An Open-Label, Noncomparative, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx Gel as a Bulking Agent for the Treatment of Fecal Incontinence

Fecal incontinence (FI) is the involuntary loss of rectal contents through the anal canal. Reports of its prevalence vary from 1–21%. Studies, have demonstrated a positive effect on FI symptoms with injectable bulking agents. This study evaluated the safety and efficacy of NASHA/Dx gel in the treatment of FI. One hundred fifteen eligible patients suffering from FI received 4 injections of 1 mL NASHA/Dx gel. Primary efficacy was based on data from 86 patients that completed the study. This study demonstrated a ≥50% reduction from baseline in the number of FI episodes in 57.1% of patients at 6 months, and 64.0% at 12 months. Significant improvements (P < .001) were also noted in total number of both solid and loose FI episodes, FI free days, CCFIS, and FIQL scores in all 4 domains. The majority of the treatment related AEs (94.9%) were mild or moderate intensity, and (98.7%) of AEs resolved spontaneously, or following treatment, without sequelae. Results of this study indicate NASHA/Dx gel was efficacious in the treatment of FI. Treatment effect was significant both in reduction of number of FI episodes and disease specific quality of life at 6 months and lasted up to 12 months after treatment

Peristomal Skin Complications Are Common, Expensive, and Difficult to Manage: A Population Based Cost Modeling Study

BACKGROUND: Peristomal skin complications (PSCs) are the most common post-operative complications following creation of a stoma. Living with a stoma is a challenge, not only for the patient and their carers, but also for society as a whole. Due to methodological problems of PSC assessment, the associated health-economic burden of medium to longterm complications has been poorly described. AIM: The aim of the present study was to create a model to estimate treatment costs of PSCs using the standardized assessment Ostomy Skin Tool as a reference. The resultant model was applied to a real-life global data set of stoma patients (n = 3017) to determine the prevalence and financial burden of PSCs. METHODS: Eleven experienced stoma care nurses were interviewed to get a global understanding of a treatment algorithm that formed the basis of the cost analysis. The estimated costs were based on a seven week treatment period. PSC costs were estimated for five underlying diagnostic categories and three levels of severity. The estimated treatment costs of severe cases of PSCs were increased 2-5 fold for the different diagnostic categories of PSCs compared with mild cases. French unit costs were applied to the global data set. RESULTS: The estimated total average cost for a seven week treatment period (including appliances and accessories) was 263€ for those with PSCs (n = 1742) compared to 215€ for those without PSCs (n = 1172). A co-variance analysis showed that leakage level had a significant impact on PSC cost from 'rarely/never' to 'always/often' p<0.00001 and from 'rarely/never' to 'sometimes' p = 0.0115. CONCLUSION: PSCs are common and troublesome and the consequences are substantial, both for the patient and from a health economic viewpoint. PSCs should be diagnosed and treated at an early stage to prevent long term, debilitating and expensive complications

Traitement des sinus pilonidaux sacro-coccygiens chroniques (revue de la littérature et recherche de facteurs de risque de récidive sur une étude rétrospective de 71 cas)

Introduction : Le sinus pilonidal sacro-coccygien (SPSC) est une pathologie invalidante malgré de nombreux traitements chirurgicaux possibles. Le but de notre étude était de rechercher des facteurs de risque de récidive, puis de confronter les résultats aux données de la littérature sur le traitement du SPSC. Méthodes : Nous avons inclus 71 interventions via nos données PMSI entre 2008 et 2011. Les caractéristiques et les données des patients ont été recueillies dans les dossiers et par téléphone. Résultats : Les résultats retrouvent en analyse univariée, une augmentation significative du risque de récidive chez les patients : avec un BMI > 30 ou ayant déjà eu une exérèse de SPSC. Les résultats en analyse multivariée ne retrouvent pas de différence significative. Seul l'obésité est à la limite de la significativité avec un p = 0.0586. Conclusion : Les patients dont le BMI est supérieur à 30 ou récidivant devraient préférentiellement avoir une chirurgie de type plastie dont les résultats dans la littérature semblent meilleurs sans être significatifs dans les méta-analyses.NANTES-BU Médecine pharmacie (441092101) / SudocSudocFranceF

