RESUMO
BACKGROUND: This study aimed to compare oral sulfate solution (OSS) with polyethylene glycol (PEG) for bowel preparation before colonoscopy. METHODS: A literature search was performed on PubMed, Ovid, and Cochrane Databases for randomized clinical trials (RCT) comparing OSS with PEG for bowel preparation before colonoscopy. The last search was performed on 22 August 2023. The primary outcome was the quality of bowel preparation. The outcomes were compared by meta-analysis and trial sequential analysis (TSA). RESULTS: A total of 14 RCTs with 4526 patients were included. OSS was comparable with PEG regarding adequate bowel preparation [P = 0.16, odds ratio (OR) = 1.19, 95% confidence interval (CI) [0.93, 1.51], I2 = 0%]. However, OSS showed obvious priority in excellent bowel preparation (P < 0.001, OR = 1.62, 95% CI [1.27, 2.05], I2 = 0%) and total Boston bowel preparation scale (BBPS) [P = 0.02, weighted mean difference (WMD) = 0.27, 95% CI [0.05, 0.50], I2 = 84%]. Additionally, the detection rate of polyps (P = 0.001, OR = 1.44, 95% CI [1.15, 1.80], I2 = 0%) and adenoma (P = 0.007, OR = 1.22, 95% CI [1.06, 1.42], I2 = 0%) was significantly higher in the OSS group. The two groups showed comparable incidence of adverse events except for a higher incidence of dizziness (P = 0.02, OR = 1.74, 95% CI [1.08, 2.83], I2 = 11%) was indicated in the OSS group. Moreover, OSS was associated with a higher satisfaction score (P = 0.02, WMD = 0.62, 95% CI [0.09, 1.15], I2 = 70%). In the TSA, the cumulative Z-curve crossed both the conventional boundary and trial sequential monitoring boundary and the required information size has been reached for excellent bowel preparation and total BBPS. CONCLUSION: The current data demonstrated that OSS was associated with better quality of bowel preparation. More clinical trials are still needed to confirm other outcomes.
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Catárticos , Colonoscopia , Polietilenoglicóis , Ensaios Clínicos Controlados Aleatórios como Assunto , Sulfatos , Humanos , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/efeitos adversos , Colonoscopia/métodos , Catárticos/administração & dosagem , Catárticos/efeitos adversos , Sulfatos/administração & dosagem , Administração Oral , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Cuidados Pré-Operatórios/métodos , Idoso , Pólipos do ColoAssuntos
Ácido Ascórbico , Catárticos , Polietilenoglicóis , Comprimidos , Humanos , Catárticos/administração & dosagem , Catárticos/efeitos adversos , Polietilenoglicóis/administração & dosagem , Idoso , Administração Oral , Ácido Ascórbico/administração & dosagem , Sulfatos/administração & dosagem , Colonoscopia/métodosRESUMO
INTRODUCTION: Constipation is an independent risk factor for poor bowel preparation. This study aimed to evaluate the bowel cleansing efficacy and safety of polyethylene glycol (PEG) combined with linaclotide (lin) for colonoscopy in patients with chronic constipation (CC). METHODS: This single-blinded, randomized, controlled, and multicenter study was conducted from July 2021 to December 2022 at 7 hospitals. Patients with CC who underwent colonoscopies were enrolled and randomly assigned to 4 groups with split-PEG regimens: 4L-PEG group, 4L-PEG+1d-Lin group, 3L-PEG+1d-Lin group, and 3L-PEG+3d-Lin group. The primary outcome was rates of adequate bowel preparation, defined as a total BBPS score ≥6 and a score ≥2 for each segment. Secondary outcomes were adverse effects, sleep quality, willingness to repeat the colonoscopy, adenoma detection rate, and polyp detection rate. RESULTS: Five hundred two patients were enrolled. The rates of adequate bowel preparation (80.0% vs 60.3%, P < 0.001; 84.4% vs 60.3%, P < 0.001) and the total Boston Bowel Preparation Scale (BBPS) scores (6.90 ± 1.28 vs 6.00 ± 1.61, P < 0.001; 7.03 ± 1.24 vs 6.00 ± 1.61, P < 0.01) in the 4L-PEG+1d-Lin group and the 3L-PEG+3d-Lin group were superior to that in the 4L-PEG group. Compared with the 4L-PEG group, the 4L-PEG+1d-Lin group (66.7% vs 81.7%, P = 0.008) and the 3L-PEG+3d-Lin group (75.0% vs 81.7%, P = 0.224) had a lower percentage of mild adverse events. No statistically significant difference in willingness to repeat the colonoscopy, sleep quality, polyp detection rate, or adenoma detection rate was observed among groups. DISCUSSION: PEG combined with linaclotide might be an effective method for bowel preparation before colonoscopy in patients with CC.
