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Objectives: To compare the efficacy and safety of sedation with midazolam and remimazolam for colorectal endoscopy. Methods: This single-center, two-arm, post-hoc analysis of the REM-IICTJP01 study investigated the efficacy and safety of remimazolam for gastrointestinal endoscopic sedation. We enrolled 40 and 208 patients who underwent colonoscopy under remimazolam and midazolam sedation, respectively, during the same period. The primary outcome was the time from the end of the colonoscopy until discharge. The secondary outcomes included the time from the end of the colonoscopy until awakening, dosage, and adverse events. Propensity score matching was employed to eliminate the effect of confounding factors. Results: Thirty-seven patients in each group were matched. After propensity matching, the time to awakening after colonoscopy was 28.0 (13.0-37.0) min in the midazolam group and 0 (0-0) min in the remimazolam group; moreover, the time till discharge was 40.0 (35.0-46.5) min in the midazolam group and 0 (0-5.0) min in the remimazolam group, both of which were significantly shorter in the remimazolam group (p < 0.01). The number of additional doses was 0 (0-0) and 2 (1-3) in the midazolam and remimazolam groups, respectively. The total dose was 2.0 (2.0-3.5) and 6.0 (5.0-7.0) mg in the midazolam and remimazolam groups, respectively. Conclusions: Remimazolam yielded significantly faster times to awakening and discharge safely compared to midazolam.
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The renal glomerulus produces primary urine from blood plasma by ultrafiltration. The ultrastructure of the glomerulus is closely related to filtration function and disease development. The ultrastructure of the glomeruli has mainly been evaluated using transmission electron microscopy. However, the volume that can be observed using transmission electron microscopy is extremely limited relative to the total volume of the glomerulus. Consequently, observing structures that exist in only one location in each glomerulus, such as the vascular pole, and evaluating low-density or localized lesions are challenging tasks. Array tomography (AT) is a technique used to analyze the ultrastructure of tissues and cells via scanning electron microscopy of serial sections. In this study, we propose an AT workflow optimized for observing complete serial sections of the whole glomerulus, shared several analytical examples using the optimized AT workflow, and demonstrate the usefulness of this approach. Overall, this AT workflow can be a powerful tool for structural and pathological evaluation of the glomerulus. This workflow is also expected to provide new insights into the ultrastructure of the glomerulus and its constituent cells.
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INTRODUCTION: We conducted an investigator-initiated clinical trial in which remimazolam was used to achieve sedation in patients undergoing colonoscopy. METHODS: This multicenter, double-blind, placebo-controlled, phase III investigator-initiated trial included patients who underwent colonoscopy under sedation achieved with remimazolam (initial dose: 3 mg; additional doses: 1 mg) or normal saline (placebo). The primary endpoint was the sedation success rate during colonoscopy, defined as successful sedation (modified observer's alertness/sedation [MOAA/S] score ≤4 prior to colonoscopy), the successful completion of the colonoscopy, and no more than five additional doses of remimazolam per 15 min during the procedure. RESULTS: The sedation success rate was 95.0% (38/40 patients) in the remimazolam group and 0.0% (0/11 patients) in the placebo group (p<0.01). The time from the end of the procedure to awakening was 0.0 (interquartile range: 0.0-0.0) min in both groups. The time from the end of the procedure to ambulation was 5.0 min (interquartile range: 0.0-10.0 min) in the remimazolam group and 0.0 min (interquartile range: 0.0-0.0 min) in the placebo group (p=0.02). No serious adverse events occurred. CONCLUSION: The use of remimazolam to achieve sedation in Japanese patients undergoing colonoscopy was more effective than the use of a placebo. CLINICAL TRIAL REGISTRATION: This study was registered in the Japan Registry of Clinical Trials (registration number: jRCT2031200360).
