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Influence of the Retrocolic Versus Antecolic Route for Alimentary Tract Reconstruction on Delayed Gastric Emptying After Pancreatoduodenectomy: A Multicenter, Noninferiority Randomized Controlled Trial.
Toyama, H, Matsumoto, I, Mizumoto, T, Fujita, H, Tsuchida, S, Kanbara, Y, Kadowaki, Y, Maeda, H, Okano, K, Fukuoka, M, et al
Annals of surgery. 2021;(6):935-944
Abstract
OBJECTIVE This study aimed to determine whether retrocolic alimentary tract reconstruction is noninferior to antecolic reconstruction in terms of DGE incidence after pancreatoduodenectomy (PD) and investigated patients' postoperative nutritional status. SUMMARY OF BACKGROUND DATA The influence of the route of alimentary tract reconstruction on DGE after PD is controversial. METHODS Patients from 9 participating institutions scheduled for PD were randomly allocated to the retrocolic or antecolic reconstruction groups. The primary outcome was incidence of DGE, defined according to the 2007 version of the International Study Group for Pancreatic Surgery definition. Noninferiority would be indicated if the incidence of DGE in the retrocolic group did not exceed that in the antecolic group by a margin of 10%. Patients' postoperative nutrition data were compared as secondary outcomes. RESULTS Total, 109 and 103 patients were allocated to the retrocolic and antecolic reconstruction group, respectively (n = 212). Baseline characteristics were similar between both groups. DGE occurred in 17 (15.6%) and 13 (12.6%) patients in the retrocolic and antecolic group, respectively (risk difference; 2.97%, 95% confidence interval; -6.3% to 12.6%, which exceeded the specified margin of 10%). There were no differences in the incidence of other postoperative complications and in the duration of hospitalization. Postoperative nutritional indices were similar between both groups. CONCLUSIONS This trial could not demonstrate the noninferiority of retrocolic to antecolic alimentary tract reconstruction in terms of DGE incidence. The alimentary tract should not be reconstructed via the retrocolic route after PD, to prevent DGE.
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Development and Validation of Test for "Leaky Gut" Small Intestinal and Colonic Permeability Using Sugars in Healthy Adults.
Khoshbin, K, Khanna, L, Maselli, D, Atieh, J, Breen-Lyles, M, Arndt, K, Rhoten, D, Dyer, RB, Singh, RJ, Nayar, S, et al
Gastroenterology. 2021;(2):463-475.e13
Abstract
BACKGROUND Oral monosaccharides and disaccharides are used to measure in vivo human gut permeability through urinary excretion. AIMS The aims were as follows: (1) to obtain normative data on small intestinal and colonic permeability; (2) to assess variance on standard 16 g fiber diet performed twice; (3) to determine whether dietary fiber influences gut permeability measurements; and (4) to present pilot data using 2 selected probes in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). METHODS Sixty healthy female and male adults, age 18-70 years, participated in 3 randomized studies (2 studies on 16.25 g and 1 study on 32.5 g fiber) in otherwise standardized diets. At each test, the following sugars were ingested: 12C-mannitol, 13C-mannitol, rhamnose (monosaccharides), sucralose, and lactulose (disaccharides). Standardized meals were administered from 24 hours before and during 24 hours post-sugars with 3 urine collections: 0-2, 2-8, and 8-24 hours. Sugars were measured using high-performance liquid chromatography-tandem mass spectrometry. Eighteen patients with IBS-D underwent 24-hour excretion studies after oral 13C-mannitol and lactulose. RESULTS Baseline sugars (>3-fold above lower limits of quantitation) were identified in the 3 studies: 12C-mannitol in all participants; sucralose in 4-8, and rhamnose in 1-3. Median excretions/24 h (percentage of administered dose) for 13C-mannitol, rhamnose, lactulose, and sucralose were ∼30%, ∼15%, 0.32%, and 2.3%, respectively. 13C-mannitol and rhamnose reflected mainly small intestinal permeability. Intraindividual saccharide excretions were consistent, with minor differences with 16.25 g vs 32.5 g fiber diets. Median interindividual coefficient of variation was 76.5% (10-90 percentile: 34.6-111.0). There were no significant effects of sex, age, or body mass index on permeability measurements in health. 13C-mannitol measurements are feasible in IBS-D. CONCLUSIONS Baseline 12C-mannitol excretion precludes its use; 13C-mannitol is the preferred probe for small intestinal permeability.
