Randomized Pilot Study: Anal Inserts Versus Percutaneous Tibial Nerve Stimulation in Patients With Fecal Incontinence.

BACKGROUND: Anal inserts and percutaneous tibial nerve stimulation may be offered to those with fecal incontinence in whom other conservative treatments have failed. OBJECTIVE: We aimed to compare anal inserts and percutaneous tibial nerve stimulation. DESIGN: This was an investigator-blinded randomized pilot study. SETTINGS: The study was conducted at a large tertiary care hospital. PATIENTS: Adult patients with passive or mixed fecal incontinence were recruited. INTERVENTIONS: Patients were randomly assigned to receive either the anal inserts or weekly percutaneous tibial nerve stimulation for a period of 3 months. MAIN OUTCOME MEASURES: The primary end point was a 50% reduction of episodes of fecal incontinence per week as calculated by a prospectively completed 2-week bowel diary. Secondary end points were St Mark's incontinence score, International Consultation on Incontinence Questionnaire-Bowel scores (for bowel pattern, bowel control, and quality of life), use of antidiarrheal agents, estimates of comfort and acceptability. RESULTS: Fifty patients were recruited: 25 were randomly assigned to anal inserts and 25 were randomly assigned to percutaneous tibial nerve stimulation. All completed treatment. A significant improvement of scores in the 2-week bowel diary, the St Mark's scores and the International Consultation on Incontinence Questionnaire-Bowel scores, was seen in both groups after 3 months of treatment. A reduction of ≥50% fecal incontinence episodes was reached by 76% (n = 19/25) by the anal insert group, compared with 48% (n = 12/25) of those in the percutaneous tibial nerve stimulation group (p = 0.04). The St Mark's fecal incontinence scores and the International Consultation on Incontinence Questionnaire-Bowel scores for bowel pattern, bowel control, and quality of life (p = 0.01) suggest similar improvement for each group. LIMITATIONS: A realistic sample size calculation could not be performed because of the paucity of objective prospective studies assessing the effect of the insert device and percutaneous tibial nerve stimulation. CONCLUSIONS: Both anal insert and percutaneous tibial nerve stimulation improved the symptoms of fecal incontinence after 3 months of treatment. The insert device appeared to be more effective than percutaneous tibial nerve stimulation. Larger studies are needed to investigate this further. See Video Abstract at http://links.lww.com/DCR/B460. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov No. NCT04273009. ESTUDIO PILOTO ALEATORIZADO DE INSERCIONES ANALES CONTRA LA ESTIMULACIN PERCUTNEA DEL NERVIO TIBIAL EN PACIENTES CON INCONTINENCIA FECAL: ANTECEDENTES:Las inserciones anales y la estimulación percutánea del nervio tibial (PTNS) se pueden ofrecer a las personas con incontinencia fecal que han fallado en otros tratamientos conservadores.OBJETIVO:Nuestro objetivo fue comparar inserciones anales y estimulación percutánea del nervio tibial.DISEÑO:Este fue un estudio piloto aleatorio ciego para investigadores.AJUSTE:El estudio se realizó en un hospital de atención terciaria.PACIENTES:Se reclutaron pacientes adultos con incontinencia fecal pasiva o mixta.INTERVENCIONES:Los pacientes fueron asignados al azar para recibir inserciones anales o estimulación del nervio tibial percutáneo semanal durante un período de tres meses.PRINCIPALES MEDIDAS DE RESULTADO:El principal resultado fue una reducción del 50% de los episodios de incontinencia fecal por semana, según lo calculado mediante un diario intestinal de dos semanas completado de forma prospectiva. Los criterios de valoración secundarios fueron la puntuación de incontinencia de St Mark, las puntuaciones del ICIQ-B (para patrón intestinal, control intestinal y calidad de vida), uso de agentes antidiarreicos, estimaciones de comodidad y aceptabilidad.RESULTADOS:Se reclutaron 50 pacientes: 25 fueron asignados al azar a inserciones anales y 25 a PTNS. Todo el tratamiento completado. Se observó una mejora significativa de las puntuaciones en el diario intestinal de dos semanas, la puntuación de St Mark y la puntuación del ICIQ-B en ambos grupos después de 3 meses de tratamiento. Se alcanzó una reducción de ≥ 50% de los episodios de incontinencia fecal en un 76% (n = 19/25) en el grupo de inserción anal, en comparación con el 48% (n = 12/25) de los del grupo de estimulación percutánea del nervio tibial (p = 0,04). Las puntuaciones de incontinencia fecal de St Mark, las puntuaciones del ICIQ-B para el patrón intestinal, el control intestinal y la calidad de vida (p = 0,01) sugieren una mejora similar para cada grupo.LIMITACIONES:No se pudo realizar un cálculo realista del tamaño de la muestra debido a la escasez de estudios prospectivos objetivos que evaluaran el efecto del dispositivo de inserción y la estimulación percutánea del nervio tibial.CONCLUSIONES:Tanto la inserción anal como la estimulación percutánea del nervio tibial mejoraron los síntomas de incontinencia fecal después de 3 meses de tratamiento. El dispositivo de inserción parecia ser más efectivo que la estimulación percutánea del nervio tibial. Se necesitan estudios más amplios para investigar esto más a fondo. Consulte Video Resumen en http://links.lww.com/DCR/B460.NÚMERO DE REGISTRO DE PRUEBA:Clinicaltrials.gov No. NCT04273009.