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Aim: The Mental Health Supporter Training Program is a national project conducted in Japan. This study aimed to determine the effects on mental health-related stigma, mental health literacy, and knowledge about mental health difficulties and support techniques among program participants. Methods: The target population was local residents of a wide range of generations in Japan. Outcomes were assessed at baseline (T1), immediately postintervention (T2), and at the 6-month follow-up (T3). A mixed model for repeated-measures conditional growth model analyses were employed to examine the effects of the intervention over time (T1, T2, T3). We also calculated effect sizes using Cohen's d. Results: The program had a significantly favorable pooled effect on the Japanese version of the Reported and Intended Behaviour Scale score after adjusting for covariates (reported behavior [t = 3.20, p = 0.001]; intended behavior [t = 8.04, p < 0.001]). However, when compared at each time point, only intended behavior from T1 to T2 showed a significant difference (t = 8.37, p < 0.001). Significant pooled effects were found for mental health literacy (knowledge: t = 19.85, p < 0.001; attitude: t = 15.02, p < 0.001), knowledge of mental health (t = 28.04, p < 0.001), and psychological distress (t = -2.41, p = 0.016). Conclusion: The results suggest that the program might be effective for improving intended, but not reported, behavior in the short term and for improving mental health literacy, knowledge of mental health, and psychological distress.
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BACKGROUND: The age of onset of the phyllodes tumor is generally in the late 40 s, and diagnosis and treatment during pregnancy and lactation are rare. We herein present a case of a phyllodes tumor that rapidly increased in size during the pregnancy and lactation period. CASE PRESENTATION: A 39-year-old woman was referred to our hospital with a mass in the right breast that increased in size during the pregnancy and lactation period. On ultrasound (5 week postpartum), a well-defined lobulated mass with internal septations and fluid retention was observed. Magnetic resonance imaging of the breast at 8 week postpartum revealed a 70-mm-sized smooth-margin mass with multilocular cystic components. Marked proliferation of stromal cells with high cell density was observed in a biopsy specimen taken at the previous hospital. We diagnosed the mass as a phyllodes tumor of borderline malignancy and excised it at 13 week postpartum. The excised tumor was 85 mm in diameter and its interior was filled with a milk-like substance. Histologically, there was only a mild increase in stromal cell density but fibrosis with associated degeneration was prominent. The final diagnosis was benign phyllodes tumor with degeneration. CONCLUSIONS: We report a case of a phyllodes tumor that rapidly increased in size during pregnancy and the lactation period. The accumulation of a milk-like substance was thought to be responsible for the rapid growth of the tumor.
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Primary angiitis of central nervous system (PACNS) is a rare idiopathic vasculitis that typically involves small arteries. An 18-year-old woman was operated on for resection of a ruptured aneurysm in a cerebral artery. Multiple aneurysms of cerebral arteries had been detected by neuroimaging examinations since the age of 12, and she had been administered drugs following a diagnosis of PACNS since the age of 15. The resected aneurysm was a ruptured saccular aneurysm occurring in a medium-sized artery. Histologically, necrotizing arteritis of the polyarteritis nodosa (PAN) type was noted in the aneurysmal wall. It consisted of an admixture of acute and healing stages. In the acute stage, fibrinoid necrosis in the intima and media and intense inflammatory cell infiltrate in the entire wall were present. The inflammatory cells mainly consisted of lymphocytes, including plasma cells, neutrophils, and macrophages. In the healing stage, disappearance of fibrinoid necrosis, fibrosis in the intima and media, and scarce inflammatory cells were noted. The acute stage was mainly present near the ruptured site. From these findings, the aneurysm was considered to have been caused by necrotizing arteritis of the PAN type. Although saccular aneurysmal formation in a medium-sized artery is rare in PACNS, an understanding of aneurysms produced by necrotizing arteritis of the PAN type offers useful information for the diagnosis and treatment of PACNS.
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OBJECTIVES: To assess the effectiveness of remimazolam against normal saline (placebo) as a sedative agent for endoscopy in a multicenter, randomized, double-blind, investigator-initiated phase III controlled trial. METHODS: We included 48 Japanese patients undergoing upper gastrointestinal endoscopy. For the procedure, an initial remimazolam dose of 3 mg and additional doses of 1 mg were administered, as determined in the phase II clinical study. The primary study end-point was the successful sedation rate during gastrointestinal endoscopy, determined as a Modified Observer's Assessment of Alertness/Sedation score ≤4 before the start of endoscopy, the completion of gastrointestinal endoscopy, and two or fewer additional doses per 6 min. RESULTS: The successful endoscopy sedation rates were 91.9% and 9.1% in the remimazolam and placebo groups, respectively (P < 0.01). The time from the end of endoscopy to arousal was 0.0 (0.0-0.0) min for both groups. The number of additional doses required to achieve sedation was lower in the remimazolam group than that in the placebo group (P < 0.01). CONCLUSIONS: Remimazolam demonstrated a significantly higher sedation effect during upper gastrointestinal endoscopy in Japanese patients with safe and fast recovery compared with placebo.