Assuntos
Catárticos , Colonoscopia , Constipação Intestinal , Polietilenoglicóis , Humanos , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/efeitos adversos , Masculino , Feminino , Constipação Intestinal/diagnóstico , Pessoa de Meia-Idade , Método Simples-Cego , Catárticos/administração & dosagem , Catárticos/efeitos adversos , Doença Crônica , Idoso , Adulto , Peptídeos/administração & dosagem , Peptídeos/efeitos adversos , Pós , Resultado do Tratamento , Eletrólitos/administração & dosagem , Eletrólitos/efeitos adversosRESUMO
OBJECTIVE: The purpose of this study is to evaluate the safety and efficacy of linaclotide and polyethylene glycol (PEG) electrolyte powder in patients with chronic constipation undergoing colonoscopy preparation. PATIENTS AND METHODS: We included 260 patients with chronic constipation who were scheduled to undergo a colonoscopy. They were equally divided into 4 groups using a random number table: 4L PEG, 3L PEG, 3L PEG+L, and 2L PEG+L. The 4 groups were compared based on their scores on the Boston Bowel Preparation Scale (BBPS) and Ottawa Bowel Preparation Quality Scale (OBPQS), adverse reactions during the bowel preparation procedure, colonoscope insertion time, colonoscope withdrawal time, detection rate of adenomas, and their willingness to repeat bowel preparation. RESULTS: In terms of the score of the right half of the colon, the score of the transverse colon, the total score using BBPS, and the total score using OBPQS, the 3L PEG (polyethylene glycol)+L group was superior to groups 3L PEG and 2L PEG+L ( P <0.05), but comparable to the 4L PEG group ( P >0.05). The incidence rate of vomiting was higher in the 4L PEG group than in the 2L PEG+L group ( P <0.05). There was no statistically significant difference in the insertion time of the colonoscope between the 4 groups. The colonoscope withdrawal time in the 3L PEG+L group was shorter than in groups 4L PEG and 3L PEG ( P <0.05) and comparable to that in the 4L PEG group ( P >0.05). There was no statistically significant difference in the rate of adenoma detection among the 4 groups ( P >0.05). The 4L PEG group was the least willing of the 4 groups to undergo repeated bowel preparation ( P <0.05). CONCLUSION: The 3L PEG+L is optimal among the 4 procedures. It can facilitate high-quality bowel preparation, reduce the incidence of nausea during the bowel preparation procedure, and encourage patients to undertake repeated bowel preparation.
Assuntos
Catárticos , Constipação Intestinal , Peptídeos , Humanos , Catárticos/efeitos adversos , Pós , Constipação Intestinal/diagnóstico , Constipação Intestinal/induzido quimicamente , Polietilenoglicóis , Colonoscopia/métodos , EletrólitosRESUMO
BACKGROUND: We compared the efficacy, tolerability, and safety of oral sulfate tablets (OST, which contains simethicone) and 2 L-polyethylene glycol/ascorbate (2 L-PEG/Asc) with a split-dosing regimen in older individuals aged ≥ 70 years who underwent scheduled colonoscopy. METHODS: This prospective, randomized, investigator-blinded, multicenter study was conducted between June 2022 and October 2023. Participants aged ≥ 70 years were randomized at a ratio of 1:1 to the OST or 2 L-PEG/Asc groups. RESULTS: In total, 254 patients were evaluated using a modified full analysis set. Successful overall bowel preparation was excellent and similar between the OST and 2 L-PEG/Asc groups for the Boston Bowel Preparation Scale (BBPS) (96.5% vs. 96.6%) and Harefield Cleansing Scale (HCS) (96.5% vs. 97.4%). The overall high-quality preparation rate was higher in the OST group than in the 2 L-PEG/Asc group (BBPS: 55.7% vs. 28.4%, P < 0.001; HCS: 66.1% vs. 38.8%, P < 0.001). The overall adenoma detection rate (54.8% vs. 35.3, P = 0.003) was superior in the OST group compared to the 2 L-PEG/Asc group. Tolerability scores, including overall satisfaction, were generally higher in the OST group than in the 2 L-PEG/Asc group. The incidence of major solicited adverse events was comparable between the two groups (55.7% vs. 68.1, P = 0.051), and there were no clinically significant changes in the serum laboratory profiles on the day of or 7 days after colonoscopy. CONCLUSIONS: OST is an effective and safe low-volume agent for colonoscopy, with better tolerance than 2 L-PEG/Asc, in older individuals aged ≥ 70 years.