A simple clinical decision rule to rule out appendicitis in patients with nondiagnostic ultrasound results.

OBJECTIVES: The objective was to identify a set of clinical features that can rule out appendicitis in patients with suspected acute appendicitis and nondiagnostic ultrasound (US) results, allowing safe discharge and next-day reevaluation without initial computed tomography (CT) or magnetic resonance imaging (MRI). METHODS: Data on clinical and US evaluation, including a number of prespecified variables potentially associated with acute appendicitis, were prospectively collected in two diagnostic accuracy studies of imaging. These studies included patients with suspected appendicitis seen in the emergency department (ED). For development and validation of the clinical decision rule (CDR), only patients with inconclusive or negative US results were included. There were 199 (of 422) patients in the development cohorts and 120 (of 211) patients in the validation cohort. Logistic regression analysis was used for data from patients with inconclusive or negative US results, and profiles were created of all possible combinations of predictors retained in the multivariable model. A final diagnosis was assigned by an expert panel based on perioperative data, histopathology, and clinical follow-up of at least 3 months. RESULTS: The CDR selected patients after negative or inconclusive US for discharge and next-day reevaluation without initial CT or MRI if fewer than two of the following predictors were present: male sex, migration of pain to the right lower quadrant, vomiting, and white blood cell (WBC) count higher than 12.0 × 10(9) /L. Applying the CDR in the development set selected 126 of 199 (63%) patients with negative or inconclusive US results for discharge without further imaging. This rule reduced the probability of appendicitis from 26% (51 of 199) in the total group of patients with negative or inconclusive US results to 12% (15 of 126) in the group that would be discharged based on the rule (p = 0.001). In the validation set (n = 120), the decision rule selected 72 (60%) patients for discharge and next-day reevaluation and reduced the probability of appendicitis from 20% (24 of 120) in the total group to 6% (4 of 72) in the patients selected on the rule (p = 0.001). The negative predictive value of the decision rule in the validation set was 94% (95% confidence interval [CI] = 87% to 98%). In comparison, the negative predictive value of CT in the same group was 99% (95% CI = 93% to 100%, p = 0.14), and that of MRI was 99% (95% CI = 94% to 100%, p = 0.12). Alternative decision rules based on combinations of the present decision rule with C-reactive protein (CRP) results did not improve selection. CONCLUSIONS: This newly developed CDR significantly reduces the probability of appendicitis in a large subgroup of patients with negative or inconclusive US results. These patients can be safely discharged for outpatient reevaluation without further initial imaging if proper follow-up is available. This could assist in lowering the number of ED imaging investigations in patients with suspected appendicitis.

Diagnostic accuracy and patient acceptance of MRI in children with suspected appendicitis.