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Primary gallbladder neuroendocrine tumor (GB-NET) is extremely rare. Therefore, tumor behavior and adequate treatment in GB-NETs are still unclear. A 74-year-old man without any specific complaints was referred to our hospital cause of gallbladder tumor. Abdominal ultrasonography examination revealed a 22-mm non-pedunculated tumor in the gallbladder body. Contrast-enhanced computed tomography showed a polyp that was enhanced in the arterial phase. The patient underwent gallbladder bed resection and radical lymphadenectomy with a diagnosis of gallbladder carcinoma. Macroscopically, the resected specimen showed a nodular expanding tumor measuring 32×15 mm in the gallbladder body. From the pathological findings, a grade 3 GB-NET was diagnosed. Only cystic lymph node metastasis was observed. The patient was discharged uneventfully, but bone and lymph node metastasis were detected eight months after surgery. We conclude that grade 3 GB-NET shows occasionally malignant biological behavior although NET G3 is distinguished from neuroendocrine carcinoma in the current WHO 2019 classification of NET.
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BACKGROUND: In this study, we aimed to identify predictive factors for coronavirus disease 2019 (COVID-19) patients with complicated pneumonia and determine which COVID-19 patients should undergo computed tomography (CT) using classification and regression tree (CART) analysis. METHODS: This retrospective cross-sectional survey was conducted at a university hospital. We recruited patients diagnosed with COVID-19 between January 1 and December 31, 2020. We extracted clinical information (e.g., vital signs, symptoms, laboratory results, and CT findings) from patient records. Factors potentially predicting COVID-19 pneumonia were analyzed using Student's t-test, the chi-square test, and a CART analysis model. RESULTS: Among 221 patients (119 men (53.8%); mean age, 54.59±18.61 years), 160 (72.4%) had pneumonia. The CART analysis revealed that patients were at high risk of pneumonia if they had C-reactive protein (CRP) levels of >1.60 mg/dL (incidence of pneumonia: 95.7%); CRP levels of ≤1.60 mg/dL + age >35.5 years + lactate dehydrogenase (LDH)>225.5 IU/L (incidence of pneumonia: 95.5%); and CRP levels of ≤1.60 mg/dL + age >35.5 years + LDH≤225.5 IU/L + hemoglobin ≤14.65 g/dL (incidence of pneumonia: 69.6%). The area of the curve of the receiver operating characteristic of the model was 0.860 (95% CI: 0.804-0.915), indicating sufficient explanatory power. CONCLUSIONS: The present results are useful for deciding whether to perform CT in COVID-19 patients. High-risk patients such as those mentioned above should undergo CT.
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BACKGROUND: The efficacy of transnasal endoscopy using an ultrathin endoscope has been reported in several studies. However, few studies regarding peroral endoscopy with ultrathin endoscopes with high resolution have been reported. This study investigates the pain alleviation of peroral endoscopy with an ultrathin endoscope. METHODS: Patients with a history of peroral endoscopy using a conventional, normal-diameter scope with no sedation who underwent peroral esophagogastroduodenoscopy (EGD) using a thin scope between April-July 2022 were included in this study. After the procedure, the patients completed a questionnaire evaluating pain during the examination and willingness to repeat the procedure. The physicians were surveyed regarding their level of satisfaction. The primary endpoint was patient satisfaction, which corresponded to the rate of patients who rated the thin endoscope as more comfortable or somewhat more comfortable than the previously-used, conventional endoscope. RESULTS: One hundred and forty-five patients were included in the analyses. Patient satisfaction was achieved in 86.2% (125/145) of patients. The median visual analog scale pain score was 3 (0-7) points in this study, which is significantly lower than the pain score after the previous endoscopy (5 (0-10) points; p < 0.001). In addition, 96% (24/25) of patients who underwent EGD by an expert and 95.8% (115/120) who underwent EGD by a non-expert were willing to repeat endoscopy using the thin scope (p = 0.69). CONCLUSION: Peroral endoscopy using a thin scope reduces patient pain regardless of the endoscopist's experience.