Assuntos
Catárticos , Polietilenoglicóis , Humanos , Idoso , Polietilenoglicóis/efeitos adversos , Catárticos/efeitos adversos , Sulfatos , Estudos Prospectivos , Laxantes , Colonoscopia , Ácido Ascórbico/efeitos adversosRESUMO
BACKGROUND: This study aimed to determine the factors that contribute to the failure of bowel preparation in patients undergoing colonoscopy and to develop a risk prediction model. METHODS: A total of 1115 outpatients were included. Patients were randomly divided into two groups: the modeling group (669 patients) and the validation group (446 patients). In the modeling group, patients were further divided into two groups based on their success and failure in bowel preparation using the Boston Bowel Preparation Scale. A logistic regression analysis model was used to determine the risk factors of bowel preparation failure, which was subsequently visualized using an alignment diagram. RESULTS: After controlling for relevant confounders, multifactorial logistic regression results showed that age ≥ 60 years (OR = 2.246), male (OR = 2.449), body mass index ≥ 24 (OR = 2.311), smoking (OR = 2.467), chronic constipation (OR = 5.199), diabetes mellitus (OR = 5.396) and history of colorectal surgery (OR = 5.170) were influencing factors of bowel preparation failure. The area under the ROC curve was 0.732 in the modeling group and 0.713 in the validation group. According to the calibration plot, the predictive effect of the model and the actual results were in good agreement. CONCLUSIONS: Age ≥ 60 years, male, body mass index ≥ 24, smoking, chronic constipation, diabetes mellitus, and history of colorectal surgery are independent risk factors for bowel preparation failure. The established prediction model has a good predictive efficacy and can be used as a simple and effective tool for screening patients at high risk for bowel preparation failure.
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Catárticos , Diabetes Mellitus , Humanos , Masculino , Pessoa de Meia-Idade , Catárticos/efeitos adversos , Colonoscopia/métodos , Constipação Intestinal , Fatores de Risco , Distribuição Aleatória , FemininoRESUMO
BACKGROUND AND AIM: The study aims to evaluate the feasibility of body mass index (BMI)-based individualized small bowel preparation for computed tomography enterography (CTE). METHODS: In this prospective randomized controlled study, patients undergoing CTE were randomly assigned to the individualized group or standardized group. Those in individualized group were given different volumes of mannitol solution based on BMI (1000 mL for patients with BMI < 18.5 kg/m2, 1500 mL for patients with 18.5 kg/m2 ≤ BMI < 25 kg/m2 and 2000 mL for patients with BMI ≥ 25 kg/m2) while patients in the standardized group were all asked to consume 1500-mL mannitol solution. CTE images were reviewed by two experienced radiologists blindly. Each segment of the small bowel was assessed for small bowel image quality and disease detection rates. Patients were invited to record a diary regarding adverse events and acceptance. RESULTS: A total of 203 patients were enrolled and randomly divided into two groups. For patients with BMI < 18.5 kg/m2, 1000-mL mannitol solution permitted a significantly lower rate of flatulence (P = 0.045) and defecating frequency (P = 0.011) as well as higher acceptance score (P = 0.015), but did not affect bowel image quality and diseases detection compared with conventional dosage. For patients with BMI ≥ 25 kg/m2, 2000-mL mannitol solution provided better overall image quality (P = 0.033) but comparable rates of adverse events and patients' acceptance compared with conventional dosage. CONCLUSIONS: Individualized bowel preparation could achieve both satisfactory image quality and patients' acceptance thus might be an acceptable alternative in CTE.
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Índice de Massa Corporal , Intestino Delgado , Manitol , Tomografia Computadorizada por Raios X , Humanos , Feminino , Masculino , Estudos Prospectivos , Pessoa de Meia-Idade , Manitol/administração & dosagem , Manitol/efeitos adversos , Tomografia Computadorizada por Raios X/métodos , Intestino Delgado/diagnóstico por imagem , Adulto , Idoso , Estudos de Viabilidade , Catárticos/administração & dosagem , Catárticos/efeitos adversos , Medicina de PrecisãoRESUMO
BACKGROUND: Adequate bowel preparation is a prerequisite for colonoscopy. However, up to 20% of colonoscopies remain inadequately prepared. Risk factors for inadequate bowel preparation often overlap with those of failed cecal intubation. This study aimed to assess the feasibility of an intraprocedural bowel cleansing system (BCS) in patients with a history of inadequate bowel preparation. METHODS: Patients (n = 44) with a history of inadequate bowel preparation in the past 2 years were included. After a limited preparation with 300 mL split-dose sodium picosulfate magnesium citrate, additional cleansing during colonoscopy was performed with the BCS. The primary outcome was adequate bowel preparation using the Boston Bowel Preparation Scale (BBPS). Secondary outcomes included cecal intubation rate, procedure times, usability, and safety. RESULTS: Median BBPS increased from 1-2-2 (IQR 1-2) to 3-3-3 (IQR) (p < 0.0001), with 31.8% and 88.6% of patients adequately prepared before and after using the BCS, respectively (p < 0.0001). Cecal intubation rate was 88.6%. Reasons for incomplete colonoscopy were looping (n = 2), technical failure (n = 1), relative stricture (n = 1), and residual feces (n = 1). In patients with complete colonoscopy, the adequate cleansing rate was 97.5%. Median total procedure time was 26 min, of which 5.3 min were spent on cleaning. General ease of use was scored with a median of 4 out of 5, representing "as good as conventional colonoscopy". No serious adverse events occurred. CONCLUSIONS: Adequate bowel cleaning can be achieved with an intraprocedural BCS in patients with a history of inadequate bowel preparation, which may reduce repeat colonoscopies and clinical admissions for bowel preparation. However, since these patients more frequently have complicated anatomy (surgical scarring, diverticulosis, etc.), adequate patient selection is advised to avoid incomplete procedures.
