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Diseases of the Colon and Rectum Mar 2024The p value has been criticized as an oversimplified determination of whether a treatment effect exists. One alternative is the fragility index. It is a representation...
BACKGROUND
The p value has been criticized as an oversimplified determination of whether a treatment effect exists. One alternative is the fragility index. It is a representation of the minimum number of nonevents that would need to be converted to events to increase the p value above 0.05.
OBJECTIVE
To determine the fragility index of randomized controlled trials assessing the efficacy of interventions for patients with diverticular disease since 2010 to assess the robustness of current evidence.
DESIGN
MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to August 2022.
SETTINGS
Articles were eligible for inclusion if they were randomized trials conducted between 2010 and 2022 with parallel, superiority designs evaluating interventions in patients with diverticular disease. Only randomized trials with dichotomous primary outcomes with an associated p value of <0.05 were considered for inclusion.
PARTICIPANTS
Any surgical or medical intervention for patients with diverticular disease.
MAIN OUTCOME MEASURES
The fragility index was determined by adding events and subtracting nonevents from the groups with the smaller number of events. Events were added until the p value exceeded 0.05. The smallest number of events required was considered the fragility index.
RESULTS
After screening 1271 citations, 15 randomized trials met the inclusion criteria. Nine of the studies evaluated surgical interventions and 6 evaluated medical interventions. The mean number of patients randomly assigned and lost to follow-up per randomized controlled trial was 92 (SD 35.3) and 9 (SD 11.4), respectively. The median fragility index was 1 (range, 0-5). The fragility indices for the included studies did not correlate significantly with any study characteristics.
LIMITATIONS
Small sample, heterogeneity, and lack of inclusion of studies with continuous outcomes.
CONCLUSIONS
The randomized trials evaluating surgical and medical interventions for diverticular disease are not robust. Changing a single-outcome event in most studies was sufficient to make a statistically significant study finding not significant. See Video Abstract .
FRAGILIDAD DE LOS RESULTADOS ESTADSTICAMENTE SIGNIFICATIVOS EN ENSAYOS ALEATORIOS DE ENFERMEDAD DIVERTICULAR DEL COLON UNA REVISIN SISTEMTICA
ANTECEDENTES:El valor p ha sido criticado por una determinación demasiado simplificada de si existe un efecto del tratamiento. Una alternativa es el Índice de Fragilidad. Es una representación del número mínimo de no eventos que deberían convertirse en eventos para aumentar el valor p por encima de 0,05.OBJETIVO:Determinar el IF de ensayos controlados aleatorios que evalúan la eficacia de las intervenciones para pacientes con enfermedad diverticular desde 2010 para evaluar la solidez de la evidencia actual.FUENTES DE DATOS:Se realizaron búsquedas en MEDLINE, Embase y CENTRAL desde el inicio hasta agosto de 2022.SELECCIÓN DE ESTUDIOS:Los artículos eran elegibles para su inclusión si eran ensayos aleatorizados realizados entre 2010 y 2022 con diseños paralelos de superioridad que evaluaran intervenciones en pacientes con enfermedad diverticular. Sólo se consideraron para su inclusión los ensayos aleatorizados con resultados primarios dicotómicos con un valor de p asociado menor que 0,05.INTERVENCIÓNES:Cualquier intervención quirúrgica o médica para pacientes con enfermedad diverticular.PRINCIPALES MEDIDAS DE VALORACIÓN:El índice de fragilidad se determinó sumando eventos y restando no eventos de los grupos con el menor número de eventos. Se agregaron eventos hasta que el valor p superó 0,05. El menor número de eventos requeridos se consideró índice de fragilidad.RESULTADOS:Después de examinar 1271 citas, 15 ensayos aleatorios cumplieron los criterios de inclusión. Nueve de los estudios evaluaron intervenciones quirúrgicas y seis evaluaron intervenciones médicas. El número medio de pacientes aleatorizados y perdidos durante el seguimiento por ECA fue 92 (DE 35,3) y 9 (DE 11,4), respectivamente. La mediana del índice de fragilidad fue 1 (rango: 0-5). Los índices de fragilidad de los estudios incluidos no se correlacionaron significativamente con ninguna característica del estudio.LIMITACIONES:Muestra pequeña, heterogeneidad y falta de inclusión de estudios con resultados continuos.CONCLUSIONES:Los ensayos aleatorios que evalúan las intervenciones quirúrgicas y médicas para la enfermedad diverticular no son sólidos. Cambiar un solo evento de resultado en la mayoría de los estudios fue suficiente para que un hallazgo estadísticamente significativo del estudio no fuera significativo. (Traducción- Dr. Ingrid Melo ).
