Impact of an Education Programme on IBD Patients' Skills: Results of a Randomised Controlled Multicentre Study [ECIPE].

BACKGROUND: Better patient knowledge on inflammatory bowel disease [IBD] could improve outcome and quality of life. The aim of this study was to assess if an education programme improves IBD patients' skills as regards their disease. METHODS: The GETAID group conducted a prospective multicentre randomised controlled study. IBD patients were included at diagnosis, or after a significant event in the disease course. Patients were randomised between 'educated' or control groups for 6 months. Education was performed by trained health care professionals. A psycho-pedagogic score [ECIPE] was evaluated by a 'blinded' physician at baseline and after 6 and 12 months [M6 and M12]. The primary endpoint was the increase of ECIPE score at M6 of more than 20%. RESULTS: A total of 263 patients were included in 19 centres (male:40%; median age:30.8; Crohn's disease [CD]:73%). Of these, 133 patients were randomised into the educated group and 130 into the control group. The median relative increase in ECIPE score at M6 was higher in the educated group as compared with the control group (16.7% [0-42.1%] vs 7% [0-18.8%], respectively, p = 0.0008). The primary endpoint was met in 46% vs 24% of the patients in the educated and control groups, respectively [p = 0.0003]. A total of 92 patients met the primary endpoint. In multivariate analysis, predictors of an increase of at least 20% of the ECIPE score were randomisation in the educated group (odds ratio [OR] = 2.59) and no previous surgery [OR = 1.92]. CONCLUSIONS: These findings support the set-up of education programmes in centres involved in the management of IBD patients.

Rectal intussusception: can high resolution three-dimensional ano-rectal manometry compete with conventional defecography?

BACKGROUND: Three-dimensional high-resolution anorectal manometry (3DHRAM), used for exploring anorectal disorders, was recently developed, providing interesting topographic data for the diagnosis of pelvic floor disorders such as excessive perineal descent. The aim of our study was to define a diagnostic strategy based on selected 3DHRAM parameters to identify rectal intussusceptions (RI), considering conventional defecography (CD) as the gold standard. METHODS: All patients referred to our center in the previous 6 months for 3DHRAM to explore fecal incontinence or constipation, and who previously achieved CD, were eligible. 3DHRAM results were obtained for all classical parameters and the presence of a narrow band of high pressure in the anal canal during attempted defecation, which was recently found to be associated with RI in some studies. The sensitivity, specificity, and positive and negative predictive values were calculated for various 3DHRAM criterion in order to propose a diagnostic strategy for RI. KEY RESULTS: Twenty-six patients (66%) presented with RI on CD. On 3DHRAM, according to our diagnostic strategy, the most relevant manometric criterion for the diagnosis of RI was the association of an anterior additional high-pressure area and an excessive perineal descent, with a positive predictive value of 100% [81.5-100], a specificity of 100% [75.3-100] and a sensibility of 69.2% [48.2-85.7]. CONCLUSIONS & INFERENCES: In this study, 3DHRAM was used to diagnose RI, and we confirmed its use in the diagnosis of pelvic floor disorders. Further studies will be necessary to define classifications for these new anatomic data from 3DHRAM.

Efficacy of the endoscopic management of postoperative fistulas of leakages after esophageal surgery for cancer: a retrospective series.