Assuntos
Catárticos , Colonoscopia , Humanos , Colonoscopia/métodos , Catárticos/efeitos adversos , Estudos de Viabilidade , Ceco , Estudos ProspectivosRESUMO
BACKGROUND AND AIM: Although studies have shown that the quality of bowel preparation with low-residue diet (LRD) is as effective as that of clear fluid diet (CLD), there is currently no consensus on how long an LRD should last. The aim of this study was to compare a 1-day versus 3-day LRD on bowel preparation before colonoscopy. METHODS: A systematic review search was conducted in MEDLINE/PubMed, EMBASE, Web of Science, and Cochrane database from inception to April 2023. We identified randomized controlled trials (RCTs) that compared 1-day with 3-day LRD bowel cleansing regiments for patients undergoing colonoscopy. The rate of adequate bowel preparation, polyp detection rate, adenoma detection rate, tolerability, willingness to repeat preparation, and adverse events were estimated using odds ratios (OR) and 95% confidence interval (CI). We also performed meta-analysis to identify risk factors and predictors of inadequate preparation. RESULTS: Four studies published between 2019 and 2023 with 1927 participants were included. The present meta-analysis suggested that 1-day LRD was comparable with 3-day LRD for adequate bowel preparation (OR 0.89; 95% CI, 0.65-1.21; P = 0.45; I2 = 0%; P = 0.52). The polyp detection rate (OR 0.94; 95% CI, 0.77-1.14; P = 0.52; I2 = 23%; P = 0.27) and adenoma detection rate (OR 0.87; 95% CI, 0.71-1.08; P = 0.21; I2 = 0%; P = 0.52) were similar between the groups. There were significantly higher odds of tolerability in patients consuming 1-day LRD compared with 3-day LRD (OR 1.64; 95% CI, 1.13-2.39; P < 0.01; I2 = 47%; P = 0.15). In addition, constipation was identified as the independent predictor of inadequate preparation (OR 1.98; 95% CI, 1.27-3.11; P < 0.01; I2 = 0%; P = 0.46). CONCLUSION: The present study demonstrated that a 1-day LRD was as effective as a 3-day CLD in the quality of bowel preparation before colonoscopy and significantly improved tolerability of patients. In addition, constipation is an independent risk factor of poor bowel preparation, and the duration of LRD in patients with constipation still needs further clinical trials.
Assuntos
Catárticos , Colonoscopia , Ensaios Clínicos Controlados Aleatórios como Assunto , Colonoscopia/métodos , Humanos , Catárticos/administração & dosagem , Catárticos/efeitos adversos , Fatores de Tempo , Dieta , Adenoma/diagnóstico , Feminino , Masculino , Cuidados Pré-Operatórios/métodosRESUMO
INTRODUCTION: Colonoscopy is currently considered as one of the principal techniques to diagnose the colorectal diseases. Admittedly, qualified bowel preparation before colonoscopy is a premise for high-quality examination. Lower quality bowel preparation might seriously impede visualization of the intestinal mucosa, resulting in missed and misdiagnosed intestinal lesions. Therefore, it is necessary to choose the appropriate oral laxative based on the guarantee of safety and efficacy. METHODS: This prospective randomized controlled study was conducted to compare lactulose oral solution and polyethylene glycol (PEG) electrolyte powder for bowel preparation using the following indicators: Boston Bowel Preparation Scale, Bowel Bubble Score, detection rate of adenoma and lesion, patients' satisfaction, and adverse effects. Our study investigated the suitability of 2 bowel preparation reagents for patients with different body mass indices mainly based on body mass index (BMI). RESULTS: In the lactulose group, there was a significant improvement in the quality of bowel preparation compared with those in the PEG group ( P < 0.05), especially in people with normal BMI and higher BMI. Compared with the PEG group, individuals in the lactulose group had a significantly higher adenoma detection rate (50% vs 33.5%, P < 0.05) and taste scores (8.82 vs 6.69, P < 0.05), as well as significantly fewer adverse reactions (6.5% vs 32.5%, P < 0.05). DISCUSSION: Lactulose oral solution is superior to PEG in bowel preparation quality and taste, especially in normal BMI and higher BMI groups. It can be used clinically as a potential and promising bowel preparation agent in the future. Clinical Trial registration number: ChiCTR2100054318.