OBJECTIVE: To compare magnetic resonance imaging (MRI) and ultrasound in children with suspected appendicitis. METHODS: In a single-centre diagnostic accuracy study, children with suspected appendicitis were prospectively identified at the emergency department. All underwent abdominal ultrasound and MRI within 2 h, with the reader blinded to other imaging findings. An expert panel established the final diagnosis after 3 months. We evaluated the diagnostic accuracy of three imaging strategies: ultrasound only, conditional MRI after negative or inconclusive ultrasound, and MRI only. Significance between sensitivity and specificity was calculated using McNemar's test statistic. RESULTS: Between April and December 2009 we included 104 consecutive children (47 male, mean age 12). According to the expert panel, 58 patients had appendicitis. The sensitivity of MRI only and conditional MRI was 100% (95% confidence interval 92-100), that of ultrasound was significantly lower (76%; 63-85, P < 0.001). Specificity was comparable among the three investigated strategies; ultrasound only 89% (77-95), conditional MRI 80% (67-89), MRI only 89% (77-95) (P values 0.13, 0.13 and 1.00). CONCLUSION: In children with suspected appendicitis, strategies with MRI (MRI only, conditional MRI) had a higher sensitivity for appendicitis compared with a strategy with ultrasound only, while specificity was comparable. KEY POINTS: • In children, MRI has a higher sensitivity for appendicitis than ultrasound. • Ultrasound followed by MRI in negative or inconclusive findings is accurate. • The tolerance for ultrasound and MRI in children is comparable. • MRI can be performed in children in an emergency setting.

Accuracy and interobserver agreement between MR-non-expert radiologists and MR-experts in reading MRI for suspected appendicitis.

OBJECTIVE: To compare accuracy and interobserver agreement between radiologists with limited experience in the evaluation of abdominal MRI (non-experts), and radiologists with longer MR reading experience (experts), in reading MRI in patients with suspected appendicitis. METHODS: MR imaging was performed in 223 adult patients with suspected appendicitis and read independently by two members of a team of eight MR-inexperienced radiologists, who were trained with 100 MR examinations previous to this study (non-expert reading). Expert reading was performed by two radiologists with a larger abdominal MR experience (>500 examinations) in consensus. A final diagnosis was assigned after three months based on all available information, except MRI findings. We estimated MRI sensitivity and specificity for appendicitis and for all urgent diagnoses separately. Interobserver agreement was evaluated using kappa statistics. RESULTS: Urgent diagnoses were assigned to 147 of 223 patients; 117 had appendicitis. Sensitivity for appendicitis was 0.89 by MR-non-expert radiologists and 0.97 in MR-expert reading (p=0.01). Specificity was 0.83 for MR-non-experts versus 0.93 for MR-expert reading (p=0.002). MR-experts and MR-non-experts agreed on appendicitis in 89% of cases (kappa 0.78). Accuracy in detecting urgent diagnoses was significantly lower in MR-non-experts compared to MR-expert reading: sensitivity 0.84 versus 0.95 (p<0.001) and specificity 0.71 versus 0.82 (p=0.03), respectively. Agreement on urgent diagnoses was 83% (kappa 0.63). CONCLUSION: MR-non-experts have sufficient sensitivity in reading MRI in patients with suspected appendicitis, with good agreement with MR-expert reading, but accuracy of MR-expert reading was higher.

MRI features associated with acute appendicitis.