BACKGROUND AND AIMS: Anastomotic leakages are severe and often lethal adverse events of surgery for esophageal cancer. The endoscopic treatment is growing up in such indications. The aim was to evaluate the efficacy and describe the strategy of the endoscopic management of anastomotic leakages/fistulas after esophageal oncologic surgery. METHODS: Single-center retrospective study on 126 patients operated for esophageal carcinomas between 2010 and 2014. Thirty-five patients with postoperative fistulas/leakages (27 %) were endoscopically managed and included. The primary endpoint was the efficacy of the endoscopic treatment. The secondary endpoints were: delays between surgery, diagnosis, endoscopy and recovery; number of procedures; material used; and adverse events rate. Uni- and multivariate analyses were carried out to determine predictive factors of success. RESULTS: There were mostly men, with a median age of 61.7 years ± 8.9 [43-85]. 48.6 % underwent Lewis-Santy surgery and 45.7 % Akiyama's. 71.4 % patients received neo-adjuvant chemo-radiation therapy. The primary and secondary efficacy was 48.6 and 68.6 %, respectively. The delay between surgery and endoscopy was 8.5 days [6.00-18.25]. Eighty-eight percentages of the patients were treated using double-type metallic stents, with removability and migration rates of 100 and 18 %, respectively. In the other cases, we used over-the-scope clips, naso-cystic drain or combined approach. The mean number of endoscopy was 2.6 ± 1.57 [1-10]. The mortality rate was 17 %, none being related to procedures. No predictive factor of efficacy could be identified. CONCLUSIONS: The endoscopic management of leakages or fistulas after esophageal surgery reached an efficacy rate of 68.8 %, mostly using stents, without significant adverse events. The mortality rate could be decreased from 40-100 to 17 %.

Fistula Plug in Fistulising Ano-Perineal Crohn's Disease: a Randomised Controlled Trial.

BACKGROUND AND AIMS: Anal fistula plug [AFP] is a bioabsorbable bioprosthesis used in ano-perineal fistula treatment. We aimed to assess efficacy and safety of AFP in fistulising ano-perineal Crohn's disease [FAP-CD]. METHODS: In a multicentre, open-label, randomised controlled trial we compared seton removal alone [control group] with AFP insertion [AFP group] in 106 Crohn's disease patients with non- or mildly active disease having at least one ano-perineal fistula tract drained for more than 1 month. Patients with abscess [collection ≥ 3mm on magnetic resonance imaging or recto-vaginal fistulas were excluded. Randomisation was stratified in simple or complex fistulas according to AGA classification. Primary end point was fistula closure at Week 12. RESULTS: In all, 54 patients were randomised to AFP group [control group 52]. Median fistula duration was 23 [10-53] months. Median Crohn's Disease Activity Index at baseline was 81 [45-135]. Fistula closure at Week 12 was achieved in 31.5% patients in the AFP group and in 23.1 % in the control group (relative risk [RR] stratified on AGA classification: 1.31; 95% confidence interval: 0.59-4.02; p = 0.19). No interaction in treatment effect with complexity stratum was found; 33.3% of patients with complex fistula and 30.8% of patients with simple fistula closed the tracts after AFP, as compared with 15.4% and 25.6% in controls, respectively [RR of success = 2.17 in complex fistula vs RR = 1.20 in simple fistula; p = 0.45]. Concerning safety, at Week 12, 17 patients developed at least one adverse event in the AFP group vs 8 in the controls [p = 0.07]. CONCLUSION: AFP is not more effective than seton removal alone to achieve FAP-CD closure.

Three-dimensional high-resolution anorectal manometry: does it allow automated analysis of sphincter defects?

AIM: Anorectal manometry is the most common test used to explore anorectal disorders. The recent three-dimensional high-resolution anorectal manometry (3D-HRAM) technique appears to be able to provide new topographic information. Our objective was to develop an automated analysis of 3D-HRAM images to diagnose anal sphincter defects and compare the results with those of endoanal ultrasonography (EUS), which is considered to be the gold standard. METHOD: All patients being tested in our department for faecal incontinence or dyschezia by 3D-HRAM and EUS were eligible for the study. 3D-HRAM was used to record resting and squeeze pressure, reflecting internal and external anal sphincter function, respectively. A software platform was designed to automatically analyse the 3D-HRAM images and calculate a diagnostic score for any anal sphincter defect compared with EUS. RESULTS: A total of 206 (91% female) patients of mean age of 54 years were included in the study. A sphincter defect was diagnosed by EUS in 130 (63%). The diagnostic scores from the 3D-HRAM automated analysis for an internal anal sphincter defect showed a sensitivity of 65% and a specificity of 65%. For an external anal sphincter defect, the sensitivity was 43% and the specificity 87%. CONCLUSION: Our study developed a method based on 3D-HRAM to automatically diagnose sphincter defects, allowing a systematic and comprehensive analysis of the test recordings. Compared with EUS, the 3D-HRAM image analysis procedure revealed poor sensitivity and specificity.