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Adenoma , Polietilenoglicóis , Humanos , Polietilenoglicóis/efeitos adversos , Lactulose/efeitos adversos , Catárticos/efeitos adversos , Índice de Massa Corporal , Estudos Prospectivos , Colonoscopia/métodosRESUMO
AIMS: An easy-to-use preparation-related model (PRM) predicting inadequate bowel preparation (BP) was developed and proved superior to traditional models in our previous study. Here we aimed to investigate whether PRM-based individualized intervention can improve BP adequacy. METHODS: Patients undergoing morning colonoscopy were prospectively enrolled in 5 endoscopic centers in China. After standard BP of split-dose polyethylene glycol (PEG) was completed, patients were randomized (1:1) to the individualized group or standard group. High-risk patients predicted by PRM score ≥3 were instructed to drink an additional 1.5 L PEG in the individualized group while not in standard group. The primary endpoint was the rate of adequate BP, defined by segmental Boston bowel preparation scale ≥2. Secondary outcomes included adenoma detection rate (ADR) and adverse events. RESULTS: 900 patients were randomly allocated to the individualized group (n = 449) and the control (n = 451). Baseline characteristics were similar between the two groups. The rates of high-risk patients were 19.6 % in individualized group and 19.7 % in standard group. In intention-to-treat analysis, adequate BP was 91.8 % in individualized group and 84.7 % in the standard group (p = 0.001). Among high-risk patients, adequate BP rate was 94.3 % in individualized group and 49.3 % in standard group (p < 0.001), and ADR were 40.9 % vs 16.9 %, respectively (p < 0.001). No significant differences were found regarding the adverse events and willingness to repeat BP (all p >0.05). CONCLUSIONS: The individualized intervention using an additional dose of PEG to high-risk patients predicted by PRM, significantly improved BP quality. The intervention significantly improved ADR in high-risk patients. (ClinicalTrials.gov number: NCT04434625).
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Adenoma , Catárticos , Humanos , Catárticos/efeitos adversos , Estudos Prospectivos , Polietilenoglicóis/efeitos adversos , Colonoscopia , Projetos de Pesquisa , Adenoma/diagnósticoRESUMO
BACKGROUND: adequate bowel preparation is related to the quality of colonoscopy. Dried lemon slices can increase gastrointestinal peristalsis, which has shown potential as an adjuvant of bowel preparation. We hypothesized that the combination of dried lemon slices and polyethylene glycol (PEG) could improve the efficacy of bowel preparation and be more acceptable to participants. AIM: to investigate the effectiveness of lemon slices combined with PEG for colonoscopy preparation. METHODS: a prospective, single-center, randomized, controlled trial was performed of 521 patients randomly assigned to two groups. A total of 254 patients were given lemon slices based on conventional 4-L PEG treatment for the bowel, while 267 patients received only 4-L PEG treatment. Patients' basic information, procedure-related parameters, adverse effects, and subjective feelings were collected by questionnaires. Intestinal tract cleanliness was scored according to the Boston Bowel Preparation Scale (BBPS) by experienced endoscopists. Data were analyzed by the two-sample t-test or the Chi-squared test. RESULTS: the BBPS scores were significantly higher in the PEG + lemon slice group (p < 0.05). The taste acceptability, satisfaction, and willingness to repeat bowel preparation were significantly higher in the PEG+ lemon slice group (p < 0.05). However, a larger proportion of patients from the PEG+ lemon slice group (30.7 %) suffered abdominal distension compared with the PEG group (20.6 %), while the incidence of other adverse effects was comparable between the two groups. CONCLUSION: the addition of dried lemon slices to conventional PEG showed its superiority for bowel preparation.
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Catárticos , Polietilenoglicóis , Humanos , Catárticos/efeitos adversos , Estudos Prospectivos , Satisfação do Paciente , ColonoscopiaRESUMO
BACKGROUND: adequate bowel preparation is crucial for the protective effect of colonoscopy. Commonly used preparation regimens like polyethylene glycol (PEG) or sodium picosulfate with magnesium citrate (SPMC) have shown similar results in clinical trials, but low-volume PEG + ascorbic acid (1-L PEG + ASC) versus SPMC have never been compared in a real-life setting. AIM: to evaluate the effectiveness and safety of 1-L PEG + ASC versus SPMC in a real-life setting for the overall population, for patients aged ≥ 65 years, and males versus females. METHODS: out-patients aged ≥ 18 years who underwent colonoscopy for any indication were randomly assigned to the 1-L PEG + ASC or SPMC group. Using the Boston Bowel Preparation Scale (BBPS), the primary endpoints were the bowel cleansing success of the overall colon and right colon, as well as high-quality (HQ) cleansing. Furthermore, the effectiveness and safety outcomes for age groups and males versus females were compared. RESULTS: 1-L PEG + ASC showed significantly better bowel cleansing success than SPMC. Particularly remarkable is the HQ cleansing reached with 1-L PEG + ASC compared with SPMC (55.5 % versus 25.4 % in the overall colon, and 58.7 % versus 27.2 % in the right colon). 1-L PEG + ASC was equally effective for men and women while SPMC showed significant differences between genders (men had worse bowel cleansing). Age did not affect the cleansing effectiveness. 1-L PEG + ASC versus SPMC showed significant differences in tolerance and safety; women also had significantly worse tolerance than men for both solutions, but these did not affect the quality of bowel cleansing. CONCLUSIONS: in our real-life setting, 1-L PEG + ASC offered better adequate and HQ bowel cleansing than SPMC, achieving excellent cleansing quality, regardless of gender or tolerance.