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Endoscópios , Endoscopia Gastrointestinal , Humanos , Estudos Prospectivos , Dor/etiologia , Dor/prevenção & controle , Satisfação do PacienteRESUMO
BACKGROUND: Mixed neuroendocrine carcinoma (NEC) and hepatocellular carcinoma (HCC) is extremely rare, thus radiological features have not been fully clarified. CASE: A male patient (age: 70 years) visited our hospital due to a tumor in the liver. Examination using contrast-enhanced computed tomography (CT) revealed a tumor (diameter: 5.0 cm) in hepatic segment 5, with early enhancement of the peripheral area and slight internal heterogeneous enhancement in the arterial and delayed phases, respectively. F-18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)/CT revealed intratumoral heterogeneity, characterized by increased uptake (standardized uptake value, 12.10) in the corresponding low-density area detected using enhanced CT relative to the surrounding areas of the tumor. On magnetic resonance imaging, diffusion-weighted imaging also showed high intensity in the corresponding low-density area detected using CT. Preoperatively, the patient was diagnosed with HCC and underwent anterior sectionectomy. Pathological findings revealed both HCC and NEC components, and the patient was diagnosed with mixed NEC and HCC. Comparison of component distribution with FDG-PET/CT revealed an increased uptake area was congruent with the NEC component in the tumor. CONCLUSION: In this case, the difference in tumor components affected the uptake in FDG-PET/CT. Such heterogeneous uptake with an enhanced spot may be useful for suspecting the presence of mixed NEC and HCC in patients with atypical HCC.
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Carcinoma Hepatocelular , Carcinoma Neuroendócrino , Neoplasias Hepáticas , Humanos , Masculino , Idoso , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/cirurgia , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Fluordesoxiglucose F18 , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/cirurgia , Compostos Radiofarmacêuticos , Carcinoma Neuroendócrino/diagnóstico por imagem , Carcinoma Neuroendócrino/cirurgiaRESUMO
Intraosseous lipoma (IOL) is a benign bone tumor that usually arises from the lower limb and rarely arises from the skull. Radiological diagnosis of a typical case is not problematic due to its characteristic calcification and marginal sclerosis. Here, we report a case of calvarial IOL in the early stage lacking conventional radiopathological features. The patient is a 7-year-old girl who presented with a slow-growing protuberance on the vertex of the head. Computed tomography displayed a low-density mass without calcification that was continuous with the surrounding diploe. The mass was resected piece by piece for diagnostic and cosmetic reasons. Histologically, the specimen consisted of bony trabeculae and intertrabecular adipose tissue, which resembled normal fatty marrow. However, adipose tissue was considered neoplastic since it lacked hematopoietic elements. The final diagnosis of IOL was made by radiopathological correlation. This case suggests that IOL should be included in the differential diagnosis of diploic expansion, even if calcification is absent. The histology of an early-stage IOL resembles normal fatty marrow, but recognizing the absence of hematopoietic elements aids the diagnosis. Also, our literature review indicates that such cases are likely to be encountered in the calvaria than cranial base.
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OBJECTIVES: Remimazolam, an ultra-short-acting benzodiazepine, has been used for procedural sedation in the United States. We conducted an investigator-initiated clinical trial to determine the appropriate dose of remimazolam required for sedation during gastrointestinal endoscopy in Japanese subjects. METHODS: In this single-center, open-label, uncontrolled, phase II trial, a three-stage cohort investigated the appropriate initial and additional doses of remimazolam required for gastrointestinal endoscopy. This study was designed with advice from the Pharmaceuticals and Medical Devices Agency. The initial and additional doses were 2 mg and 1 mg/dose, 3 mg and 1 mg/dose, and 5 mg and 2 mg/dose in cohorts 1, 2, and 3, respectively. Each cohort included 10 cases of upper gastrointestinal endoscopy and colonoscopy. The primary end-point was the success rate of sedation during gastrointestinal endoscopy. RESULTS: Sedation was successful in all gastrointestinal endoscopies in cohorts 1 and 2. In cohort 1, sedation was achieved in five (25.0%) and 10 (50.0%) participants with the initial dose and total dose (initial dose + additional dose ≤ the initial dose of the next cohort), respectively, before endoscopy. In cohort 2, sedation was achieved in 11 (55.0%) and 18 (90.0%) participants with the initial dose and total dose, respectively, before endoscopy. No patient in either cohort lost consciousness or required flumazenil or manual ventilation. CONCLUSION: Initial and additional doses of 3 mg and 1 mg/dose of remimazolam, respectively, were shown to be effective and safe for sedation during gastrointestinal endoscopy in Japanese patients.
