Adenoma detection rate and tolerability of two ultra-low volume bowel preparations in screening: a noninferiority randomized controlled trial.

BACKGROUND AND AIMS: The adenoma detection rate (ADR), recognized as a surrogate marker for colorectal cancer incidence and mortality reduction, is closely linked to the efficacy of bowel cleansing. However, there is a dearth of evidence examining the impact on ADR when employing two distinct very low-dose bowel cleansing products. This study sought to compare ADR in a fecal immunochemical occult blood testing (iFOBT) based organized screening program by utilizing 1L polyethylene glycol plus ascorbate (1L-PEGA) versus magnesium citrate plus picosulphate (SPMC), both administered in a split-dose regimen. METHODS: We conducted a comparative, parallel, randomized, noninferiority, and low-intervention clinical trial, the study targeted individuals from a population colorectal cancer screening program aged 50-69 with a positive iFOBT result scheduled for a work-up colonoscopy in the morning. Participants were randomized to either 1L-PEGA or SPMC for bowel cleansing. Main outcome was ADR. Secondary outcomes were bowel preparation quality, individuals' safety, tolerability and satisfaction. RESULTS: A total of 1,002 subjects were included, 501 in each group. There were no differences between groups with respect to pooled ADR (SPMC, 56.5% [52.1-60.8]; 1L-PEGA, 53.7% [49.3-58.0]; RR 0.95 [0.85-1.06]); therefore, SPMC demonstrated noninferiority in ADR compared to 1L-PEGA (difference, 2.8%; 2-sided 95% lower confidence limit (LCL), -3.4). In addition, there were no significant differences in mean lesions regardless of size and location between arms. Bowel preparation favored 1L-PEGA (96.2% vs. 89.2%; p<0.001) whereas SPMC exhibited significantly higher safety and tolerability, as evidenced by fewer non-serious treatment-emergent adverse events CONCLUSIONS: SPMC emerged as a noninferior laxative compared to 1L-PEGA concerning ADR. Despite the superior bowel preparation quality associated with 1L-PEGA, the safety, tolerability and overall satisfaction of participants were higher with SPMC. This trial was registered at ClinicalTrials.gov (EudraCT: 2019-003186-18) on March 18, 2019.

A randomized prospective study comparing the effect of low-volume bowel preparations for colonoscopy preparation in China.

AIM: To evaluate the effect of sodium picosulfate/magnesium citrate (SPMC) and 3 L split-dose polyethylene glycol (PEG) with or without dimethicone on bowel preparation before colonoscopy. METHODS: In this multicenter, prospective, randomized, controlled study conducted from April 2021 to December 2021, consecutive adult patients scheduled for colonoscopy were prospectively randomized into four groups: SPMC, SPMC plus dimethicone, 3 L PEG, and 3 L PEG plus dimethicone. Primary endpoint was colon cleansing based on Boston Bowel Preparation Scale (BBPS). Secondary endpoints were bubble score, time to cecal intubation, adenoma detection rate (ADR), patient safety and compliance, and adverse events. RESULTS: We enrolled 223 and 291 patients in SPMC and 3 L PEG group, respectively. The proportion with acceptable bowel cleansing, total BBPS score and cecal intubation time were similar in all four subgroups (p > 0.05). Patient-reported acceptability and tolerability was significantly greater in SPMC than 3 L PEG group (p < 0.001); adverse events were significantly lower in SPMC than latter group (p < 0.001). ADR in both groups was greater than 30%. CONCLUSION: SPMC had significantly higher acceptability and tolerability than 3 L PEG, however, was similar in terms of bowel-cleansing effect and cecal intubation time and hence can be used before colonoscopy preparation.

A syrup containing L-arabinose and D-xylose appears superior to PEG-4000 as a bowel cleansing agent.