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Catárticos , Citratos , Ácido Cítrico , Compostos Organometálicos , Picolinas , Polietilenoglicóis , Feminino , Humanos , Masculino , Catárticos/efeitos adversos , Ácido Ascórbico/farmacologia , Colonoscopia/métodosRESUMO
BACKGROUND AND AIMS: Adequate bowel cleansing is essential for colonoscopy quality. A novel 1 L polyethylene glycol plus ascorbate (1 L PEG+ASC) solution has been recently introduced. Nevertheless, the efficacy of 1 L PEG+ASC as compared to that of high-volume bowel preparation in both inpatients and outpatients is still unclear. PATIENTS AND METHODS: This single-blinded, non-inferiority study randomized patients undergoing colonoscopy to receive split-dose 1 L PEG+ASC or 4 L PEG. The primary endpoint was the overall cleansing success. Secondary endpoints were excellent cleansing and high-quality cleansing of the right colon, as well as lesions detection rate, patient compliance, tolerability and safety. RESULTS: Overall, 478 patients were randomized to 1 L PEG+ASC (N = 236) or 4 L PEG (N = 242). The 1 L PEG+ASC showed higher cleansing success rate (91.8% vs 83.6%; P=0.01) and a high-quality cleansing of the right colon (52.3% and 38.5%; P=0.004) compared to 4 L PEG. Moreover, 1 L PEG+ASC achieved a higher cleansing success in out-patients (96.3%% vs 88.6%; P=0.018), and a similar success rate in the in-patients (84.7% vs 76.7%; P=0.18). Adenoma detection rate, tolerability and incidence of adverse events were comparable between preparations. CONCLUSIONS: The 1 L PEG+ASC showed higher efficacy in achieving adequate colon cleansing compared with 4 L PEG, particularly in the right colon. No differences in the tolerability and safety were detected.
Assuntos
Catárticos , Polietilenoglicóis , Humanos , Polietilenoglicóis/efeitos adversos , Catárticos/efeitos adversos , Colonoscopia , Laxantes , Colo , Ácido Ascórbico/efeitos adversosRESUMO
INTRODUCTION: Shankhaprakshalana (SP) is a yogic method aiming to cleanse the bowel. It involves the use of warm saline water and a combination of five asanas. This study was designed to assess the effectiveness and safety of bowel preparation by SP. METHODS: This is a retrospective observational study of prospectively collected data. Patients planned for colonoscopy were screened and enrolled to undergo bowel preparation by SP on the day of the colonoscopy. Patients having comorbid conditions, poor performance status, suspected or previously diagnosed intestinal stricture and past history of major abdominal surgery and those unable to perform asanas of SP were excluded. A low-fiber diet was advised for one day before the colonoscopy. Patients were advised to drink 400 mL of lukewarm saline water followed by five asanas (exercises) of SP, each done eight times dynamically and sequentially. After completing six such cycles, patients underwent colonoscopy. Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of bowel preparation. RESULTS: Total 238 patients were included. The major indications for colonoscopy were abdominal pain (35.3%), hematochezia (23.9%), diarrhea (20.2%), constipation (10.9%) and anemia (9.7%). The mean age was 37.7 (± 12) years. The mean BBPS was 8 (± 1.2). Bowel preparation was inadequate (BBPS < 6) in only two patients. Mean segmental BBPS for the three segments of the colon (right, transverse and left) was 2.6 (± 0.5), 2.7 (± 0.4) and 2.6 (± 0.7), respectively. Minor adverse events (nausea, abdominal pain, vomiting, giddiness and bloating) were noted in 10 participants (4.2%), which did not require hospitalization. Bowel preparation was completed in 133 (± 35) minutes. CONCLUSION: Shankhaprakshalana is an effective and safe method to achieve adequate bowel preparation before colonoscopy. Since this is a single-center and retrospective study, future multi-centric, prospective studies comparing it with the standard bowel preparation regimens are warranted.