Syndrome de l'ulcère solitaire du rectum (résultats fonctionnels et qualité de vie à partir d'une étude multicentrique de 41 malades)

Introduction : Le syndrome de l'ulcère solitaire du rectum est une affection bénigne de la paroi du rectum associée à un trouble de la statique rectale et à un trouble du comportement à la défécation. Il n'existe pas de consensus concernant la prise en charge thérapeutique, partagée entre les traitements laxatifs, la rééducation et la chirurgie. L'objectif de cette étude était d'évaluer le résultat fonctionnel et la qualité de vie des patients pris en charge pour ce problème. Patients et méthodes : L'étude, bicentrique (Nantes et Rennes), a répertorié les patients adressés pour un SUSR sans prolapsus extériorisé du rectum. Un questionnaire comportant un score de qualité de vie (GIQLI), de constipation et d'incontinence a été adressé aux patients par courrier. Résultats : 41 patients ont été inclus entre 1991 et 2002. La population était homogène et présentait des performances sphinctériennes satisfaisantes. La dyschésie dominait le tableau clinique (95) avec les rectorragies. Vingt-deux patients ont suivi un traitement par laxatifs (exclusif dans 7 cas), 16 patients ont suivi une rééducation, 24 patients ont été opérés (19 rectopexies, 5 voies périnéales), 7 patients ont été opérés plusieurs fois. Deux patients sont porteurs d'une stomie à l'issue de l'étude. Le GIQLI à 43 mois de suivi est de 89/144. Le score de constipation KESS est de 19/38. Le score d'incontinence de Jorge et Wexner est de 5,3/20. Le GIQLI est significativement inférieur à celui d'une population témoin. Le type de traitement n'influence pas la qualité de vie. Il existe une corrélation linéaire entre résultat fonctionnel et qualité de vie. Le délai diagnostique, le traitement médical, la contraction paradoxale du muscle puborectal, le périnée descendant et la procidence atteignant le canal anal sont des paramètres influençant la qualité de vie. Conclusion : Le traitement du SUSR n'offre pas au patient un résultat satisfaisant en terme de qualité de vie. La constipation et l'incontinence sont des paramètres déterminant la qualité de vie. L'existence d'un trouble de la statique rectale et d'un anisme, conditionnent les résultats de la prise en charge, de même que le retard diagnostique.NANTES-BU Médecine pharmacie (441092101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Le ganglion sentinelle dans le cancer colorectal (évaluation prospective d'une méthode de détection radio-isotopique et colorimétrique )

Introduction : Chaque année en France, plus de 33 000 patients sont traités pour un adénocarcinome lieberkühnien colorectal. Parmi les patients sans envahissement ganglionnaire après résection chirurgicale à visée curative, un tiers va récidiver. But de l'étude : nous avons cherché à évaluer l'intérêt de la recherche du ganglion sentinelle (GS) par une double technique radio-isotopique et colorimétrique, afin de mettre en évidence des micrométastases en immunohistochimie (IHC). Patients : 57 patients ont été inclus, de avril 2004 à mars 2005,et évalués dans 2 centres investigateurs, dans le cadre d'un programme hospitalier de recherche clinique. Résultats : Le taux de détection du GS a été de 91%. Le taux de faux-négatif (GS négatif avec envahissement d'un ganglion non-sentinelle) a été de 48%. Une patiente présentait un trajet de drainage aberrant et deux patients avaient des micrométastases ganglionnaires. Dans ces 3 cas l'attitude thérapeutique a été modifiée par la recherche du GS. Conclusion : Cette méthode, grâce à un meilleur staging ganglionnaire, permet de sélectionner une population de pN0 à haut risque de récidive. Ce groupe est celui qui pourrait, potentiellement , bénéficier d'une chimiothérapie adjuvante. L'association des 2 méthodes de repérage demande une coordination entre les différentes équipes médico-chirurgicales et entraîne un surcoût, mais n'augmente pas statistiquement le taux de détection du GS, sauf chez les patients obèses.NANTES-BU Médecine pharmacie (441092101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Long-term Experience of Magnetic Anal Sphincter Augmentation in Patients With Fecal Incontinence.

