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"Colonoscopy - adverse effects"
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Effect of Colonoscopy Screening on Risks of Colorectal Cancer and Related Death
by
Adami, Hans-Olov
,
Hoff, Geir
,
Emilsson, Louise
in
Cancer
,
Clinical Medicine
,
Clinical Medicine General
2022
In this randomized trial involving 84,585 participants in Poland, Norway, and Sweden, the risk of colorectal cancer at 10 years was lower among those invited to undergo screening colonoscopy than among those assigned to no screening.
Journal Article
A comparison of the resection rate for cold and hot snare polypectomy for 4–9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study)
by
Yamauchi, Atsushi
,
Kawamura, Takuji
,
Takeuchi, Yoji
in
Adenomatous Polyps - surgery
,
Adult
,
Aged
2018
ObjectiveTo investigate the success rate of cold snare polypectomy (CSP) for complete resection of 4–9 mm colorectal adenomatous polyps compared with that of hot snare polypectomy (HSP).DesignA prospective, multicentre, randomised controlled, parallel, non-inferiority trial conducted in 12 Japanese endoscopy units. Endoscopically diagnosed sessile adenomatous polyps, 4–9 mm in size, were randomly assigned to the CSP or HSP group. After complete removal of the polyp using the allocated technique, biopsy specimens from the resection margin after polypectomy were obtained. The primary endpoint was the complete resection rate, defined as no evidence of adenomatous tissue in the biopsied specimens, among all pathologically confirmed adenomatous polyps.ResultsA total of 796 eligible polyps were detected in 538 of 912 patients screened for eligibility between September 2015 and August 2016. The complete resection rate for CSP was 98.2% compared with 97.4% for HSP. The non-inferiority of CSP for complete resection compared with HSP was confirmed by the +0.8% (90% CI −1.0 to 2.7) complete resection rate (non-inferiority p<0.0001). Postoperative bleeding requiring endoscopic haemostasis occurred only in the HSP group (0.5%, 2 of 402 polyps).ConclusionsThe complete resection rate for CSP is not inferior to that for HSP. CSP can be one of the standard techniques for 4–9 mm colorectal polyps. (Study registration: UMIN000018328)
Journal Article
The efficacy and safety of ciprofol and propofol in patients undergoing colonoscopy: A double-blind, randomized, controlled trial
2024
Propofol is a commonly utilized anesthetic for painless colonoscopy, but its usage is occasionally limited due to its potential side effects, including cardiopulmonary suppression and injection pain. To address this limitation, the novel compound ciprofol has been proposed as a possible alternative for propofol. This study sought to determine whether there are any differences in the safety and efficacy of propofol and ciprofol for painless colonoscopy.
Randomized clinical trial.
Single-centre, class A tertiary hospital, November 2021 to November 2022.
Adult, American Society of Anesthesiologists Physical Status I to II and body mass index of 18 to 30 kg m−2 patients scheduled to undergo colonoscopy.
Consecutive patients were randomly allocated in a 1:1 ratio to receive sedation for colonoscopy with ciprofol (group C) or propofol (group P).
The primary outcome was the success rate of colonoscopy. The secondary outcomes were onset time of sedation, operation time, recovery time and discharge time, patients and endoscopists satisfaction, side effects (e.g. injection pain, myoclonus, drowsiness, dizziness, procedure recall, nausea and vomiting) and incidence rate of cardiopulmonary adverse events.
No significant difference was found in the success rate of colonoscopy between the two groups (ciprofol 96.3% vs. propofol 97.6%; mean difference − 1.2%, 95% CI: −6.5% to 4.0%, P = 0.650). However, group C showed prolonged sedation (63.4 vs. 54.8 s, P < 0.001) and fully alert times (9 vs 8 min, P = 0.013), as well as reduced incidences of injection pain (0 vs. 40.2%, P < 0.001), respiratory depression (2.4% vs. 13.4%, P = 0.021) and hypotension (65.9% vs. 80.5%, P = 0.034). Patients satisfaction was also higher in Group C (10 vs 9, P < 0.001).