Adequate bowel cleansing is crucial for endoscopic diagnosis and treatment, and the recovery of gut microbiota after intestinal cleansing is also important. A hypertonic syrup predominantly comprising L-arabinose and D-xylose (20% xylo-oligosaccharides) can be extracted from the hemicellulose of corn husks and cobs. L-Arabinose and xylo-oligosaccharides have been reported to relieve constipation and improve the gut microbial environment. This study evaluated the bowel cleansing effect of the aforementioned syrup and its influence on the organism and intestinal microbiota after cleansing in comparison with polyethylene glycol-4000 (PEG-4000) in mice. Bowel cleansing was performed using syrup or PEG-4000 in C57BL/6J mice, and the effect of intestinal preparation and its influence on serum electrolytes and gut microbiota after bowel cleansing were evaluated. The volume of intestinal residual feces in the syrup group was significantly lower than that in the PEG-4000 group. Additionally, syrup disturbed serum electrolytes more mildly than PEG-4000. Alpha diversity in the gut microbiota was significantly higher in the syrup group than in the PEG-4000 group on the first day after bowel cleansing. However, no difference in beta diversity was observed between the two groups. Syrup increased the abundance of Bifidobacteria and Christensenella and decreased the abundance of Akkermansia in comparison with PEG-4000 on the first day after bowel cleansing. Thus, this syrup has potential clinical use as a bowel cleansing agent given the above effects, its benefits and safety, and better taste and acceptability.

Effect of bowel preparation completion time on bowel cleansing efficacy: Prospective randomized controlled trial of different bowel preparation completion times precolonoscopy.

OBJECTIVES: The elapse time between the completion of bowel cleansing and colonoscopy is one of the important factors for proper bowel cleansing. Although several studies have reported that a short time interval resulted in a favorable bowel cleansing, no randomized controlled trial (RCT) has been conducted to determine the effect of the elapse time. Consequently, we performed an RCT to investigate the efficacy of bowel preparation of participants who underwent colonoscopy according to the different time intervals between the completion of bowel preparation and colonoscopy. METHODS: In this single-center RCT, study participants were randomized to complete bowel preparation either 2-4 h or 4-8 h before colonoscopy. The primary end-point was successful bowel preparation, rated using the Boston Bowel Preparation Scale (BBPS). RESULTS: A total of 504 individuals were included (2-4 h, 255; 4-8 h, 249). The rate of successful bowel preparation in the 2-4 h group showed noninferiority compared with that of the 4-8 h group (97.6% vs. 95.2%; rate difference, 2.5% [-0.8% to 5.7%]; Pfor noninferiority < 0.001, Pfor superiority = 0.136). The rate for perfect cleansing (a BBPS score of 9) was higher in the 2-4 h group (56.5% vs. 39.8%, P < 0.001). CONCLUSION: When bowel cleansing was finished 2-4 h before the start of colonoscopy, the overall bowel cleansing was noninferior, and perfect cleansing was superior, compared to that when cleansing was finished 4-8 h before colonoscopy.

Impact of inadequate bowel cleansing in sigmoidoscopy screening.

BACKGROUND AND STUDY AIMS: Long-time follow-up of sigmoidoscopy screening trials has shown reduced incidence and mortality of colorectal cancer (CRC), but inadequate bowel cleansing may hamper efficacy. The aim of this study was to assess the impact of bowel cleansing quality in sigmoidoscopy screening. PATIENTS AND METHODS: Individuals 50 to 74 years old who had a screening sigmoidoscopy in a population-based Norwegian, randomized trial between 2012 and 2019, were included in this cross-sectional study. The bowel cleansing quality was categorised as excellent, good, partly poor, or poor. The effect of bowel cleansing quality on adenoma detection rate (ADR) and referral to colonoscopy was evaluated by fitting multivariable logistic regression models. RESULTS: 35,710 individuals were included. The bowel cleansing at sigmoidoscopy was excellent in 20,934 (58.6%) individuals, good in 6580 (18.4%), partly poor in 7097 (19.9%) and poor in 1099 (3.1%). The corresponding ADRs were 17.0%, 16.6%, 14.5%, and 13.0%. Compared to participants with excellent bowel cleansing, those with poor bowel cleansing had an odds ratio for adenoma detection of 0.66 (95% confidence interval 0.55-0.79). We found substantial differences in the assessment of bowel cleansing quality among endoscopists. CONCLUSIONS: Inadequate bowel cleansing reduces the efficacy of sigmoidoscopy screening, by lowering ADR. A validated rating scale and improved bowel preparation are needed to make sigmoidoscopy an appropriate screening method.Trial registration Clinicaltrials.gov (NCT01538550).