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Benzodiazepinas , Hipnóticos e Sedativos , Humanos , Estados Unidos , Japão , Método Duplo-Cego , ColonoscopiaAssuntos
Anacardium/efeitos adversos , Anafilaxia/etiologia , Banhos/efeitos adversos , Citrus/efeitos adversos , Hipersensibilidade a Noz/etiologia , Nozes/efeitos adversos , Pectinas/efeitos adversos , Anacardium/imunologia , Anafilaxia/diagnóstico , Anafilaxia/imunologia , Criança , Citrus/imunologia , Humanos , Testes Intradérmicos , Masculino , Hipersensibilidade a Noz/diagnóstico , Hipersensibilidade a Noz/imunologia , Nozes/imunologia , Pectinas/imunologiaRESUMO
BACKGROUND: Although cervical cancer is one of the most common malignancies in pregnancy, its management mainly follows the guidelines for nonpregnant disease state. Within the limited time, patients, and healthcare workers must make difficult decisions to either delay treatment until documented fetal maturity or start immediate treatment based on the disease stage. CASE: The patient was a 37-year-old woman: gravida 1, para 0. Her cervical cytology revealed a high-grade squamous intraepithelial lesion at 8 weeks' gestation. Moreover, invasive squamous cell carcinoma was suspected based on the findings of uterine cervix biopsy. Cervical conization was performed at 11 weeks' gestation, confirming a histopathological diagnosis of squamous cell carcinoma, pT1b2. Cervical cytology findings continued to be negative for intraepithelial lesion or malignancy from 2 weeks after conization until 2 weeks before a cesarean section. In addition, we performed abdominal pelvic lymphadenectomy at 16 weeks' gestation to determine whether the patient could continue her pregnancy. No lymph node metastasis or local recurrence was observed. Finally, a cesarean section and modified radical hysterectomy were performed at 35 weeks' gestation. There was no carcinoma invasion or metastasis. A baby girl weighing 2056 g was delivered with 1- and 5-min Apgar scores of 8 and 9, respectively. Five years postoperatively, there was no evidence of cancer recurrence. CONCLUSION: Management of cervical cancer during pregnancy by using a combination strategy of deep conization and pelvic lymphadenectomy could be an effective strategy for carefully and safely assessing risks of recurrence and metastasis.
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Carcinoma de Células Escamosas , Complicações Neoplásicas na Gravidez , Neoplasias do Colo do Útero , Adulto , Carcinoma de Células Escamosas/diagnóstico , Carcinoma de Células Escamosas/cirurgia , Cesárea , Feminino , Humanos , Estadiamento de Neoplasias , Gravidez , Complicações Neoplásicas na Gravidez/diagnóstico , Complicações Neoplásicas na Gravidez/patologia , Complicações Neoplásicas na Gravidez/cirurgia , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/cirurgiaRESUMO
PURPOSE: It is unclear whether high-definition (HD) imaging improves visibility and diagnostic ability in early gastric cancer (EGC) compared with standard-definition (SD) imaging. We aimed to compare the diagnostic performance and visibility scores of HD and SD ultraslim endoscopes in EGC. MATERIALS AND METHODS: We used HD and SD ultraslim endoscopes to obtain 60 images with similar compositions of gastric environments. Of the 60 images, 30 showed EGC (15 images for each modality) and 30 showed no EGC (15 images for each modality). Seventeen endoscopists evaluated the presence and location of the lesions in each image. Diagnostic ability was compared between modalities. The color difference between a lesion and the surrounding mucosa (ΔE) was measured and compared between the modalities. RESULTS: The ability of HD to detect EGC was significantly higher than that of SD (accuracy: 80.8% vs. 71.6%, P=0.017; sensitivity: 94.9% vs. 76.5%, P<0.001; positive predictive value, 76.2% vs. 55.3%, P<0.001; and negative predictive value (NPV), 94.1% vs. 73.5%, P<0.001). The ability of HD to determine the horizontal extent of EGC was significantly higher than that of SD (accuracy: 71.0% vs. 57.8%, P=0.004; sensitivity: 75.3% vs. 49.0%, P<0.001; NPV, 72.9% vs. 55.9%, P<0.001; and area under the curve: 0.891 vs. 0.631, P=0.038). The mean ΔE was significantly higher for HD than for SD (10.3 vs. 5.9, P=0.011). CONCLUSIONS: The HD ultraslim endoscope showed a higher diagnostic performance in EGC than the SD endoscope because it provided good color contrast.