Ciprofol can be used independently for colonoscopy. When comparing the sedation efficacy of ciprofol and propofol, a 0.4 mg kg−1 dose of ciprofol proved to be equal to a 2.0 mg kg−1 dose of propofol, with fewer side effects and greater patient satisfaction during the procedure.
•Compared to the combination of ciprofol and opioids, ciprofol alone can still achieve a high success rates of colonoscopy.•Both are similar in efficacy, but ciprofol has a higher safety profile that making it more suitable for colonoscopy.•Less side effects and higher patient satisfaction of ciprofol compared with propofol.
Journal Article
Cold snare endoscopic resection for large colon polyps: a randomised trial
2025
BackgroundComplications of endoscopic mucosal resection (EMR) of large colorectal polyps remain a concern.ObjectiveWe aimed to compare safety and efficacy of cold EMR (without electrocautery) to hot EMR (with electrocautery) of large colorectal polyps.DesignIn this multicentre randomised trial, patients with any large (≥20 mm) non-pedunculated colon polyp were assigned to cold or hot EMR (primary intervention), and to submucosal injection with a viscous or non-viscous solution (secondary intervention) following a 2×2 design. The primary outcome was the rate of severe adverse events (SAEs). The secondary outcome was polyp recurrence. In this study, we report results of the primary intervention.Results660 patients were randomised and analysed. An SAE was observed in 2.1% of patients in the cold EMR group and in 4.3% in the hot EMR group (p=0.10) (per protocol analysis 1.4 vs 5.0%, p=0.017) with fewer perforations following cold EMR (0%) compared with hot EMR (1.6%, p=0.028). Postprocedure bleeding did not differ (1.5% vs 2.2%, p=0.57). The effect of cold resection was independent of the type of submucosal injection solution, polyp size or antithrombotic medications. Recurrence was detected in 27.6% and 13.6% in the cold and hot EMR groups, respectively (p<0.001). Recurrence was not significantly different for 20–29 mm polyps (18.6% vs 13.4%, p=0.24) and for sessile serrated polyps (14.1% vs 8.5%, p=0.33).ConclusionUniversal application of cold EMR did not significantly lower SAEs (unless cold EMR could be completed) and doubled the recurrence rate compared with hot EMR.Trial registration detailsClinicalTrials.gov, number: NCT03865537.
Journal Article
Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial
2017
Adenoma detection rate (ADR) is a key colonoscopy quality indicator in Western clinical literature. Our low ADR prompted us to assess novel methods to improve performance. Western retrospective reports suggested that water exchange (WE) could increase ADR. However, most of these studies used pain score or intubation rate as the primary outcome. Here we test the hypothesis that WE significantly increases ADR among Chinese colonoscopists and design a prospective randomized controlled trial using ADR as our primary outcome.
This prospective, randomized controlled trial was performed at six centers in China. Screening, surveillance, and diagnostic cases were randomized to be examined by WE or traditional air insufflation (AI) method. The primary outcome was ADR.
From April 2014 to July 2015, 3,303 patients were randomized to WE (n=1,653) and AI (n=1,650). The baseline characteristics were comparable. Overall ADR was 18.3% (WE) and 13.4% (AI) (relative risk 1.45, 95% confidential interval: 1.20-1.75, P<0.001). ADR in screening patients using AI was 25.8% (male) and 15.7% (female). ADR in screening patients aged >50 years old was 29.4% (WE) and 22.9% (AI) (relative risk 1.09, 95% confidential interval: 1.00-1.19, P=0.040). The increase by WE was reproducibly observed in all indication categories, and significant in screening and diagnostic cases. The limitation imposed by the unblinded investigators was mitigated by comparable inspection times in cases without polyps, similar adenoma per positive colonoscopy, and reproducible enhancement of ADR and adenoma per colonoscopy by WE across all eight investigators.
This prospective study confirms Western retrospective data that WE significantly improves ADR among Chinese colonoscopists. WE may be superior to AI for screening colonoscopy in China. Colonoscopists elsewhere with low ADR might consider evaluating WE for performance improvement.