Design and validation of an artificial intelligence system to detect the quality of colon cleansing before colonoscopy / Diseño y validación de un sistema de inteligencia artificial para detectar la calidad de la limpieza del colon previa a la realización de la colonoscopia

Background and aims Patients’ perception of their bowel cleansing quality may guide rescue cleansing strategies before colonoscopy. The main aim of this study was to train and validate a convolutional neural network (CNN) for classifying rectal effluent during bowel preparation intake as “adequate” or “inadequate” cleansing before colonoscopy.Patients and methodsPatients referred for outpatient colonoscopy were asked to provide images of their rectal effluent during the bowel preparation process. The images were categorized as adequate or inadequate cleansing based on a predefined 4-picture quality scale. A total of 1203 images were collected from 660 patients. The initial dataset (799 images), was split into a training set (80%) and a validation set (20%). The second dataset (404 images) was used to develop a second test of the CNN accuracy. Afterward, CNN prediction was prospectively compared with the Boston Bowel Preparation Scale (BBPS) in 200 additional patients who provided a picture of their last rectal effluent.ResultsOn the initial dataset, a global accuracy of 97.49%, a sensitivity of 98.17% and a specificity of 96.66% were obtained using the CNN model. On the second dataset, an accuracy of 95%, a sensitivity of 99.60% and a specificity of 87.41% were obtained. The results from the CNN model were significantly associated with those from the BBPS (P<0.001), and 77.78% of the patients with poor bowel preparation were correctly classified.ConclusionThe designed CNN is capable of classifying “adequate cleansing” and “inadequate cleansing” images with high accuracy. (AU)

Antecedentes y objetivos La percepción de los pacientes sobre la calidad de su limpieza intestinal puede guiar las estrategias de limpieza de rescate antes de una colonoscopia. El objetivo principal de este estudio fue entrenar y validar una red neuronal convolucional (CNN) para clasificar el efluente rectal durante la preparación intestinal como «adecuado» o «inadecuado».Pacientes y métodosPacientes no seleccionados proporcionaron imágenes del efluente rectal durante el proceso de preparación intestinal. Las imágenes fueron categorizadas como una limpieza adecuada o inadecuada según una escala de calidad de 4 imágenes predefinida. Se recopilaron un total de 1.203 imágenes de 660 pacientes. El conjunto de datos inicial (799 imágenes) se dividió en un conjunto de entrenamiento (80%) y un conjunto de validación (20%). Un segundo conjunto de datos (404 imágenes) se utilizó para evaluar la precisión de la CNN. Posteriormente, la predicción de la CNN se comparó prospectivamente con la escala de preparación colónica de Boston (BBPS) en 200 pacientes que proporcionaron una imagen de su último efluente rectal.ResultadosEn el conjunto de datos inicial, la precisión global fue del 97,49%, la sensibilidad del 98,17% y la especificidad del 96,66%. En el segundo conjunto de datos, se obtuvo una precisión del 95%, una sensibilidad del 99,60% y una especificidad del 87,41%. Los resultados del modelo de CNN se asociaron significativamente con la escala de preparación colónica de Boston (p<0,001), y el 77,78% de los pacientes con una preparación intestinal deficiente fueron clasificados correctamente.ConclusiónLa CNN diseñada es capaz de clasificar imágenes de «limpieza adecuada» y «limpieza inadecuada» con alta precisión. (AU)

An intraprocedural bowel cleansing system for difficult-to-prepare patients-A multicenter prospective feasibility study.

