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A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:The clinical benefit of early colonoscopy within 24 h of arrival in patients with severe acute lower gastrointestinal bleeding (ALGIB) remains controversial. This trial will compare early colonoscopy (performed within 24 h) versus elective colonoscopy (performed between 24 and 96 h) to examine the identification rate of stigmata of recent hemorrhage (SRH) in ALGIB patients. We hypothesize that, compared with elective colonoscopy, early colonoscopy increases the identification of SRH and subsequently improves clinical outcomes. METHODS:This trial is an investigator-initiated, multicenter, randomized, open-label, parallel-group trial examining the superiority of early colonoscopy over elective colonoscopy (standard therapy) in ALGIB patients. The primary outcome measure is the identification of SRH. Secondary outcomes include 30-day rebleeding, success of endoscopic treatment, need for additional endoscopic examination, need for interventional radiology, need for surgery, need for transfusion during hospitalization, length of stay, 30-day thrombotic events, 30-day mortality, preparation-related adverse events, and colonoscopy-related adverse events. The sample size will enable detection of a 9% SRH rate in elective colonoscopy patients and a SRH rate of ??26% in early colonoscopy patients with a risk of type I error of 5% and a power of 80%. DISCUSSION:This trial will provide high-quality data on the benefits and risks of early colonoscopy in ALGIB patients. TRIAL REGISTRATION:UMIN-CTR Identifier, UMIN000021129 . Registered on 21 February 2016; ClinicalTrials.gov Identifier, NCT03098173 . Registered on 24 March 2017.

SUBMITTER: Niikura R

PROVIDER: S-EPMC5883587 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial.

Niikura Ryota R Nagata Naoyoshi N Yamada Atsuo A Doyama Hisashi H Shiratori Yasutoshi Y Nishida Tsutomu T Kiyotoki Shu S Yada Tomoyuki T Fujita Tomoki T Sumiyoshi Tetsuya T Hasatani Kenkei K Mikami Tatsuya T Honda Tetsuro T Mabe Katsuhiro K Hara Kazuo K Yamamoto Katsumi K Takeda Mariko M Takata Munenori M Tanaka Mototsugu M Shinozaki Tomohiro T Fujishiro Mitsuhiro M Koike Kazuhiko K

Trials 20180403 1

<h4>Background</h4>The clinical benefit of early colonoscopy within 24 h of arrival in patients with severe acute lower gastrointestinal bleeding (ALGIB) remains controversial. This trial will compare early colonoscopy (performed within 24 h) versus elective colonoscopy (performed between 24 and 96 h) to examine the identification rate of stigmata of recent hemorrhage (SRH) in ALGIB patients. We hypothesize that, compared with elective colonoscopy, early colonoscopy increases the identification ...[more]

PMID: 29615078

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Project description:To compare magnetic imaging-assisted colonoscopy (MIC) with conventional colonoscopy (CC).Magnetic imaging technology provides a computer-generated image of the shape and position of the colonoscope onto a monitor to give visual guidance to the endoscopist. It is designed to improve colonoscopy performance and tolerability for patients by enabling visualization of loop formation and endoscope position. Recently, a new version of MIC technology was developed for which there are limited data.To evaluate this latest generation of MIC among experienced rather than inexperienced or trainee endoscopists, a prospective randomized trial was performed using only gastroenterologists with therapeutic endoscopy training. Consecutive patients undergoing elective outpatient colonoscopy were randomized to MIC or CC, with patients blinded to their group assignment. Endoscopic procedural metrics and quantities of conscious sedation medications were recorded during the procedures. The procedure was classified as "usual" or "difficult" by the endoscopist at the conclusion of each case based on the need for adjunctive maneuvers to facilitate endoscope advancement. After more than one hour post-procedure, patients completed a 10 cm visual analogue pain scale to reflect the degree of discomfort experienced during their colonoscopy. The primary outcome was patient comfort expressed by the visual analogue pain score. Secondary outcomes consisted of endoscopic procedural metrics as well as a sedation score derived from standardized dose increments of the conscious sedation medications.Two hundred fifty-three patients were randomized and underwent MIC or CC between September 2011 and October 2012. The groups were similar in terms of the indications for colonoscopy and patient characteristics. There were no differences in cecal intubation rates (100% vs 99%), insertion distance-to-cecum (82 cm vs 83 cm), time-to-cecum (6.5 min vs 7.2 min), or polyp detection rate (47% vs 52%) between the MIC and CC groups. The primary outcome of mean pain score (1.0 vs 0.9 out of 10, P = 0.41) did not differ between MIC and CC groups, nor did the mean sedation score (8.2 vs 8.5, P = 0.34). Within the subgroup of cases considered more challenging or difficult, time-to-cecum was significantly faster with MIC compared to CC, 10.1 min vs 13.4 min respectively (P = 0.01). Sensitivity analyses confirmed a similar pattern of overall findings when each endoscopist was considered separately, demonstrating that the mean results for the entire group were not unduly influenced by outlier results from any one endoscopist.Although the latest version of MIC resulted in faster times-to-cecum within a subgroup of more challenging cases, overall it was no better than CC in terms of patient comfort, sedation requirements and endoscopic procedural metrics, when performed in experienced hands.