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A Randomized Trial Comparing the Bowel Cleansing Efficacy of Sodium Picosulfate/Magnesium Citrate and Polyethylene Glycol/Bisacodyl (The Bowklean Study).
Hung, SY, Chen, HC, Chen, WT
Scientific reports. 2020;(1):5604
Abstract
Bowel cleansing is essential for a successful colonoscopy, but the ideal clearing agent and the volume have yet to be determined. A small-volume cleanser is important for patient compliance. This study aimed to compare the bowel cleansing efficacy, safety, tolerability, and acceptability of a 300-mL small-volume sodium picosulfate/magnesium citrate (PSMC) preparation-Bowklean with one 2-L polyethylene glycol (PEG)/bisacodyl-Klean-Prep/Dulcolax preparation under identical dietary recommendations. This multicenter, randomized, parallel-group, pre-specified noninferiority study enrolled 631 outpatients scheduled to undergo colonoscopy (Bowklean = 316 and Klean-Prep/Dulcolax = 315). After bowel preparation, an independent evaluator blinded to the subject's treatment allocation rated the quality of the colon cleansing. Efficacy was evaluated using the Aronchick Scale and Ottawa Bowel Preparation Scale (OPBS). Safety was assessed by monitoring adverse events. Tolerability and acceptability were measured via a patient questionnaire. Bowklean was non-interior to Klean-Prep/Dulcolax in overall colon cleansing but was associated with significantly better preparation quality. Notably, Bowklean was associated with significantly greater tolerability and acceptability of bowel preparations than Klean-Prep/Dulcolax. Safety profiles did not differ significantly between the groups. Our data indicate that Bowklean is a more effective and better-tolerated bowel cleansing preparation before colonoscopy than Klean-Prep/Dulcolax. Bowklean may therefore increase positive attitudes toward colonoscopies and participation rates.
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The effectiveness of preoperative colon cleansing on post-operative surgical site infection after hip hemiarthroplasty.
Batibay, SG, Soylemez, S, Türkmen, İ, Bayram, Y, Camur, S
European journal of trauma and emergency surgery : official publication of the European Trauma Society. 2020;(5):1071-1076
Abstract
AIM: This study aimed to evaluate the effectiveness of prophylactic mechanical bowel preparation in elderly patients undergoing hip hemiarthroplasty in a single training institution over a period of 2 years. PATIENTS AND METHODS The study was conducted in a prospective-randomised manner. All patients, who underwent primary hip hemiarthroplasty for femoral neck fracture in our institution between 20 February 2015 and 29 December 2016, were included. B.T. Enema (sodium dihydrogen phosphate + disodium hydrogen phosphate) 135 ml (Yenisehir Laboratory, Ankara, Turkey) was used for colon cleansing. RESULTS Ninety-five patients were followed up for at least 1 year after surgery (16.3 ± 4.2 months). Of these, 46 were in the enema group and 49 were in the control group. Demographic and clinical characteristics of patients were similar in both groups (p > 0.05). Infection rates between the two groups were not significantly different (p > 0.05). In addition, ASA, age, sex, presence of diabetes mellitus, duration of surgery, time to surgery, ambulation status and blood count did not have a significant effect on surgical site infections (p > 0.05). However, all infections in the enema group were monobacterial and were successfully treated, whereas two of the four infections in the control group were polymicrobial and could not be successfully treated. CONCLUSION Although preoperative colon cleansing did not reduce the overall incidence of post-operative infections, our study suggested that it may reduce polymicrobial infections after hip hemiarthroplasty. Polymicrobial infections after hip hemiarthroplasty seem to have worse prognosis. Therefore, the effectiveness of preoperative colon cleansing in remediating such infections must be investigated in a larger number of patients.