Double-type metallic stents efficacy for the management of post-operative fistulas, leakages, and perforations of the upper gastrointestinal tract.

INTRODUCTION: The management of post-operative anastomotic leakage and fistulas of the upper GI tract remains challenging. Fully covered stents are used despite a high risk of migration because of a better removability. The goal of our study was to evaluate the effectiveness of this new type of endoscopic stent in this indication. The secondary objective was to determine the ability of withdrawing this stent. METHODS: Thirty-six patients treated for upper GI fistula using a double-type metallic stent (DTMS) (Taewoong, Korea) for a benign indication were included in this retrospective study. This stent associates an outer uncovered metallic stent, decreasing the risk of migration, to an inner fully covered stent that ensured its tightness. The DTMS was removed after 4 weeks of treatment. RESULTS: Twenty-four patients had a post-operative fistula (15 sleeve gastrectomies), eight had an anastomotic leakage, and four had an esophageal perforation. Seventeen patients underwent a previous failed stenting, and fourteen had an associated treatment with OTSC clips. A final complete healing was achieved in twenty-six patients (72%). For patients with fistulas, the overall success rate was 66.6% (16/24) mostly in case of post sleeve fistula (80%), and it was 75% (6/8) for patients with anastomotic leakages (3/4). We reached a primary success (one session) in twenty-one cases (58.3%), and a second session was required in five cases. All the stents were removed without complications after a median stenting time of 32 [20-71] days. The spontaneous migration rate was 16.6%. CONCLUSION: This new double-type stent is a new and efficient way to treat post-operative fistulas and leakages in the upper GI tract. The stents were always removable despite the external uncovered part with a low migration rate.

Three-dimensional high-resolution anorectal manometry and diagnosis of excessive perineal descent: a comparative pilot study with defaecography.

AIM: Three-dimensional high-resolution anorectal manometry (3DHRAM) is a new technique that can simultaneously provide physiological and topographical data on the terminal part of the digestive tract. Our object was to assess whether 3DHRAM is able to reliably diagnose excessive perineal descent already diagnosed with conventional defaecography, which is considered to be the gold standard. METHOD: All patients referred to our centre for anorectal manometry and conventional defaecography were evaluated with a maximum of 6 months between the two examinations. Anorectal manometry was performed using the 3D High-Resolution Given Imaging® probe. Excessive perineal descent was defined as the downward movement of the anal high-pressure zone during straining. At the end of the straining effort, the high-pressure zone regained its initial position, thereby indicating that the probe had not moved. RESULTS: Nineteen female patients of median age 53 (21-70) years were included in the study. All cases with excessive perineal descent diagnosed using defaecography were visualized with 3DHRAM. The degree of perineal descent determined by 3D and conventional defaecography was compared (Spearman correlation 0.726, P = 0.01). In contrast, the averages measured were significantly different; the average was 11.68 ± 3.3 mm for 3DHRAM but 34.21 ± 13.3 mm for conventional defaecography (P = 0.002). CONCLUSION: The results of the study demonstrate that 3DHRAM can diagnose excessive perineal descent with the same degree of reliability as defaecography. Quantitative measures were not correlated, however, possibly because of methodological differences. The study confirms the value of the morphological data provided by 3DHRAM.

On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study.

BACKGROUND: In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients' quality of life (QoL). A randomised, double-blind, placebo-controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief. AIM: As IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on-demand ACS treatment vs. that of usual treatments. METHODS: Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on-demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6. RESULTS: A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p < 0.0008). The IBS-severity symptom score (IBS-SSS) was lower with ACS than in the usual treatment arm with a mean (SE) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An IBS-SSS < 75 was more frequent in the ACS group (37.7% vs. 16.0%; p < 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on-demand ACS treatment, which was associated with both lower direct and indirect costs. CONCLUSIONS: After 6 months, on-demand ACS treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments.

Water-perfused manometry vs three-dimensional high-resolution manometry: a comparative study on a large patient population with anorectal disorders.