Topics: Humans; Randomized Controlled Trials as Topic; Diverticulosis, Colonic; Diverticular Diseases; Diverticulum, Colon; Retrospective Studies
PubMed: 37889999
DOI: 10.1097/DCR.0000000000003014 -
DEN Open Apr 2024The primary therapeutic strategy for the management of bile duct stones (BDS) is endoscopic retrograde cholangiopancreatography. However, there may be a recurrence of... (Review)
Review
BACKGROUND
The primary therapeutic strategy for the management of bile duct stones (BDS) is endoscopic retrograde cholangiopancreatography. However, there may be a recurrence of BDS on follow-up. Multiple risk factors have been studied for the prediction of BDS recurrence. We aimed to analyze the incidence of symptomatic BDS recurrence, systematically review the risk factors, and analyze the most important risk factors among those.
METHODS
A comprehensive search of three databases was conducted from inception to November 2022 for studies reporting the recurrence of BDS recurrence after endoscopic retrograde cholangiopancreatography with clearance, along with an analysis of risk factors.
RESULTS
A total of 37 studies with 12,952 patients were included in the final analysis. The pooled event rate for the recurrence of BDS stones was 12.6% (95% confidence interval: 11.2-13.9). The most important risk factor was a bile duct diameter ≥15 mm, which had a significant association with recurrence in twelve studies. Other risk factors with significant association with recurrence in three or more studies were the reduced angulation of the bile duct, the presence of periampullary diverticulum, type I periampullary diverticulum, in-situ gallbladder with stones, cholecystectomy, multiple stones in the bile duct, use of mechanical lithotripsy, and bile duct stent placement.
CONCLUSION
Around one out of seven patients have BDS recurrence after the initial endoscopic retrograde cholangiopancreatography. Bile duct size and anatomy are the most important predictors of recurrence. The assessment of risk factors associated with recurrence may help keep a close follow-up in high-risk patients.
PubMed: 37818098
DOI: 10.1002/deo2.294 -
International Journal of Colorectal... Sep 2023There is a hypothesis of an association between diverticulosis and metabolic syndrome (MS) or its components, but data on this topic are inconsistent, and a systematic... (Review)
Review
BACKGROUND
There is a hypothesis of an association between diverticulosis and metabolic syndrome (MS) or its components, but data on this topic are inconsistent, and a systematic review has not been performed. We conducted a systematic review to investigate the possible association between cardiometabolic risk factors and diverticulosis.
METHODS
A systematic literature search was conducted via PubMed, Cochrane Library, and Web of Science in December 2022 to collect the necessary data. Studies that examined the association between MS or individual metabolic factors and asymptomatic diverticulosis were included in the review.
RESULTS
Of the potentially relevant articles identified via PubMed (477), Cochrane Library (224), and Web of Science (296), 29 articles met the inclusion criteria and were used for this work. These studies were assessed for study quality using GRADE. Overall, 6 studies were rated as "very low," 19 studies as "low," and 4 studies as "moderate." The data suggest an association between arterial hypertension, obesity, and fatty liver disease in younger patients and diverticulosis. Patient age appears to play an important role in diverticular formation. Data on diabetes mellitus is inconclusive and may require further investigation depending on the location of the diverticula.
CONCLUSION
Based on the synthesized data, there is an association between arterial hypertension, obesity, and fatty liver disease in younger patients. The formation of diverticula seems to be influenced by age and genetic factors. The study suggests a connection with cardiometabolic risk factors. To gain a better understanding of the role of metabolic risk factors in asymptomatic diverticulosis, targeted studies are necessary based on these findings.
Topics: Humans; Diverticulum; Hypertension; Obesity; Risk Factors; Liver Diseases
PubMed: 37725283
DOI: 10.1007/s00384-023-04532-4 -
Medicine Sep 2023Capsule endoscopy is the first-line investigation for small bowel disorders. Capsule retention in the small bowel is the most common adverse event. Retention has also...