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Colonoscopia , Humanos , Colonoscopia/métodos , Estudos Retrospectivos , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Catárticos/administração & dosagem , Catárticos/efeitos adversos , Adulto JovemRESUMO
BACKGROUND: Acceptability and tolerance of bowel preparation is critical to overcome patient hesitancy in undergoing colon cancer screening and surveillance colonoscopy. To improve patient experience, a new sports drink-flavored bowel preparation containing polyethylene glycol (PEG) and sulfate salts (FPSS) was developed to provide a similar experience to a commonly used but not United States Food and Drug Administration (FDA) approved PEG and sports drink bowel preparation (PEG-SD), while also achieving improved cleansing efficacy. METHODS: This FPSS preparation, approved by the FDA in June 2023, was evaluated in a non-randomized Phase 2 study in which 40 patients requiring colonoscopy were prepared with FPSS and 20 with PEG-SD. RESULTS: Overall cleansing success was high with FPSS based on unblinded local endoscopist assessment (93%) and blinded central reading (97%), exceeding PEG-SD which achieved success rates of 84% (local read), 74% and 68% (blinded central reads). Similar differences favoring FPSS were seen for excellent preparations and cleansing success by colon segment as rated by local endoscopists. Both preparations were well-tolerated, with 93% of FPSS patients rating their preparation as Tolerable to Very Easy to consume, compared to 100% of PEG-SD. Patients who had previously taken a preparation for colonoscopy found FPSS and PEG-SD better than their prior preparation (73% and 70%, respectively) and nearly all would request their assigned study preparation again in the future. About two thirds of FPSS patients agreed that the preparation tasted similar to a sports drink. CONCLUSION: The new sports drink-like flavored preparation compares favorably to PEG-SD for bowel cleansing efficacy while achieving similar patient satisfaction. The study was registered at www. CLINICALTRIALS: gov (NCT03328507) on 01/11/2017.
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Catárticos , Laxantes , Humanos , Catárticos/efeitos adversos , Sulfatos , Polietilenoglicóis/efeitos adversos , ColonoscopiaRESUMO
Patients with inflammatory bowel diseases (IBDs) require repeated endoscopic evaluations over time by colonoscopy to weigh disease activity but also for different and additional indications (e.g., evaluation of postoperative recurrence, colorectal cancer surveillance). Colonoscopy, however, requires adequate bowel preparation to be of quality. The latter is achieved as long as the patient takes a certain amount of product to have a number of bowel movements suitable to clean the colon and allow optimal visualization of the mucosa during endoscopy. However, significant guidelines recommend preparations for patients with IBD not excelling in palatability. This recommendation originates from the fact that most of the studies conducted on bowel preparations in patients with IBD have been done with isosmolar preparations based on polyethylene glycol (PEG), for which, therefore, more safety data exist. As a result, the low-volume non-PEG preparations (e.g., magnesium citrate plus picosulphate, oral sulphate solutions) have been set aside for the whole range of warnings to be heeded because of their hyperosmolarity. New studies, however, are emerging, leaning in overall for a paradigm shift in this matter. Indeed, such non-PEG preparations seem to show a particularly encouraging and engaging safety profile when considering their broad potential for tolerability and patient preference. Indeed, such evidence is insufficient to indicate such preparations in all patients with IBD but may pave the way for those with remission or well-controlled disease. This article summarizes the central studies conducted in IBD settings using non-PEG preparations by discussing their results.
Assuntos
Catárticos , Doenças Inflamatórias Intestinais , Humanos , Catárticos/efeitos adversos , Polietilenoglicóis/efeitos adversos , Colonoscopia/métodos , Doenças Inflamatórias Intestinais/tratamento farmacológicoRESUMO
BACKGROUND AND AIM: Low-volume bowel preparation solutions, including 1-L polyethylene glycol plus ascorbate (PEG-A), have been developed to improve tolerability. The oral sodium sulfate tablet (OST) is a new agent with simethicone as a preloaded component. We investigated the efficacy, safety, and tolerability of OST compared to 1-L PEG-A. METHODS: A single-center, prospective, controlled study was performed with randomization into the OST (group A) and 1-L PEG-A (group B) groups. Bowel preparation efficacy was assessed on the Boston Bowel Preparation Scale (BBPS) and Bubble Scale. Safety and tolerability were evaluated using a questionnaire and laboratory examination. RESULTS: Final analysis was performed on 171 patients (group A: 87, group B: 84). The proportion of bowel preparation success (BBPS ≥ 2 for each colonic segment) in group A was not inferior compared to group B (95.4% vs 96.4%, P = 0.736, 1-sided 97.5% lower confidence limit -7.0%). The adenoma detection rate was not different (59.6% vs 41.9%; P = 0.087). The bubble scale was better in group A (0.2 ± 0.9 vs 1.9 ± 1.7, P < 0.001). All adverse events were mild in both groups. Nausea was less frequent in group A (14.9% vs 38.1%, P = 0.001). Overall satisfaction was better in group A (8.1 ± 2.1 vs 6.4 ± 2.8, P < 0.001). No clinically significant laboratory abnormality developed in both groups. These findings were similarly shown in old patients ≥65 years. CONCLUSIONS: Both OST and 1-L PEG-A were efficacious, safe, and tolerable for bowel preparation of colonoscopy. The OST showed fewer bubbles and slightly better tolerability.