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Contrasting effects of viscous and particulate fibers on colonic fermentation in vitro and in vivo, and their impact on intestinal water studied by MRI in a randomized trial.
Gunn, D, Murthy, R, Major, G, Wilkinson-Smith, V, Hoad, C, Marciani, L, Remes-Troche, J, Gill, S, Rossi, M, Harris, H, et al
The American journal of clinical nutrition. 2020;(3):595-602
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Abstract
BACKGROUND Wheat bran, nopal, and psyllium are examples of particulate, viscous and particulate, and viscous fibers, respectively, with laxative properties yet contrasting fermentability. OBJECTIVES We assessed the fermentability of these fibers in vitro and their effects on intestinal function relevant to laxation in vivo using MRI. METHODS Each fiber was predigested prior to measuring gas production in vitro during 48-h anaerobic incubation with healthy fecal samples. We performed a randomized, 3-way crossover trial in 14 healthy volunteers who ingested 7.5 g fiber twice on the day prior to study initiation and once with the study test meal. Serial MRI scans obtained after fasting and hourly for 4 h following meal ingestion were used to assess small bowel water content (SBWC), colonic volumes, and T1 of the ascending colon (T1AC) as measures of colonic water. Breath samples for hydrogen analysis were obtained while patients were in the fasted state and every 30 min for 4 h following meal ingestion. RESULTS In vitro, the onset of gas production was significantly delayed with psyllium (mean ± SD: 14 ± 5 h) compared with wheat bran (6 ± 2 h, P = 0.003) and was associated with a smaller total gas volume (P = 0.01). Prefeeding all 3 fibers for 24 h was associated with an increased fasting T1AC (>75% of values >90th centile of the normal range). There was a further rise during the 4 h after psyllium (0.3 ± 0.3 s P = 0.009), a fall with wheat bran (-0.2 ± 0.2 s; P = 0.02), but no change with nopal (0.0 ± 0.1 s, P = 0.2). SBWC increased for all fibers; nopal stimulated more water than wheat bran [AUC mean (95% CI) difference: 7.1 (0.6, 13.8) L/min, P = 0.03].Breath hydrogen rose significantly after wheat bran and nopal but not after psyllium (P < 0.0001). CONCLUSION Both viscous and particulate fibers are equally effective at increasing colonic T1 over a period of 24 h. Mechanisms include water trapping in the small bowel by viscous fibers and delivery of substrates to the colonic microbiota by more fermentable particulate fiber. This trial was registered at clinicaltrials.gov as NCT03263065.
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Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials.
Gillis, C, Fenton, TR, Sajobi, TT, Minnella, EM, Awasthi, R, Loiselle, SÈ, Liberman, AS, Stein, B, Charlebois, P, Carli, F
Clinical nutrition (Edinburgh, Scotland). 2019;(3):1053-1060
Abstract
BACKGROUND & AIMS Preservation of lean body mass is an important cancer care objective. The capacity for prehabilitation interventions to modulate the lean body mass (LBM) of colorectal cancer patients before and after surgery is unknown. METHODS A pooled analysis of two randomized controlled trials of trimodal prehabilitation vs. trimodal rehabilitation at a single university-affiliated tertiary center employing Enhanced Recovery After Surgery (ERAS) care was conducted. The prehabilitation interventions included exercise, nutrition, and anxiety-reduction elements that began approximately four weeks before surgery and continued for eight weeks after surgery. The rehabilitation interventions were identical to the prehabilitation interventions but were initiated only after surgery. Body composition, measured using multifrequency bioelectrical impedance analysis, was recorded at baseline, pre-surgery, 4 and 8 weeks after surgery. The primary outcome was change in LBM before and after colorectal surgery for cancer. A mixed effects regression model was used to estimate changes in body mass and body composition over time controlling for age, sex, baseline body mass index (BMI), baseline six-minute walk test (6MWT), and postoperative compliance to the interventions. NCT02586701 &NCT01356264. RESULTS Pooled data included 76 patients who followed prehabilitation and 63 patients who followed rehabilitation (n = 139). Neither group experienced changes in preoperative LBM. Compared to rehabilitated patients, prehabilitated patients had significantly more absolute and relative LBM at four and eight-weeks post-surgery in models controlling for age, sex, baseline BMI, baseline 6MWT, and compliance to the postoperative intervention. CONCLUSION Trimodal prehabilitation attenuated the post-surgical LBM loss compared to the loss observed in patients who received the rehabilitation intervention. Patients who receive neither intervention (i.e., standard of care) would be likely to lose more LBM. Offering a prehabilitation program to colorectal cancer patients awaiting resection is a useful strategy to mitigate the impact of the surgical stress response on lean tissue in an ERAS setting, and, in turn, might have a positive impact on the cancer care course. CLINICAL TRIAL REGISTRATION NCT02586701 &NCT01356264 (clinicaltrials.gov).