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BACKGROUND: Tumour-infiltrating lymphocyte (TIL)-high breast tumours have a high rate of pathological complete response (pCR) with neoadjuvant chemotherapy. In our routine pathological diagnoses of biopsy specimens from pCR cases, we have observed a high infiltration of plasma cells (PCs). A positive correlation of PCs with favourable patient outcome has recently been reported, but little is known about how PCs contribute to local tumour immunity. METHODS: We retrospectively examined biopsy specimens from 146 patients with invasive breast cancer who received neoadjuvant chemotherapy. CD138+ PC infiltration was assessed by immunohistochemistry. Multiplexed fluorescent immunohistochemistry (mfIHC) with T and B cell markers was also conducted to elucidate the profile of immune cells. RESULTS: Greater PC infiltration was observed in the pCR group (p = 0.028) and this trend was confirmed in another patient cohort. With mfIHC, we observed significantly more CD8+, T-bet+CD4+, and CD8+FOXP3+ T cells, total B cells and PCs in pCR cases. Such cases were also characterised by high expression of both PD-1 and PD-L1 on B cells and PCs. In patients with hormone receptor-negative tumours, high PC infiltration was correlated with significantly longer disease-free survival (p = 0.034). CONCLUSIONS: We found that higher PC infiltration in biopsy specimens before neoadjuvant chemotherapy was associated with pCR. With mfIHC, we also revealed that the local cytotoxic immune response was clearly enhanced in pCR cases, as was the infiltration of B cells including PCs. Moreover, higher PC levels were correlated with favourable outcomes in hormone receptor-negative breast cancer patients.
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Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/imunologia , Linfócitos do Interstício Tumoral/imunologia , Plasmócitos/imunologia , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Intervalo Livre de Doença , Feminino , Humanos , Linfócitos do Interstício Tumoral/metabolismo , Pessoa de Meia-Idade , Terapia Neoadjuvante , Plasmócitos/metabolismo , Estudos Retrospectivos , Sindecana-1/metabolismo , Resultado do Tratamento , Microambiente Tumoral/imunologiaRESUMO
BACKGROUND: Chronic constipation is a significant factor in poor bowel preparation for colonoscopy. Macrogol 4000 plus electrolytes (Movicol, EA Pharma, Tokyo, Japan), containing polyethylene glycol (PEG) and electrolytes, have been used recently to treat patients with constipation. However, prospective studies on the use of macrogol 4000 for bowel cleansing for colonoscopy are lacking. This study aimed to investigate the efficacy and safety of macrogol 4000 in addition to PEG administered in patients with chronic constipation. METHODS: This single-center, single-arm prospective study enrolled patients with chronic constipation who were scheduled to undergo colonoscopy. The primary endpoint was the proportion of good bowel preparation assessed using the Boston bowel preparation scale (BBPS) (6 or more points). The secondary endpoints were the time from when pPEG (MoviPrep, EA Pharma, Tokyo, Japan) was taken until colonoscopy could be started, amount of PEG taken, number of defecations, whether additional PEG doses were taken, and adverse events. Endoscopy-related endpoints included cecal intubation rate, insertion time, observation time, adenoma detection rate (ADR), and polyp detection rate (PDR). The tolerability of PEG and macrogol 4000 was assessed using a questionnaire. RESULTS: Forty patients were included in the analysis. The median BBPS was 7 (range 3-9) and ≥ 6 points in 37 cases (92.5%). The median time until colonoscopy can be started was 210 min (90-360 min), the median volume of PEG taken was 1500 mL (1000-2000 mL), and the median number of defecations was 7 (3-20). No adverse events were observed. Fourteen patients required an additional dose of PEG. Cecal intubation was achieved in all cases, the median insertion time was 6.0 min (range 2.3-22 min), and the median observation time was 8.8 min (range 4.0-16.0 min). The ADR and PDR were 60.0% and 75.0%, respectively. A proportion of patients rated the tolerability of macrogol 4000 and PEG as 95.0% and 50.0%, respectively. CONCLUSIONS: Intake of macrogol 4000 in addition to PEG is effective and safe for colonoscopy in patients with chronic constipation. Clinical trial registration statement This study was registered in the UMIN-CTR database (UMIN-ID000038315).