Capsule endoscopy is the first-line investigation for small bowel disorders. Capsule retention in the small bowel is the most common adverse event. Retention has also been reported in the upper esophagus; however, guidance for diagnosis and management is lacking. This review aims to summarize the diagnostic workup and management of this complication. We conducted a systematic literature review by searching 5 databases; relevant keywords and MeSH terms were used. Exclusion criteria included publications of non-adult patients in non-English languages. Data from eligible studies were analyzed using IBM SPSS 29. Twelve case reports were found (9 males, median age of 76 years); 10 capsule retentions in Zenker's diverticulum and 2 in the cricopharyngeus. Most patients were asymptomatic before capsule endoscopy. Capsule retention was symptomatic in half of the patients (6/12). A neck X-ray confirmed the diagnosis in all patients. Endoscopic capsule retrieval was achieved by different tools (9/12) (Roth's net was the most used tool, 6 patients); retrieval required rigid endoscopy in a few cases (3/12). Endoscopic capsule re-insertion was successful; using an overtube to bypass the upper esophagus was the safest method. In conclusion, capsule retention in the upper esophagus is uncommon yet exposes patients to the risk of unnecessary procedures. Symptoms of swallowing and medium-to-large size Zenker's diverticulum should be considered contra-indications for capsule endoscopy. Neck and chest X-rays are required for elderly patients who do not pass the capsule 2 weeks after ingestion. Endoscopic retrieval using Roth's net and re-insertion through an overtube should be considered first-line management.
Topics: Aged; Male; Humans; Capsule Endoscopy; Zenker Diverticulum; Esophageal Sphincter, Upper; Databases, Factual; Deglutition
PubMed: 37682178
DOI: 10.1097/MD.0000000000035113 -
Cureus Aug 2023Zenker's diverticulum treatment options range from endoscopic rigid or flexible procedures to surgery. There are limited studies available comparing these techniques.... (Review)
Review
Zenker's diverticulum treatment options range from endoscopic rigid or flexible procedures to surgery. There are limited studies available comparing these techniques. Frequently, the choice of treatment depends on the physician's preference or experience, as well as the institution's resources and capacity. Therefore, this study aims to define the best approach based on the highest efficacy and the lowest severe adverse events. In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a comprehensive search was performed. Only comparative studies were included, analyzing flexible endoscopy versus rigid endoscopy or surgery. The outcomes analyzed were clinical and technical success, severe adverse events, length of stay, and duration of the procedure. Analysis was performed using Review Manager 5.4.1 (RevMan 5.4, The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark). Eight retrospective cohort studies met the inclusion criteria. A total of 1281 patients were identified, 492 underwent flexible endoscopy, 453 underwent rigid endoscopy, and 336 underwent surgery. There was no difference in clinical success [risk difference (RD), 0.07 (95% CI -0.05 to 0.19%); P = 0.26], technical success [RD, 0.07 (95% CI -0.03 to 0.16); P = 0.18], severe adverse events [RD, -0.03 (95% CI -0.13 to 0.07; P = 0.052), perforation [RD, 0.07 (95% CI -0.04 to 0.19); P = 0.22] or procedure time [mean difference (MD), - 10.03 (95% CI -26.93 to 6.88); P = 0.24). There was lower length of stay with flexible endoscopy compared to the other approaches [MD, -1.98 (95% CI -3.56 to -0.40); P = 0.001]. Based on the current evidence, the three main techniques are effective for the treatment of Zenker's diverticulum. Although there was no significant difference in the safety of each technique in this meta-analysis, this result should be interpreted cautiously due to the limited data and the risk of vies between the techniques, considering that the results tend to favor flexible endoscopy, mainly explained by the newer and safer devices. Length of stay is lower with flexible endoscopy versus the other techniques, which can be beneficial considering the geriatric populations where Zenker's diverticulum mainly occurs.
PubMed: 37680421
DOI: 10.7759/cureus.43021 -
Archives de Pediatrie : Organe Officiel... Oct 2023The health and safety hazards related to button batteries (BB) have been extensively studied, highlighting that the presence of a button battery in the esophagus is a...
BACKGROUND
The health and safety hazards related to button batteries (BB) have been extensively studied, highlighting that the presence of a button battery in the esophagus is a life-threatening emergency. However, complications related to bowel BB are poorly evaluated and not well known. The objective of this review of the literature was to describe severe cases of BB that have passed the pylorus.
CASE REPORT
This case, from the PilBouTox cohort, is the first report of small-bowel occlusion following ingestion of an LR44 BB (diameter: 11.4 mm) by a 7-month-old infant with a history of intestinal resections. In this case, the BB was ingested without a witness. The initial presentation mimicked acute gastroenteritis evolving into hypovolemic shock. An X-ray revealed a foreign body stuck in the small bowel causing an intestinal occlusion and local necrosis without perforation. The patient's history of intestinal stenosis and intestinal surgery were the contributing factor of impaction.