OBJECTIVES: To identify MRI features associated with appendicitis. METHODS: Features expected to be associated with appendicitis were recorded in consensus by two expert radiologists on 223 abdominal MRIs in patients with suspected appendicitis. Nine MRI features were studied: appendix diameter >7 mm, appendicolith, peri-appendiceal fat infiltration, peri-appendiceal fluid, absence of gas in the appendix, appendiceal wall destruction, restricted diffusion of the appendiceal wall, lumen or focal fluid collections. Appendicitis was assigned as the final diagnosis in 117/223 patients. Associations between imaging features and appendicitis were evaluated with logistic regression analysis. RESULTS: All investigated features were significantly associated with appendicitis in univariate analysis. Combinations of two and three features were associated with a probability of appendicitis of 88 % and 92 %, respectively. In patients without any of the nine features, appendicitis was present in 2 % of cases. After multivariate analysis, only an appendix diameter >7 mm, peri-appendiceal fat infiltration and restricted diffusion of the appendiceal wall were significantly associated with appendicitis. The probability of appendicitis was 96 % in their presence and 2 % in their absence. CONCLUSIONS: An appendix diameter >7 mm, peri-appendiceal fat infiltration and restricted diffusion of the appendiceal wall have the strongest association with appendicitis on MRI. KEY POINTS: • An enlarged appendix, fat infiltration and restricted diffusion are associated with appendicitis. • One such feature on MRI gives an 88 % probability of appendicitis. • Two features in combination give a probability of appendicitis of 94 %. • Combinations of three features give a probability of appendicitis of 96 %. • The absence of these features almost rules out appendicitis (2 %).

Comparison of imaging strategies with conditional contrast-enhanced CT and unenhanced MR imaging in patients suspected of having appendicitis: a multicenter diagnostic performance study.

PURPOSE: To compare the diagnostic performance of imaging strategies with magnetic resonance (MR) imaging and computed tomographic (CT) imaging in adult patients suspected of having appendicitis. MATERIALS AND METHODS: Institutional review board approval was obtained prior to study initiation, and patients gave written informed consent. In a multicenter diagnostic performance study, adults suspected of having appendicitis were prospectively identified in the emergency department. Consenting patients underwent ultrasonography (US) and subsequent contrast-enhanced CT if US imaging yielded negative or inconclusive results. Additionally, all patients underwent unenhanced MR imaging, with the reader blinded to other findings. An expert panel assigned final diagnosis after 3 months. Diagnostic performance of three imaging strategies was evaluated: conditional CT after US, conditional MR imaging after US, and immediate MR imaging. Sensitivity and specificity were calculated by comparing findings with final diagnosis. RESULTS: Between March and September 2010, 229 US, 115 CT, and 223 MR examinations were performed in 230 patients (median age, 35 years; 40% men). Appendicitis was the final diagnosis in 118 cases. Conditional and immediate MR imaging had sensitivity and specificity comparable to that of conditional CT, which resulted in 3% (three of 118; 95% confidence interval [CI]: 1%, 7%) missed appendicitis, and 8% (10 of 125; 95% CI: 4%, 14%) false-positives. Conditional MR missed appendicitis in 2% (two of 118; 95% CI: 0%, 6%) and generated 10% (13 of 129; 95% CI: 6%, 16%) false-positives. Immediate MR missed 3% (four of 117; 95% CI: 1%, 8%) appendicitis with 6% (seven of 120; 95% CI: 3%, 12%) false-positives. Conditional strategies resulted in more false-positives in women than in men (conditional CT, 17% vs 0%; P = .03; conditional MR, 19% vs 1%; P = .04), wherease immediate MR imaging did not. CONCLUSION: The accuracy of conditional or immediate MR imaging was similar to that of conditional CT in patients suspected of having appendicitis, which implied that strategies with MR imaging may replace conditional CT for appendicitis detection.

A systematic review and meta-analysis of diagnostic performance of imaging in acute cholecystitis.