Project description:AimTo study the significance of cap-fitted colonoscopy in improving cecal intubation time and polyp detection rate.MethodsThis study was a prospective randomized controlled trial conducted from March 2008 to February 2009 in a tertiary referral hospital at Sydney. The primary end point was cecal intubation time and the secondary endpoint was polyp detection rate. Consecutive cases of total colonoscopy over a 1-year period were recruited. Randomization into either standard colonoscopy (SC) or cap-assisted colonoscopy (CAC) was performed after consent was obtained. For cases randomized to CAC, one of the three sizes of cap was used: D-201-15004 (with a diameter of 15.3 mm), D-201-14304 (14.6 mm) and D-201-12704 (13.0 mm). All of these caps were produced by Olympus Medical Systems, Japan. Independent predictors for faster cecal time and better polyp detection rate were also determined from this study.ResultsThere were 200 cases in each group. There was no significant difference in terms of demographic characteristics between the two groups. CAC, when compared to the SC group, had no significant difference in terms of cecal intubation rate (96.0% vs 97.0%, P = 0.40) and time (9.94 +/- 7.05 min vs 10.34 +/- 6.82 min, P = 0.21), or polyp detection rate (32.8% vs 31.3%, P = 0.75). On the subgroup analysis, there was no significant difference in terms of cecal intubation time by trainees (88.1% vs 84.8%, P = 0.40), ileal intubation rate (82.5% vs 79.0%, P = 0.38) or total colonoscopy time (23.24 +/- 13.95 min vs 22.56 +/- 9.94 min, P = 0.88). On multivariate analysis, the independent determinants of faster cecal time were consultant-performed procedures (P < 0.001), male patients (P < 0.001), non-usage of hyoscine (P < 0.001) and better bowel preparation (P = 0.01). The determinants of better polyp detection rate were older age (P < 0.001), no history of previous abdominal surgery (P = 0.04), patients not having esophagogastroduodenoscopy in the same setting (P = 0.003), trainee-performed procedures (P = 0.01), usage of hyoscine (P = 0.01) and procedures performed for polyp follow-up (P = 0.01). The limitations of the study were that it was a single-center experience, no blinding was possible, and there were a large number of endoscopists.ConclusionCAC did not significantly different from SC in term of cecal intubation time and polyp detection rate.

Project description:BackgroundThe number of elective outpatient surgeries in Canada has increased markedly in the last 10 years. However, unanticipated cancellations on the day of surgery and adverse postoperative events are frequent. Modern technologies have been shown to be of great help in the medical field in improving patient care. Thus, it is likely that dedicated technologies could also significantly improve surgical outpatients' pathways. Therefore, the department of anesthesiology at the University of Montreal Medical Center, in collaboration with LeoMed, a telemedicine platform, has developed a telehealth solution to offer more efficient perioperative support and follow-up for patients undergoing ambulatory surgery.ObjectiveThe objective is to evaluate the medicoeconomic benefit of a dedicated perioperative telehealth platform for patients undergoing day surgery. Our hypothesis is that this dedicated telecare solution will allow more efficient patient care, which will reduce all types of medical costs related to day surgery pathways.MethodsThis study is a single-center, single-blinded, 2-group randomized controlled trial. One thousand patients aged over 18 years with internet access who are scheduled to undergo ambulatory surgery will be enrolled and randomized either to follow a perioperative path that includes a patient-tailored perioperative digital app via the LeoMed telecare platform for 1 month or to follow the standard of care, which does not offer personalized digital support. The primary outcome will be to evaluate the cost-effectiveness of the telecare platform, assessing direct costs from factors such as unanticipated cancellations on the day of surgery due to preoperative instructions not being followed, calls to the local health information line, calls to the provincial health information line, emergency department consultations, unplanned readmissions, or medical visits for problems related to the surgical procedure within the first 30 days after the intervention. The secondary outcome will be to evaluate cost utility using a questionnaire assessing quality-adjusted life years. A blinded independent research team will analyze outcomes. All data will be analyzed according to the intention-to-treat principle. A sample size of 500 subjects in each group was calculated to detect a 21% reduction in postoperative complications with a power of 90%. This study has been approved by the ethics board of Centre hospitalier de l'Université de Montréal (University of Montreal Health Centre). No employee of LeoMed was involved in the study conception, and none will be involved in either data collection or analysis.ResultsResults of this trial will be useful to determine the economic benefit of a telecare platform specifically developed for surgical outpatient pathways.ConclusionsWe believe that the deployment of a dedicated perioperative telehealth app will lead to better patient care and fewer postoperative complications, which will lower all types of costs related to surgical outpatient care.Trial registrationClinicalTrials.gov NCT04948632; https://ClinicalTrials.gov/ct2/show/NCT04948632.International registered report identifier (irrid)DERR1-10.2196/44006.