SYSTEMATIC LITERATURE REVIEW
The review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. The research was conducted on September 12, 2022 through five database and the U.S. Poison Control Center website. An additional 12 severe cases of intestinal or colonic injury after ingestion of a single BB were identified. Of these, 11 were related to small BBs (< 15 mm) that impacted Meckel's diverticulum and one was related to postoperative stenosis.
CONCLUSION
In view of the findings, the indications for digestive endoscopy for extraction of a BB in the stomach should include a history of intestinal stenosis or intestinal surgery so as to avoid delayed intestinal perforation or occlusion and prolonged hospitalization.
Topics: Infant; Humans; Pylorus; Constriction, Pathologic; Esophagus; Foreign Bodies; Intestinal Obstruction; Eating
PubMed: 37394366
DOI: 10.1016/j.arcped.2023.05.007 -
Jornal de Pediatria 2023Meckel diverticulum (MD) is a common malformation of the digestive tract, often accompanied by serious complications. It is important to find safe and effective... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Meckel diverticulum (MD) is a common malformation of the digestive tract, often accompanied by serious complications. It is important to find safe and effective diagnostic methods for screening MD. The aim of this study was to evaluate the effectiveness of a technetium-99m (Tc-99m) scan for pediatric bleeding MD.
METHODS
The authors conducted a systematic review of studies published in PubMed, Embase, and Web of Science before 1 January 2023. Studies based on PICOS were included in this systematic review. The flow chart was made by PRISMA software. The quality of included studies was assessed by RevMan5 software (QUADAS-2: Quality Assessment of Diagnostic Accuracy Studies-2). The sensitivity, specificity, and other measurements of accuracy were pooled using Stata/SE 12.0 software.
RESULTS
Sixteen studies with 1115 children were included in this systematic review. A randomized-effects model was used for the meta-analysis because of significant heterogeneity. The combined sensitivity and specificity were 0.80 [Confidence Interval (95% CI, 0.73-0.86) and 0.95 (95% CI, 0.86-0.98)], respectively. The area under the curve (AUC) was 0.88 (95% CI, 0.85-0.90). Publication bias (Begg's test p = 0.053) was observed.
CONCLUSION
Tc-99m scan has high specificity, but moderate sensitivity, which is always influenced by some factors. Hence, the Tc-99m scan has some limitations in the diagnosis of pediatric bleeding MD.
Topics: Child; Humans; Technetium; Meckel Diverticulum; Radionuclide Imaging; Gastrointestinal Hemorrhage; Sensitivity and Specificity
PubMed: 37277097
DOI: 10.1016/j.jped.2023.03.009 -
Journal of Pediatric Surgery Sep 2023Vascular rings may cause tracheal and/or oesophageal compression. For many patients, symptoms/signs have been present for a long period before diagnosis. However, in the... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Vascular rings may cause tracheal and/or oesophageal compression. For many patients, symptoms/signs have been present for a long period before diagnosis. However, in the era of prenatal diagnosis, some units advocate universal early surgery. The risks and efficacy of surgery must be known to adequately counsel for the operation. This meta-analysis sought to define the morbidity and mortality associated with surgical correction, and persistent post-operative symptoms.
METHODS
PubMed, Cochrane Library and CINAHL databases were searched for studies that described the outcome of patients undergoing surgery for a double or right aortic arch (DAA or RAA). Non-comparative and random effects model-based meta-analyses were conducted to calculate the pooled rates of mortality, surgical complications, reintervention, and persistent follow-up symptoms.
RESULTS
Nineteen eligible studies were included comprising 18 studies describing outcomes for DAA surgery and 15 for RAA surgery. For DAA surgery, overall mortality rate was 0% [95% confidence interval (CI) 0.0-1.0], post-surgical complication rate 18% [95% CI: 12.0-23.0], prevalence of reintervention 3% [95% CI: 1.0-5.0] and prevalence of symptoms at last follow-up was 33% [95% CI: 17.0-52.0]. For RAA surgery, overall pooled mortality was 0% [95% CI: 0.0-0.0], prevalence of post-surgical complications was 15% [95% CI: 8.0-23.0], reintervention rate was 2% [95% CI: 0.0-4.0], prevalence of symptoms at last follow-up was 40% [95% CI: 26.0-55.0].
CONCLUSIONS
While surgery to correct a vascular ring is safe, the rate of persistent symptoms is high and further strategies must be sought to reduce this burden.
Topics: Pregnancy; Female; Humans; Vascular Ring; Aorta, Thoracic; Prenatal Diagnosis; Trachea; Subclavian Artery
PubMed: 36967253
DOI: 10.1016/j.jpedsurg.2023.02.058