BACKGROUND: Magnetic anal sphincter augmentation is a novel technique for the treatment of patients with fecal incontinence. OBJECTIVE: The current study reports the long-term effectiveness and safety of this new treatment modality. DESIGN: This was a prospective multicenter pilot study. SETTINGS: The study was performed at 4 clinical sites in Europe and the United States. PATIENTS: The cohort included patients with severe fecal incontinence for ≥6 months who had previously failed conservative therapy and were implanted with a magnetic anal sphincter device between 2008 and 2011. MAIN OUTCOME MEASURES: Adverse events, symptom severity, quality of life, and bowel diary data were collected. RESULTS: A total of 35 patients (34 women) underwent magnetic anal sphincter augmentation. The median length of follow-up was 5.0 years (range, 0-5.6 years), with 23 patients completing assessment at 5 years. Eight patients underwent a subsequent operation (7 device explantations) because of device failure or complications, 7 of which occurred in the first year. Therapeutic success rates, with patients who underwent device explantation or stoma creation counted as treatment failures, were 63% at year 1, 66% at year 3 and 53% at year 5. In patients who retained their device, the number of incontinent episodes per week and Cleveland Clinic incontinence scores significantly decreased from baseline, and there were significant improvements in all 4 scales of the Fecal Incontinence Quality of Life instrument. There were 30 adverse events reported in 20 patients, most commonly defecatory dysfunction (20%), pain (14%), erosion (11%), and infection (11%). LIMITATIONS: This study does not allow for comparison between surgical treatments and involves a limited number of patients. CONCLUSIONS: Magnetic anal sphincter augmentation provided excellent outcomes in patients who retained a functioning device at long-term follow-up. Protocols to reduce early complications will be important to improve overall results

Cost of PSC according to diagnostic categories (DS).

<p>*Other: Was assigned an imputed cost equal to the weighted average cost for a patient with known cause of PSC with the same level of severity. PSC: Peristomal Skin Complication. DS: Dialogue Study.</p

Sacral Nerve Stimulation for Fecal Incontinence

International audienceBACKGROUND:Decision-making for pulse generator implantation for sacral nerve stimulation in the management of fecal incontinence is based on the results of a test phase. Its duration is still a matter of debate.OBJECTIVE:The purpose of this study was to determine whether an early positive response during the test phase could predict implantation of a permanent sacral nerve pulse generator.DESIGN:This was a short-term observational cohort study. A positive response was defined as a >50% decrease of fecal leaks compared with baseline. A multivariate logistic regression was computed to predict pulse generator implantation after the first week of the test phase.SETTINGS:The study was conducted in 3 national referral centers.PATIENTS:From January 2006 to December 2012, 144 patients with fecal incontinence enrolled in a prospectively maintained database completed a 2- to 3-week bowel diary, at baseline and during test phase.MAIN OUTCOME MEASURES:The primary outcome was the clinical decision to implant a pulse generator. The primary predictor was a calculated score including the number of leak episodes, bowel movements, and urgencies and the time to defer defecation expressed in minutes during the first screening test week.RESULTS:After the first, second and third week of the test phase, 81 (56%) of 144, 96 (67%) of 144, and 93 (70%) of 131 patients had a positive test. A permanent pulse generator was implanted in 114. Time to defer defecation increased during the 3 weeks of screening. Urgencies were unchanged. The computed score was predictive of a permanent pulse generator implantation (Se = 72.6% (95% CI, 59.8-83.1); Sp = 100% (95% CI, 78.2-100); c-index = 0.86 (95% CI, 0.78-0.94)).LIMITATIONS:No cost analysis or projection based on our proposal to reduce the test phase has been made.CONCLUSIONS:Permanent pulse generator implantation can be safely proposed early (1-week screening) to fast responders. Nonetheless, permanent implantation may be decided as well in patients exhibiting a delayed response. Whether a rapid response to sacral nerve stimulation could be predictive of a long-term response remains to be determined. See Video Abstract at http://links.lww.com/DCR/A452