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In vitro and human pharmacoscintigraphic evaluation of an oral 5-ASA delivery system for colonic release.
Foppoli, A, Maroni, A, Moutaharrik, S, Melocchi, A, Zema, L, Palugan, L, Cerea, M, Gazzaniga, A
International journal of pharmaceutics. 2019;:118723
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5-aminosalicylic acid (5-ASA) is the most widely used drug for the treatment of ulcerative colitis. The benefits of targeted delivery of 5-ASA to the large intestine are well known, resulting in reduced systemic absorption and increased local concentrations at the disease site. In the present study, a 5-ASA colon delivery system based on the time-dependent strategy, exploiting the relatively consistent small intestinal transit time (SITT), was manufactured and evaluated in vitro as well as in vivo. The system was obtained by successive spray-coating of an immediate-release tablet core with low-viscosity HPMC and Eudragit® L. The enteric film was effective in preventing release during the acidic stage of the in vitro test, while the HPMC coating brought about reproducible lag phases prior to release in phosphate buffer medium. A γ-scintigraphy investigation pointed out that, following administration to fasted and fed volunteers, disintegration of the units never occurred prior to colon arrival. In all cases, a lag time preceded the appearance of the drug and its N-acetyl metabolite in the bloodstream, which was found to correlate with the time of disintegration in a linear mode. The plasma levels of the drug and metabolite as well as their cumulative urinary recovery were relatively low with respect to those reported when 5-ASA is delivered to the small bowel.
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Flavanol Bioavailability in Two Cocoa Products with Different Phenolic Content. A Comparative Study in Humans.
Gómez-Juaristi, M, Sarria, B, Martínez-López, S, Bravo Clemente, L, Mateos, R
Nutrients. 2019;(7)
Abstract
Cocoa has beneficial health effects partly due to its high flavanol content. This study was aimed at assessing the absorption and metabolism of polyphenols in two soluble cocoa products: a conventional (CC) and a flavanol-rich product (CC-PP). A crossover, randomized, blind study was performed in 13 healthy men and women. On two different days, after an overnight fast, volunteers consumed one serving of CC (15 g) or CC-PP (25 g) in 200 mL of semi-skimmed milk containing 19.80 mg and 68.25 mg of flavanols, respectively. Blood and urine samples were taken, before and after CC and CC-PP consumption, and analyzed by high-performance liquid chromatography coupled to electrospray ionisation and quadrupole time-of-flight mass spectrometry (HPLC-ESI-QToF-MS). Up to 10 and 30 metabolites were identified in plasma and urine, respectively. Phase II derivatives of epicatechin were identified with kinetics compatible with small intestine absorption, although the most abundant groups of metabolites were phase II derivatives of phenyl-γ-valerolactone and phenylvaleric acid, formed at colonic level. 5-(4'-Hydroxyphenyl)-γ-valerolactone-sulfate could be a sensitive biomarker of cocoa flavanol intake. CC and CC-PP flavanols showed a dose-dependent absorption with a recovery of 35%. In conclusion, cocoa flavanols are moderately bioavailable and extensively metabolized, mainly by the colonic microbiota.