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.

Design and validation of an artificial intelligence system to detect the quality of colon cleansing before colonoscopy.

BACKGROUND AND AIMS: Patients' perception of their bowel cleansing quality may guide rescue cleansing strategies before colonoscopy. The main aim of this study was to train and validate a convolutional neural network (CNN) for classifying rectal effluent during bowel preparation intake as "adequate" or "inadequate" cleansing before colonoscopy. PATIENTS AND METHODS: Patients referred for outpatient colonoscopy were asked to provide images of their rectal effluent during the bowel preparation process. The images were categorized as adequate or inadequate cleansing based on a predefined 4-picture quality scale. A total of 1203 images were collected from 660 patients. The initial dataset (799 images), was split into a training set (80%) and a validation set (20%). The second dataset (404 images) was used to develop a second test of the CNN accuracy. Afterward, CNN prediction was prospectively compared with the Boston Bowel Preparation Scale (BBPS) in 200 additional patients who provided a picture of their last rectal effluent. RESULTS: On the initial dataset, a global accuracy of 97.49%, a sensitivity of 98.17% and a specificity of 96.66% were obtained using the CNN model. On the second dataset, an accuracy of 95%, a sensitivity of 99.60% and a specificity of 87.41% were obtained. The results from the CNN model were significantly associated with those from the BBPS (P<0.001), and 77.78% of the patients with poor bowel preparation were correctly classified. CONCLUSION: The designed CNN is capable of classifying "adequate cleansing" and "inadequate cleansing" images with high accuracy.

Application status and views of common bowel cleansing regimens in China / 西安交通大学学报(医学版)

The quality of colonoscopy diagnosis and treatment is closely related to bowel cleansing. At present, polyethylene glycol electrolyte powder is the most widely used bowel cleaning regimen at home and abroad, but its intake is large, which reduces the compliance of patients. In recent years, many reports on the application of new bowel cleansing have emerged abroad. In contrast, the application of bowel cleanser in China is still relatively single, which has large room for improvement. At present, we need to solve the problem of developing a new bowel cleanser suitable for Chinese people to improve patient tolerance and bowel cleaning effect.

Predictive factors for inadequate bowel cleansing in colon capsule endoscopy / Factores predictores de limpieza colónica inadecuada en exploraciones con cápsula endoscópica de colon

Background and aims: Achieving adequate bowel cleansing is of utmost importance for the efficiency of colon capsule endoscopy (CCE). However, information about predictive factors is lacking. The aim of this study was to assess the predictive factors of poor bowel cleansing in the CCE setting. Methods: In this observational study, 126 patients who underwent CCE at two tertiary care hospitals were included between June 2017 and January 2020. Participants prepared for bowel cleansing with a 1-day clear liquid diet, a 4-L split-dose polyethylene glycol regimen and boosters with sodium phosphate, sodium amidotrizoate and meglumine amidotrizoate. Domperidone tablets and bisacodyl suppositories were administered when needed. Overall and per-segment bowel cleansing was evaluated using a CCE cleansing score. Simple and multiple logistic regression analysis were carried out to assess poor bowel cleansing and excretion rate predictors. Results: Overall bowel cleansing was optimal in 53 patients (50.5%). Optimal per-segment bowel cleansing was achieved as follows: cecum (86 patients; 74.8%), transverse colon (91 patients; 81.3%), distal colon (81 patients; 75%) and rectum (64 patients; 66.7%). In the univariate analysis, elderly (OR, 1.03; 95% CI (1.01–1.076)) and constipation (OR, 3.82; 95% CI (1.50–9.71)) were associated with poor bowel cleansing. In the logistic regression analysis, constipation (OR, 3.77; 95% CI (1.43–10.0)) was associated with poor bowel cleansing. No variables were significantly associated with the CCE device excretion rate. Conclusion: Our results suggest that constipation is the most powerful predictor of poor bowel cleansing in the CCE setting. Tailored cleansing protocols should be recommended for these patients.(AU)

