Optimization of the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure
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ABSTRACT:
DISEASE(S): Colorectal Neoplasms,Colorectal Cancer Screening
PROVIDER: 2192859 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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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:Introduction:
Prevention of colorectal cancer (CRC) is feasible through polypectomy on screening colonoscopy. Patient acceptance remains the main limiting factor for execution. Colon capsule endoscopy (CCE) might be a novel method for large populations.
Aims and methods:
Patients referred for screening means or lower gastrointestinal complaints were included in this single center pilot study. They underwent preparation and then ingested the capsule (PillCam Colon). Standard colonoscopy was performed the next morning. Significance was defined as polyps >5mm in size. Performance of exams was by independent physician with blinding of results.
| 2079066 | ecrin-mdr-crc
Project description:Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps >9 mm and polyps >5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete.
Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.
| 2333052 | ecrin-mdr-crc
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.
| S-EPMC5752722 | biostudies-literature
Project description:Goals: To explore factors associated with inadequate gastric preparation for MCE. Background: Factors associated with inadequate gastric preparation for magnetically controlled capsule endoscopy (MCE) remains unclear. Study: Data of patients who underwent MCE from June 2021 to July 2022 were prospectively collected. The gastric cleanliness score (GCS) of the six stomach regions (gastric cardia, fundus, body, angulus, antrum, and pylorus) was recorded. Patients with GCS score ≥18 were defined as the adequate preparation. Factors related to inadequate gastric preparation were analyzed using a logistic regression model with estimated odds ratios (OR). Results: The mean GCS score of 211 patients was 17.01 ± 2.82. In the multivariable analysis, proton pump inhibitor (PPI) use (OR 3.57; 95% CI 1.69-7.95; p < 0.01) and premedication time after administering simethicone <30 min (OR 2.86; 95% CI 1.10-7.39; p = 0.03) were independent risk factors for inadequate gastric preparation. Comparing the gastric cleanliness of different locations, the median GCS of the lower stomach [10.00, IQR (9.50, 11.00)] was significantly higher than that of the upper stomach [7.00, IQR (6.00, 8.00)] (p <0.001). Conclusion: PPI use and inadequate premedication time (<30 min) may reduce the quality of gastric preparation for MCE. The type, dose, duration of medication, and discontinuation time of PPIs was well worth further exploration. Appropriate control of the type and time of premedication may be the key to improving overall gastric cleanliness.
| S-EPMC10493275 | biostudies-literature
Project description:Interventions: Colon Capsule Endoscopy
Primary outcome(s): To evaluate the applicability of CCE in colorectal cancer screening in terms of: diagnostic yield, participation rate, patients’ expected and perceived burden of CCE, the workability of CCE for the staff and the interobserver variability in reviewing the CCE images.
Interested patients who meet all inclusion- and exclusion criteria will get an appointment to undergo Colon Capsule Endoscopy. Patients expected and perceived burden of CCE will be measured by 2 questionnaires, one prior to the procedure and one afterwards. The workability for the staff will be measured by a questionnaire which will be handed out to all staff working with CCE within this trial.
Study Design: N/A: single arm study, Open (masking not used), N/A , unknown, Other
| 2443282 | ecrin-mdr-crc
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: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: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