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Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution.
Repici, A, Coron, E, Sharma, P, Spada, C, Di Leo, M, Noble, CL, Gschossmann, J, Bargalló García, A, Baumgart, DC
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2019;(12):1671-1677
Abstract
BACKGROUND & AIMS Colonoscopy requires bowel cleansing for gut mucosa visualization; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of two randomized trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists. METHODS Patients received NER1006, 2L PEG + ascorbate (2LPEG), or oral sulfate solution (OSS) as a 2-day evening/morning regimen (N2D) or NER1006 morning-only dosing (N1D). Treatment-blinded site endoscopists assessed cleansing using the Harefield Cleansing Scale (HCS). Analyses were conducted in a modified full analysis set, including (mFAS; n = 1378) or excluding (mFAS2; n = 1319) imputed failures, and in patients with 100% treatment adherence (mFAS100; n = 1047). Overall cleansing success (HCS grade A/B), overall high-quality cleansing (HCS grade A), and high-quality segments (HCS 3-4) per treatment population were analyzed. RESULTS Overall cleansing success was higher with N2D than 2LPEG (92.7-97.5% vs. 87.9-93.0%), and more patients had overall high-quality cleansing with N2D and N1D than 2LPEG (68.0-72.1% and 64.0-68.4% vs. 50.7-56.0%). Without imputed failures, N2D delivered more overall high-quality cleansing than OSS (74.5-77.3% vs. 67.8-69.8%). More high-quality segments were demonstrated with N2D and N1D versus 2 LPEG (82.5-87.1% and 79.4-84.4% vs. 70.4-76.3%) and with N2D versus OSS (82.7-89.5% vs. 78.1-84.4%). CONCLUSION When assessed by site endoscopists, NER1006 delivers greater high-quality cleansing than 2LPEG or OSS.
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Low-FODMAP vs regular rye bread in irritable bowel syndrome: Randomized SmartPill® study.
Pirkola, L, Laatikainen, R, Loponen, J, Hongisto, SM, Hillilä, M, Nuora, A, Yang, B, Linderborg, KM, Freese, R
World journal of gastroenterology. 2018;(11):1259-1268
Abstract
AIM: To compare the effects of regular vs low-FODMAP rye bread on irritable bowel syndrome (IBS) symptoms and to study gastrointestinal conditions with SmartPill®. METHODS Our aim was to evaluate if rye bread low in FODMAPs would cause reduced hydrogen excretion, lower intraluminal pressure, higher colonic pH, different transit times, and fewer IBS symptoms than regular rye bread. The study was a randomized, double-blind, controlled cross-over meal study. Female IBS patients (n = 7) ate study breads at three consecutive meals during one day. The diet was similar for both study periods except for the FODMAP content of the bread consumed during the study day. Intraluminal pH, transit time, and pressure were measured by SmartPill, an indigestible motility capsule. RESULTS Hydrogen excretion (a marker of colonic fermentation) expressed as area under the curve (AUC)(0-630 min) was [median (range)] 6300 (1785-10800) ppm∙min for low-FODMAP rye bread and 10 635 (4215-13080) ppm∙min for regular bread (P = 0.028). Mean scores of gastrointestinal symptoms showed no statistically significant differences but suggested less flatulence after low-FODMAP bread consumption (P = 0.063). Intraluminal pressure correlated significantly with total symptom score after regular rye bread (ρ = 0.786, P = 0.036) and nearly significantly after low-FODMAP bread consumption (ρ = 0.75, P = 0.052). We found no differences in pH, pressure, or transit times between the breads. Gastric residence of SmartPill was slower than expected. SmartPill left the stomach in less than 5 h only during one measurement (out of 14 measurements in total) and therefore did not follow on par with the rye bread bolus. CONCLUSION Low-FODMAP rye bread reduced colonic fermentation vs regular rye bread. No difference was found in median values of intraluminal conditions of the gastrointestinal tract.