PURPOSE: To update previously summarized estimates of diagnostic accuracy for acute cholecystitis and to obtain summary estimates for more recently introduced modalities. MATERIALS AND METHODS: A systematic search was performed in MEDLINE, EMBASE, Cochrane Library, and CINAHL databases up to March 2011 to identify studies about evaluation of imaging modalities in patients who were suspected of having acute cholecystitis. Inclusion criteria were explicit criteria for a positive test result, surgery and/or follow-up as the reference standard, and sufficient data to construct a 2 × 2 table. Studies about evaluation of predominantly acalculous cholecystitis in intensive care unit patients were excluded. Bivariate random-effects modeling was used to obtain summary estimates of sensitivity and specificity. RESULTS: Fifty-seven studies were included, with evaluation of 5859 patients. Sensitivity of cholescintigraphy (96%; 95% confidence interval [CI]: 94%, 97%) was significantly higher than sensitivity of ultrasonography (US) (81%; 95% CI: 75%, 87%) and magnetic resonance (MR) imaging (85%; 95% CI: 66%, 95%). There were no significant differences in specificity among cholescintigraphy (90%; 95% CI: 86%, 93%), US (83%; 95% CI: 74%, 89%) and MR imaging (81%; 95% CI: 69%, 90%). Only one study about evaluation of computed tomography (CT) met the inclusion criteria; the reported sensitivity was 94% (95% CI: 73%, 99%) at a specificity of 59% (95% CI: 42%, 74%). CONCLUSION: Cholescintigraphy has the highest diagnostic accuracy of all imaging modalities in detection of acute cholecystitis. The diagnostic accuracy of US has a substantial margin of error, comparable to that of MR imaging, while CT is still underevaluated.

Acute appendicitis on abdominal MR images: training readers to improve diagnostic accuracy.

PURPOSE: To determine if training with direct feedback helps to improve the diagnostic performance of inexperienced readers in the detection of appendicitis on magnetic resonance (MR) images. MATERIALS AND METHODS: The institutional review board approved this retrospective study and waived the requirement for informed consent. Nine radiologists and eight residents without experience in evaluating MR images for acute abdominal conditions evaluated a training set of images from 100 MR imaging examinations of patients suspected of having appendicitis and received direct feedback after each evaluation. An expert panel made a diagnosis of appendicitis in 45 patients and an alternative diagnosis in 55 patients on the basis of histopathologic examination and follow-up. Readers recorded two diagnoses: the first after viewing images from conventional MR sequences (half-Fourier rapid acquisition with relaxation enhancement and true fast imaging with steady-state precession) and the second after viewing diffusion-weighted (DW) MR images. Reader sensitivity and specificity were calculated per set of 25 cases. RESULTS: The average reader sensitivity for detecting appendicitis improved significantly after training (0.82 vs 0.92, P = .003); the average specificity improved nonsignificantly (0.82 vs 0.88, P = .10). Sensitivity for radiologists increased from 0.81 in the first set of 25 cases to 0.91 in the last set, and specificity improved from 0.82 to 0.85. For residents, sensitivity increased from 0.82 to 0.94, and specificity increased from 0.82 to 0.91. Sensitivity improved from 0.80 to 0.87 (P < .001) in all readings combined when DW images were read in addition to conventional MR images. CONCLUSION: Diagnostic accuracy of inexperienced readers in the evaluation of abdominal MR images for acute appendicitis improved after training with direct feedback, and the addition of DW images improved reader sensitivity.

Streptococcus milleri in intraabdominal abscesses in children after appendectomy: incidence and course.

INTRODUCTION: Intraabdominal abscesses are a common complication after appendectomy, especially in children. In this study, we describe the incidence and course of this complication in relation to the cultured pathogens found in intraabdominal abscesses. METHODS: The charts of all patients between 1 and 18 years of age undergoing appendectomy in 3 hospitals between January 2006, and July 2009, were retrospectively reviewed. Presence of an intraabdominal abscess was confirmed with abdominal ultrasound examination. We collected all details concerning the appendectomy, pus cultures, and postoperative course in these patients. RESULTS: Two hundred fifty-nine patients underwent appendectomy during the study period. Subsequently, abdominal ultrasound studies showed an intraabdominal abscess in 18 (7%) patients. Intraabdominal abscesses developed more frequently after perforated appendicitis (23%) than after simple appendicitis (2%). The incidence of postoperative abscesses did not differ significantly between open (5.6%) or laparoscopic (6.3%) appendectomy. However, the rate was high (38%) in the patients in whom the appendectomy was converted from laparoscopic to open. In 15 out of the 18 patients with a postoperative abscess drainage was performed. In pus cultures of the drained abscesses Streptococcus milleri and Escherichia coli were the most commonly isolated pathogens. Presence of S milleri was associated with prolonged hospital stay (13.9 versus 9.0 days, P = .105) and prolonged antibiotic treatment (11.3 versus 4.8 days, P = .203). CONCLUSIONS: The incidence of intraabdominal abscesses is high after perforated appendicitis in children (23%). Our data suggest that the presence of S milleri correlates with a more complicated postoperative course after appendectomy in children.