Assuntos
Catárticos , Polietilenoglicóis , Humanos , Polietilenoglicóis/efeitos adversos , Estudos Prospectivos , Catárticos/efeitos adversos , Colo , Colonoscopia , Ácido Ascórbico/efeitos adversosRESUMO
Objective: Split-dose polyethylene glycol (PEG) is routinely used for bowel preparation before colonoscopy. This study aimed to investigate the composition of gut microbiota and its functions in pediatric patients undergoing split-dose PEG bowel preparation for colonoscopy to understand the stability and resilience of gut microbiota. Material and methods: From September to December 2021, 19 pediatric patients were enrolled at Shenzhen Children's Hospital and 76 samples (4 time points) were analyzed using metagenomics. Time points included Time_1 (one day before bowel preparation), Time_2 (one day after colonoscopy), Time_3 (two weeks after bowel preparation), and Time_4 (four weeks after bowel preparation). Result: Alpha diversity comparison at both the species and gene levels showed a decrease in community richness after colonoscopy, with little statistical significance. However, the Shannon diversity index significantly decreased (P<0.05) and gradually returned to pre-preparation levels at two weeks after bowel preparation. The genus level analysis showed six genera (Eubacterium, Escherichia, Intertinibacter, Veillonella, Ruminococcaceae unclassified, and Coprobacillus) significantly different across the four time periods. Additionally, at the species level, the abundance of Escherichia coli, Bacteroides fragilis, and Veillonella parvula significantly increased at one day after colonoscopy before gradually decreasing at two weeks after bowel preparation. In contrast, the abundance of Intertinibacter bartlettii decreased at one day after colonoscopy but then recovered at two weeks after bowel preparation, reaching the preoperative level at four weeks after bowel preparation. Furthermore, five functional pathways (base excision repair, biosynthesis of ansamycins, biosynthesis of siderophore group nonribosomal peptide, flavonoid biosynthesis, and biosynthesis of type II polyketide products) were significantly different across the four time periods, with recovery at two weeks after bowel preparation and reaching preoperative levels at four weeks after bowel preparation. Conclusions: Gut microbiota at the genus level, species level, and functional pathways are impacted in pediatric patients undergoing split-dose PEG bowel preparation and colonoscopy, with recovery two weeks following bowel preparation. However, the phylum level was not impacted. Modifications in gut microbiota composition and function may be investigated in future studies of bowel preparation. This study highlights the stability and resilience of gut microbiota among pediatric patients during bowel preparation.
Assuntos
Catárticos , Microbioma Gastrointestinal , Humanos , Criança , Catárticos/efeitos adversos , Metagenômica , Polietilenoglicóis , Colonoscopia/efeitos adversosRESUMO
BACKGROUND: A hyperosmolar ascorbic acid-enriched polyethylene glycol-electrolyte (ASC-PEG) lavage solution ensures excellent bowel preparation before colonoscopy; however, no study has demonstrated the efficacy of this lavage solution before surgery. This study aimed to establish the non-inferiority of ASC-PEG to the standard polyethylene glycol-electrolyte solution (PEG-ELS) in patients undergoing laparoscopic resection for colorectal cancer. METHODS: This was a prospective, single-blind, multicenter, randomized, controlled, non-inferiority clinical trial. Overall, 188 patients scheduled for laparoscopic colorectal resection for single colorectal adenocarcinomas were randomly assigned to undergo preparation with different PEG solutions between August 2017 and April 2020 at four hospitals in Japan. Participants received ASC-PEG (Group A) or PEG-ELS (Group B) preoperatively. The primary endpoint was the ratio of successful bowel preparations using the modified Aronchick scale, defined as "excellent" or "good." RESULTS: After exclusion, 86 and 87 patients in Groups A and B, respectively, completed the study, and their data were analyzed. ASC-PEG was not inferior to PEG-ELS in terms of effective bowel preparation prior to laparoscopic colorectal resection (0.93 vs. 0.92; 95% confidence interval, - 0.078 to 0.099, p = 0.007). The total volume of cleansing solution intake was lower in Group A than in Group B (1757.0 vs. 1970.1 mL). Two and three severe postoperative adverse events occurred in Groups A and B, respectively. Patient tolerance of the two solutions was almost equal. CONCLUSIONS: ASC-PEG is effective for preoperative bowel preparation in patients undergoing laparoscopic resection for colorectal cancer and is non-inferior to PEG-ELS.