Antecedentes y objetivos Lograr una limpieza intestinal adecuada es de gran importancia para la eficiencia de la cápsula endoscópica de colon (CEC). Se carece de información sobre factores predictivos. El objetivo fue evaluar los factores predictivos de la limpieza colónica deficiente en pacientes con CEC. Métodos: Ciento veintiséis pacientes fueron sometidos a CEC en dos hospitales de tercer nivel entre junio de 2017 y enero de 2020. La preparación consistió en un día de dieta líquida, y 4 l de polietilenglicol (dosis fraccionada), fosfato sódico, amidotrizoato de sodio y meglumina amidotrizoato. Ocasionalmente se administró domperidona y supositorios de bisacodilo. Se evaluó limpieza total y por segmentos. Se realizó un análisis de regresión logística simple y múltiple para evaluar factores de limpieza deficiente y de excreción de la CEC. Resultados: La limpieza intestinal fue óptima en 53 pacientes (50,5%). Por segmentos fue: ciego y ascendente (86 pacientes; 74,8%), transverso (91 pacientes; 81,3%), distal (81 pacientes; el 75%) y recto (64 pacientes; 66,7%). En la regresión simple, la edad avanzada (OR, 1,03, IC 95% [1,01-1,076]) y el estreñimiento (OR, 3,82; IC 95% [1,50-9,71]) se asociaron con una limpieza deficiente. El estreñimiento (OR, 3,77; IC del 95% [1,43-10,0]) fue el único factor asociado de forma independiente. Ninguna variable se asoció a la tasa de excreción de la CEC. Conclusión: Nuestros resultados sugieren que el estreñimiento es el factor más potente de la limpieza deficiente colónica en el estudio endoscópico con CEC. Protocolos de limpieza adaptados se deben recomendar en estos pacientes.(AU)

Increasing the low residue diet to 3 days does not improve the bowel cleansing in hard to prepare patients: Post hoc analysis of a randomized controlled trial / Aumentar la dieta baja en residuos a 3 días no mejora la limpieza intestinal en pacientes difíciles de preparar: análisis post-hoc de un ensayo controlado aleatorizado

Background: Recent evidence suggests that the number of low residue diet (LRD) days does not influence the bowel cleansing quality in non-selected patients. However, there are not data in the subgroup of patients with risk factors of inadequate bowel cleansing. Objective: The aim of this study was to assess whether a 3-day LRD improved the bowel cleansing quality in patients with risk factors of poor bowel cleansing. Patients and methods: Post hoc analysis of a randomized controlled trial carried out between December 2017 and March 2018 in a tertiary care hospital. Patients with high risk of poor bowel cleansing were selected following a validated score. The patients were randomized to the 1-day LRD or 3-day LRD groups. All patients received a 2-L split-dose of polyethylene glycol plus ascorbic acid. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the main outcome. Results: 135 patients (1-day LRD group=67, 3-day LRD=68) were included. The rate of adequate cleansing quality was not significantly different between the groups in the ITT analysis: 76.1%, 95% CI: [64.6–84.8] vs. 79.4%, 95% CI: [68.2–87.4]; odds ratio (OR) 1.2, 95% CI [0.54–2.73]) or in the PP analysis: 77.3%, 95% CI: [65.7–85.8] vs. 80.3%, 95% CI: [69.0–88.3]; OR 1.2, 95% CI [0.52–2.77]). Compliance with the diet or cleansing solution, satisfaction or difficulties with the LRD and the polyp/adenoma detection rates were not significantly different. Conclusion: Our results suggest that 1-day LRD is not inferior to 3-day LRD in patients with risk factors of inadequate bowel cleansing.(AU)