Journal Article
Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial
by
Stokkers, PCF
,
Bossuyt, PMM
,
van der Vlugt, M
in
Academic Medical Centers - statistics & numerical data
,
Adenoma - diagnosis
,
Aged
2017
Background and aimsColonoscopy is the current reference standard for the detection of colorectal neoplasia, but nevertheless adenomas remain undetected. The Endocuff, an endoscopic cap with plastic projections, may improve colonic visualisation and adenoma detection. The aim of this study was to compare the mean number of adenomas per patient (MAP) and the adenoma detection rate (ADR) between Endocuff-assisted colonoscopy (EAC) and conventional colonoscopy (CC).MethodsWe performed a multicentre, randomised controlled trial in five hospitals and included fecal immonochemical test (FIT)-positive screening participants as well as symptomatic patients (>45 years). Consenting patients were randomised 1:1 to EAC or CC. All colonoscopies were performed by experienced colonoscopists (≥500 colonoscopies) who were trained in EAC. All colonoscopy quality indicators were prospectively recorded.FindingsOf the 1063 included patients (52% male, median age 65 years), 530 were allocated to EAC and 533 to CC. More adenomas were detected with EAC, 722 vs 621, but the gain in MAP was not significant: on average 1.36 per patient in the EAC group versus 1.17 in the CC group (p=0.08). In a per-protocol analysis, the gain was 1.44 vs 1.19 (p=0.02), respectively. In the EAC group, 275 patients (52%) had one or more adenomas detected versus 278 in the CC group (52%; p=0.92). For advanced adenomas these numbers were 109 (21%) vs 117 (22%). The adjusted caecal intubation rate was lower with EAC (94% vs 99%; p<0.001), however when allowing crossover from EAC to CC, they were similar in both groups (98% vs 99%; p value=0.25).InterpretationThough more adenomas are detected with EAC, the routine use of Endocuff does not translate in a higher number of patients with one or more adenomas detected. Whether increased detection ultimately results in a lower rate of interval carcinomas is not yet known.Trial registration numberhttp://www.trialregister.nl Dutch Trial Register: NTR3962.
Journal Article
Participation and yield of colonoscopy versus non-cathartic CT colonography in population-based screening for colorectal cancer: a randomised controlled trial
by
van de Vijver, Marc J
,
Stoker, Jaap
,
Biermann, Katharina
in
Adenoma - diagnosis
,
Adenoma - diagnostic imaging
,
Adenoma - pathology
2012
Screening for colorectal cancer is widely recommended, but the preferred strategy remains unidentified. We aimed to compare participation and diagnostic yield between screening with colonoscopy and with non-cathartic CT colonography.
Members of the general population, aged 50–75 years, and living in the regions of Amsterdam or Rotterdam, identified via the registries of the regional municipal administration, were randomly allocated (2:1) to be invited for primary screening for colorectal cancer by colonoscopy or by CT colonography. Randomisation was done per household with a minimisation algorithm based on age, sex, and socioeconomic status. Invitations were sent between June 8, 2009, and Aug 16, 2010. Participants assigned to CT colonography who were found to have one or more large lesions (≥10 mm) were offered colonoscopy; those with 6–9 mm lesions were offered surveillance CT colonography. The primary outcome was the participation rate, defined as number of invitees undergoing the examination relative to the total number of invitees. Diagnostic yield was calculated as number of participants with advanced neoplasia relative to the total number of invitees. Invitees and screening centre employees were not masked to allocation. This trial is registered in the Dutch trial register, number NTR1829.