Optimizing imaging in suspected appendicitis (OPTIMAP-study): a multicenter diagnostic accuracy study of MRI in patients with suspected acute appendicitis. Study Protocol.

BACKGROUND: In patients with clinically suspected appendicitis, imaging is needed to substantiate the clinical diagnosis. Imaging accuracy of ultrasonography (US) is suboptimal, while the most accurate technique (CT) is associated with cancer related deaths through exposure to ionizing radiation. MRI is a potential replacement, without associated ionizing radiation and no need for contrast medium administration. If MRI is proven to be sufficiently accurate, it could be introduced in the diagnostic pathway of patients with suspected appendicitis, increasing diagnostic accuracy and improving clinical outcomes, without the risk of radiation induced cancer or iodinated contrast medium-related drawbacks. The multicenter OPTIMAP study was designed to estimate the diagnostic accuracy of MRI in patients with suspected acute appendicitis in the general population. METHODS/DESIGN: Eligible for this study are consecutive patients presenting with clinically suspected appendicitis at the emergency department in six centers. All patients will undergo imaging according to the Dutch guideline for acute appendicitis: initial ultrasonography in all and subsequent CT whenever US does not confirm acute appendicitis. Then MRI is performed in all patients, but the results are not used for patient management. A final diagnosis assigned by an expert panel, based on all available information including 3-months follow-up, except MRI findings, is used as the reference standard in estimating accuracy. We will calculate the sensitivity, specificity, predictive values and inter-observer agreement of MRI, and aim to include 230 patients. Patient acceptance and total imaging costs will also be evaluated. DISCUSSION: If MRI is found to be sufficiently accurate, it could replace CT in some or all patients. This will limit or obviate the ionizing radiation exposure associated risk of cancer induction and contrast medium induced nephropathy with CT, preventing the burden and the direct and indirect costs associated with treatment. Based on the high intrinsic contrast resolution of MRI, one might envision higher accuracy rates for MRI than for CT. If so, MRI could further decrease the number of unnecessary appendectomies and the number of missed appendicitis cases. TRIAL REGISTRATION: NTR2148.

[Fewer unnecessary appendectomies following ultrasonography and CT]. / Minder onterechte appendectomie door echografie en CT.

OBJECTIVE: To evaluate the effect of the use of ultrasonography (US) and optional computed tomography (CT) or diagnostic laparoscopy on the percentage of unnecessary appendectomies in patients with suspected acute appendicitis. DESIGN: Prospective and comparison with a historical control group. METHOD: Following the introduction of ultrasound imaging as an initial step, the outcomes in all patients presenting with suspected appendicitis in the emergency department were prospectively collected during a period of 18 months (July 2006-December 2007). Results were compared to retrospectively collected data on all patients who had undergone appendectomy for acute appendicitis in 2001, before the introduction of this imaging investigation. RESULTS: Of the 312 consecutive patients in the emergency department with suspected acute appendicitis, the condition was excluded in 51 patients following clinical and laboratory investigation. The diagnostic algorithm was applied in 239 of the 261 patients (92%). All of them had initial US, followed by additional CT in 75 patients (31%) and diagnostic laparoscopy in 12 patients (5%). Appendectomy was performed in 130 patients, and 8 (6%) of the appendices were shown to be healthy following pathological investigation. Before the implementation of preoperative imaging 36 of the 170 appendices (21%) were healthy. Following the introduction of imaging techniques in accordance with the guideline there was a significant reduction in the percentage of unnecessary appendectomies (21% versus 6%; p < 0,001). The complete supplementary diagnostic algorithm had a positive and negative predictive value of respectively 90% and 98% for acute appendicitis. CONCLUSION: Structural implementation of US with optional CT and diagnostic laparoscopy in patients with suspected acute appendicitis resulted in a lower percentage of unnecessary appendectomies.