Antecedentes: La evidencia reciente sugiere que el número de días de dieta baja en residuos (DBR) no influye en la calidad de la limpieza intestinal en pacientes no seleccionados. Sin embargo, no hay datos en el subgrupo de pacientes con factores de riesgo de una limpieza intestinal insuficiente. Objetivo: El objetivo de este estudio fue evaluar si una DBR de 3 días mejoraba o no la calidad de la limpieza intestinal en pacientes con factores de riesgo de limpieza intestinal deficiente. Pacientes y métodos: Análisis post-hoc de un ensayo controlado aleatorizado realizado entre diciembre de 2017 y marzo de 2018 en un hospital de atención terciaria. Los pacientes con alto riesgo de limpieza intestinal deficiente se seleccionaron mediante una puntuación validada. Los pacientes se aleatorizaron a los grupos de DBR de un día o DBR de 3 días. Todos los pacientes recibieron una dosis dividida de 2l de polietilenglicol más ácido ascórbico. Se realizaron análisis por intención de tratar (IdT) y por protocolo (PP) para el criterio principal de valoración. Resultados: Se incluyeron 135 pacientes (grupo DBR de un día=67, DBR de 3 días=68). No se observaron diferencias significativas en la tasa de calidad de limpieza suficiente entre los grupos en el análisis por IdT (76,1%; IC del 95%: [64,6-84,8] frente al 79,4 7%, IC del 95%: [68,2-87,4]; razón de posibilidades (OR): 1,2; IC del 95%: [0,54-2,73]) o en el análisis PP: (77,3%; IC del 95 %: [65,7-85,8] frente al 80,3%, IC del 95%: [69,0-88,3]; OR: 1,2; IC del 95% [0,52 -2,77]). No se observaron diferencias significativas en el cumplimiento de la dieta o con la solución limpiadora, en la satisfacción o las dificultades con la DBR y en las tasas de detección de pólipos/adenomas. Conclusión: Nuestros resultados sugieren que la DBR de un día no es inferior a la DBR de 3 días en pacientes con factores de riesgo de limpieza intestinal insuficiente.(AU)

A Prospective Comparison of Sulfate Free Polyethylene Glycol versus Sodium Phosphate Solution for Precolonoscopic Bowel Preparation / 대한소화기내시경학회지

BACKGROUND/AIMS: Polyethylene glycol (PEG) solution is commonly used for precolonoscopic preparation because of its safety and effectiveness. Sulfate free PEG (SF-PEG) solution was developed to reduce the salty taste by removing the sodium sulfate. The aim of this study was to compare the efficacy and patient compliance of SF-PEG and sodium phosphate (NaP) solutions for preparing the bowel before colonoscopy. METHODS: From February through April in 2007, 534 patients who underwent colonoscopy were prospectively enrolled. The efficacy of bowel cleansing was assessed by a doctor's questionnaire and the patient's compliance was assessed by a patient's questionnaire. RESULTS: There was no significant difference between the groups for the "stools and fluids" assessment of bowel cleansing (2.07 vs. 2.14, respectively, p=0.149). However, SF-PEG was more effective on the "air bubbles" assessment (1.34 vs. 1.71, respectively, p<0.001) and the overall assessment (0.72 vs. 0.91, respectively, p=0.010) than NaP. The patients preferred SF-PEG rather than NaP for "Taste" (1.34 vs. 2.25, respectively, p=0.148). However, the patients significantly preferred NaP rather than SF-PEG for "Quantity" (2.46 vs. 1.18, respectively, p<0.001). CONCLUSIONS: The SF-PEG solution showed more effectiveness for bowel cleansing as compared to the NaP solution. SF-PEG tastes better than NaP, but patients are still required to consume 4 liters for the standard preparing regimen.