Project description:BackgroundThere are limited data on the safety of colonoscopy in patients with lower gastrointestinal bleeding (LGIB). We examined the various adverse events associated with colonoscopy in acute LGIB compared with non-GIB patients.MethodsEmergency hospitalized LGIB patients (n = 161) and age- and gender-matched non-GIB controls (n = 161) were selected. Primary outcomes were any adverse events during preparation and colonoscopy procedure. Secondary outcomes were five bowel preparation-related adverse events--hypotension, systolic blood pressure <100 mmHg, volume overload, vomiting, aspiration pneumonia and loss of consciousness--and four colonoscopy-related adverse events--including hypotension, perforation, cerebrocardiovascular events and sepsis.ResultsDuring bowel preparation, 16 (9%) LGIB patients experienced an adverse event. None of the LGIB patients experienced volume overload, aspiration pneumonia or loss of consciousness; however, 12 (7%) had hypotension and 4 (2%) vomited. There were no significant differences in the five bowel preparation-related adverse events between LGIB and non-GIB patients. During colonoscopy, 25 (15%) LGIB patients experienced an adverse event. None LGIB patient had perforation or sepsis; however, 23 (14%) had hypotension and 2 (1%) experienced a cerebrocardiovascular event. There was no significant difference in the four colonoscopy-related adverse events between LGIB and non-GIB patients. In addition, no significant difference in any of the nine adverse events was found among subgroups: patients aged ≥65 years, those with comorbidities, and those with antithrombotic drug use.ConclusionsAdverse events in bowel preparation and colonoscopy among acute LGIB patients were low. No significant difference was found in adverse events between LGIB and non-GIB patients. These adverse events were also low in elderly LGIB patients, as well as in those with co-morbidities and antithrombotic drug use, suggesting that colonoscopy performed during acute LGIB did not increase adverse events.

Project description:BackgroundGlobal research on endoscopic therapies in combination with partial splenic embolization (PSE) for variceal hemorrhage (VH) is limited. Therefore, we aimed to evaluate the efficacy and safety of endoscopy plus PSE (EP) treatment in comparison to endoscopic (E) treatment for the secondary prophylaxis of VH in cirrhosis patients with hypersplenism.MethodsCirrhosis patients with hypersplenism (platelet count < 100, 000/µL) and those who had recovered from an episode of VH were enrolled in a multicenter randomized controlled trial. The participants were randomly assigned into EP and E groups in a 1:1 ratio. The primary endpoint was variceal rebleeding, and the secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up. Hematological indices, serum biochemical parameters, and the Child-Pugh score were measured at each time point.ResultsFrom June 2016 to December 2019, 108 patients were enrolled in the study, among which 102 patients completed the protocol (51 in EP and 51 in E group). The rebleeding rate of the varices was significantly reduced in the EP group compared to that in the E group during the 2 years (16% vs. 31%, p < 0.001). The EP group showed a significantly lower variceal recurrence rate than the E group (22% vs. 67%, p < 0.001). The COX proportional hazard models revealed that grouping was an independent predictor for variceal rebleeding (H = 0.122, 95% CI 0.055-0.270, p < 0.001) and variceal recurrence (hazard ratio, H = 0.160, 95% CI 0.077-0.332, p < 0.001). The peripheral blood cell count, Child-Pugh class/score, albumin concentration, and coagulation function in the EP group improved significantly compared to the values observed in the E group at any time point (p < 0.05).ConclusionsThe EP treatment was more effective in preventing variceal rebleeding and variceal recurrence than the conventional E treatment during the secondary prophylaxis of VH in cirrhosis patients with hypersplenism. Furthermore, the EP treatment could significantly increase the peripheral blood cell count and albumin concentration and also improved the coagulation function and the Child-Pugh score.Clinical trials registrationTrial registration number ClincialTrials.gov: NCT02778425. The URL of the clinical trial: https://clinicaltrials.gov/.

Dataset Information

A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial.

Publications

A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial.

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