the 79.5% rate within 12 h (p = 0.025) and the 58% rate within 8 h (p < 0.001). The diagnostic yield was 83% in the whole-course overnight study, which was significantly greater than the 71.6% diagnostic yield within 8 h (p < 0.001) and similar to the 81.8% diagnostic yield within 12 h.ConclusionProlonged overnight CE examination can improve the completion rate and diagnostic yield and should be considered for routine clinical practice.
| S-EPMC11440704 | biostudies-literature
Project description:Bowel preparation regimens for colon capsule endoscopy are not yet standardized since they are not well optimized. The aim of the present study was to evaluate the feasibility of a novel low-volume and sodium phosphate-free bowel preparation regimen for colon capsule endoscopy. A total of 31 patients were prospectively enrolled. In the novel regimen, on the day prior to examination, a low-fiber diet was permitted, 5 mg mosapride citrate was administered twice (1 h prior to lunch and supper) and 1 l polyethylene glycol was administered in the evening. On the day of the examination, an additional 1 l polyethylene glycol, 5 mg mosapride citrate and 200 mg simethicone were administered before capsule ingestion. Polyethylene glycol booster (0.5 l) was administered twice, at 1 and 4 h following capsule ingestion. Colon cleansing levels, ileocecal valve transit time and completion rate were evaluated. A total of 29 patients were included in the final analysis, 90% of whom achieved adequate preparation of the overall colon. Ileocecal valve transit time was 2.35±0.82 h and completion rate was 79.3%. The results revealed that the novel low-volume and sodium phosphate-free bowel preparation regimen for colon capsule endoscopy was feasible, with adequate colon cleansing and completion rates, and has the potential to be used as an alternative regimen.
| S-EPMC5525907 | biostudies-other
Project description:BackgroundThe diagnostic accuracy of colon capsule endoscopy (CCE) depends on a well-cleansed bowel. Evaluating the cleansing quality can be difficult with a substantial interobserver variation.ObjectivesOur primary aim was to establish a standard of agreement for bowel cleansing in CCE based on evaluations by expert readers. Then, we aimed to investigate the interobserver agreement on bowel cleansing.DesignWe conducted an interobserver agreement study on bowel cleansing quality.MethodsReaders with different experience levels in CCE and colonoscopy evaluated bowel cleansing quality on the Leighton-Rex scale and Colon Capsule CLEansing Assessment and Report (CC-CLEAR), respectively. All evaluations were reported on an image level. A total of 24 readers rated 500 images on each scale.ResultsAn expert opinion-based agreement standard could be set for poor and excellent cleansing but not for the spectrum in between, as the experts agreed on only a limited number of images representing fair and good cleansing. The overall interobserver agreement on the Leighton-Rex full scale was good (intraclass correlation coefficient (ICC) 0.84, 95% CI (0.82-0.85)) and remained good when stratified by experience level. On the full CC-CLEAR scale, the overall agreement was moderate (ICC 0.62, 95% CI (0.59-0.65)) and remained so when stratified by experience level.ConclusionThe interobserver agreement was good for the Leighton-Rex scale and moderate for CC-CLEAR, irrespective of the reader's experience level. It was not possible to establish an expert-opinion standard of agreement for cleansing quality in CCE images. Dedicated training in using the scales may improve agreement and enable future algorithm calibration for artificial intelligence supported cleansing evaluation.Trial registrationAll included images were derived from the CAREforCOLON 2015 trial (Registered with The Regional Health Research Ethics Committee (Registration number: S-20190100), the Danish data protection agency (Ref. 19/29858), and ClinicalTrials.gov (registration number: NCT04049357)).
| S-EPMC11500223 | biostudies-literature