1276 (22%) of 5924 colonoscopy invitees participated, compared with 982 (34%) of 2920 CT colonography invitees (relative risk [RR] 1·56, 95% CI 1·46–1·68; p<0·0001). Of the participants in the colonoscopy group, 111 (9%) had advanced neoplasia of whom seven (<1%) had a carcinoma. Of CT colonography participants, 84 (9%) were offered colonoscopy, of whom 60 (6%) had advanced neoplasia of whom five (<1%) had a carcinoma; 82 (8%) were offered surveillance. The diagnostic yield for all advanced neoplasia was 8·7 per 100 participants for colonoscopy versus 6·1 per 100 for CT colonography (RR 1·46, 95% CI 1·06–2·03; p=0·02) and 1·9 per 100 invitees for colonoscopy and 2·1 per 100 invitees for CT colonography (RR 0·91, 0·66–2·03; p=0·56). The diagnostic yield for advanced neoplasia of 10 mm or more was 1·5 per 100 invitees for colonoscopy and 2·0 per 100 invitees for CT colonography, respectively (RR 0·74, 95% CI 0·53–1·03; p=0·07). Serious adverse events related to the screening procedure were post-polypectomy bleedings: two in the colonoscopy group and three in the CT colonography group.
Participation in colorectal cancer screening with CT colonography was significantly better than with colonoscopy, but colonoscopy identified significantly more advanced neoplasia per 100 participants than did CT colonography. The diagnostic yield for advanced neoplasia per 100 invitees was similar for both strategies, indicating that both techniques can be used for population-based screening for colorectal cancer. Other factors such as cost-effectiveness and perceived burden should be taken into account when deciding which technique is preferable.
Netherlands Organisation for Health Research and Development, Centre for Translational Molecular Medicine, and the Nuts Ohra Foundation.
Journal Article
Capnographic Monitoring in Routine EGD and Colonoscopy With Moderate Sedation: A Prospective, Randomized, Controlled Trial
by
Kirsh, Brian
,
Kochhar, Gursimran
,
Wang, Yinghong
in
Adult
,
Aged
,
Analgesics, Opioid - administration & dosage
2016
Regulatory changes requiring the use of capnographic monitoring for endoscopic procedures using moderate sedation have placed financial challenges on ambulatory and hospital endoscopy centers across the United States due to the increased cost of training endoscopy personnel and purchasing both capnography-monitoring devices and specialized sampling ports. To date, there has been no published data supporting the use of capnographic monitoring in adult patients undergoing routine endoscopic procedures with moderate sedation. The aim of this randomized, parallel group assignment trial was to determine whether intervention based on capnographic monitoring improves detection of hypoxemia in patients undergoing routine esophagogastroduodenoscopy (EGD) or colonoscopy with moderate sedation.
Healthy patients (ASA Physical Classification (ASAPS) I and II)) scheduled for routine outpatient EGD or colonoscopy under moderate sedation utilizing opioid and benzodiazepine combinations were randomly assigned to a blinded capnography alarm or open capnography alarm group. In both study arms, standard cardiopulmonary monitoring devices were utilized with additional capnographic monitoring. The primary end point was the incidence of hypoxemia defined as a fall in oxygen saturation (SaO2) to <90% for ≥10 s. Secondary outcomes included severe hypoxemia, apnea, disordered respirations, hypotension, bradycardia, and early procedure termination for any cause.
A total of 452 patients were randomized; 218 in the EGD and 234 in the colonoscopy groups; 75 subjects in the EGD group (35.9%) and 114 patients (49.4%) in the colonoscopy group were male, and average body mass index was 27.9 and 29.1 (kg/m(2)), respectively. The blinded and open alarm groups in each study arm were similar in regards to use of opioids and/or benzodiazepines and ASAPS classification. There was no significant difference in rates of hypoxemia between the blinded and open capnography arms for EGD (54.1% vs. 49.5; P=0.5) or colonoscopy (53.8 vs. 52.1%; P=0.79).
Capnographic monitoring in routine EGD or colonoscopy for ASAPS I and II patients does not reduce the incidence of hypoxemia (ClinicalTrials.gov number, NCT01994785).
Journal Article
A Patient-Blinded Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion, and Water Exchange During Minimally Sedated Colonoscopy
2014
Minimal sedation obviates patient recovery burdens, but intolerable pain limits success of cecal intubation. Painless or minimally uncomfortable insertion ensures success of cecal intubation, current patient satisfaction, and willingness to repeat future colonoscopy with minimal sedation. Water immersion (WI) and water exchange (WE), when separately compared with air insufflation (AI), significantly reduced insertion pain. To assess comparative effectiveness, we conducted a randomized controlled trial with head-to-head comparison of these three methods. We hypothesized that WE could produce the highest proportion of patients reporting painless insertion.
This prospective patient-blinded trial (NCT01535326) enrolled minimally sedated (25 mg intramuscular meperidine) patients randomized to AI, WI, or WE (90 patients/group) to aid insertion. The previously validated primary outcome was the proportion of patients reporting painless insertion.
Painless insertion was reported by 30.0% (AI), 43.3% (WI), and 61.1% (WE) of patients (P<0.001). Multivariate logistic regression analysis revealed that, after adjusting for gender, body mass index, abdominal compression, position change, insertion time to cecum, and length of scope at cecum, only WE was significantly associated with painless insertion compared with AI (odds ratio (OR)=0.08, 95% confidence interval (CI)=0.03-0.24, P<0.001) or WI (OR=0.14, 95% CI=0.05-0.40, P<0.001). Adenoma detection rate (ADR) in the right (cecum and ascending) colon was 11.1% (AI), 14.4% (WI), and 26.7% (WE) (P=0.015). The limitations included single site study with unblinded colonoscopist and assistant.
This head-to-head comparison of AI vs. WI vs. WE confirmed that WE was superior to WI and AI, with a significantly greater proportion of patients reporting painless insertion. The significantly higher ADR in the right colon in the WE group warrants further investigations.
Journal Article
Transrectal Drainage Tube Use for Preventing Postendoscopic Submucosal Dissection Coagulation Syndrome in Patients With Colorectal Lesions: A Multicenter Randomized Controlled Clinical Trial
2025
INTRODUCTION:Postendoscopic submucosal dissection (ESD) coagulation syndrome (PECS) prevention is one of the common postoperative complications of colorectal ESD. Considering the increasing incidence of PECS, it is critical to investigate various prevention methods. The objective of this study was to evaluate the efficacy of transrectal drainage tubes (TDTs) in PECS prevention in patients following colorectal ESD.METHODS:From July 2022 to July 2023, a multicenter, randomized controlled clinical trial was conducted in 3 hospitals in China. Patients with superficial colorectal lesions ≥20 mm who had undergone ESD for a single lesion were enrolled. Initially, 229 patients were included in the study and 5 were excluded. Two hundred twenty-four were randomly assigned to the TDT and non-TDT group in the end. This open-label study utilized a parallel design with a 1:1 allocation ratio, and endoscopists and patients were not blind to the randomization, and a 24 Fr drainage tube was inserted approximately 10-15 cm above the anus after the ESD under the endoscopy and tightly attached to a drainage bag. The TDTs were removed in 1-3 days following the ESD.RESULTS:A total of 229 eligible patients were enrolled in this study, and 5 patients were excluded. Ultimately, 224 patients were assigned to the TDT group (n = 112) and non-TDT group (n = 112). The median age for the patients was 63.45 years (IQR 57-71; 59 men [52.68%]) in the TDT group and 60.95 years (IQR 54-68; 60 men [53.57%]) in the non-TDT group. Intention-to-treat analysis showed patients in the TDT group had a lower incidence of PECS than patients in the non-TDT group (7 [6.25%] vs 20 [17.86%]; relative risk, 0.350; 95% confidence interval [CI], 0.154-0.795; P = 0.008). In the subgroup analysis, TDTs were found to prevent PECS in patients of the female gender (odd ratio, 0.097; 95% CI, 0.021-0.449; P = 0.001), tumor size <4 cm (odd ratio, 0.203; 95% CI, 0.056-0.728; P = 0.011), tumor located in the left-sided colorectum (odd ratio, 0. 339 95% CI, 0.120-0.957; P = 0.035), and shorter procedure time (<45 minutes) (odd ratio, 0.316; 95% CI, 0.113-0.879; P = 0.023). The tube fell off in 1 case (0.89%) accidentally ahead of time. No TDT-related complication was observed.DISCUSSION:The results from this randomized clinical study indicate that the application of TDTs effectively reduced the incidence of PECS in patients after colorectal ESD (chictr.org.cn Identifier: ChiCTR2200062164).
Journal Article