AIM: Our aim was to compare for the first time measurements obtained with water-perfused catheter anorectal manometry and three-dimensional (3D) high-resolution manometry in patients with anorectal disorders. METHOD: Consecutive patients referred to our centre for anorectal manometry (ARM) were recruited to undergo the two procedures successively. Conventional manometry was carried out using a water-perfused catheter (WPAM) and high-resolution manometry was achieved with a 3D probe (3DHRAM). For each procedure, parameters recorded included the following: anal canal length, resting pressure, squeeze pressure and rectal sensitivity. RESULTS: Two hundred and one patients were included in this study. The mean values for resting and squeeze pressures were correlated and found to be significantly higher when measured with 3DHRAM than with WPAM. However, the length of the anal canal was not significantly different when measured by the two techniques without correlation between the two mean values obtained. The presence of the rectoanal inhibitory reflex was systematically assessed by both WPAM and 3DHRAM and anismus was also systematically diagnosed by both WPAM and 3DHRAM. CONCLUSION: The pressure values obtained with 3DHRAM are correlated with those measured with conventional manometry but are systematically higher. 3DHRAM has the advantage of providing a pressure recording over the entire length and circumference of the anal canal, allowing a more useful physiological assessment of anorectal function.

Serum calprotectin as a biomarker for Crohn's disease.

BACKGROUND AND AIMS: In Crohn's disease, correlation between clinical assessment and disease activity at tissue level is weak. Our aim was to evaluate the value of serum calprotectin as a biomarker for Crohn's disease. METHODS: The STORI trial patients (n=115) were studied at baseline, in clinical remission before infliximab withdrawal, or at the time of relapse after infliximab withdrawal. Forty healthy controls were also studied. Serum calprotectin level was measured by ELISA. Data were analyzed through correlation analyses, Kaplan Meier curves and Cox model, using available Crohn's Disease Activity Index (CDAI), Crohn's Disease Endoscopic Index of Severity (CDEIS), fecal calprotectin and C-reactive protein levels (hsCRP). RESULTS: Median serum calprotectin was 8892 ng/mL (range: 410-125,000 ng/mL) in Crohn disease patients as compared with 1318 ng/mL (range: 215.8-3770 ng/mL) in controls (P<0.0001). Serum calprotectin was significantly higher for active disease (median=19,584 ng/mL) than for inactive disease (median=8353 ng/mL) (P<0.0001). Serum calprotectin correlated with hsCRP (r=0.4092, P<0.0001) and CDAI (r=0.4442, P<0.0001), but not with CDEIS, on the contrary to fecal calprotectin (r=0.6458, 0.5515, 0.2577 with P<0.0001, P<0.0001, P=0.019 respectively). In multivariate analysis, serum calprotectin used as a discrete variable (threshold: 5675 ng/ml), appeared complementary to hsCRP (>5 mg/l) and fecal calprotectin (>250 µg/g) to predict relapse after infliximab withdrawal (P=0.0173, 0.0024 and 0.0002; HR: 3.191, 3.561 and 4.120). CONCLUSIONS: As a CD biomarker, serum calprotectin has a similar profile as hsCRP. It is also complementary to fecal calprotectin and hsCRP for prediction of relapse after infliximab withdrawal.

Comparison of three-dimensional high-resolution manometry and endoanal ultrasound in the diagnosis of anal sphincter defects.

AIM: Three-dimensional high-resolution anorectal manometry (3D HRAM) is a new technique that can simultaneously provide physiological and topographical data. Our aim was to assess whether it can identify anal sphincter defects by comparing it with endoanal ultrasonography (EUS) considered as the gold standard. METHOD: An anal defect on 3D HRAM was defined as a continuous circumferential area over which the pressure was < 10 mmHg during the measurement of anal resting and voluntary contraction pressure. Inter-observer agreement was also assessed. RESULTS: A total of 100 patients (93 females) with a mean age of 53.5 ± 15.3 years were included. The positive diagnosis of an anal sphincter defect using 3D HRAM and EUS was in agreement (59.3%) (κ = 0.419) of the time for the internal anal sphincter (IAS) and (55.9%) (κ = 0.461) for the external anal sphincter (EAS). The inter-observer agreement for a diagnosis of an anal sphincter defect was (100%) (κ = 0.937) for the IAS and (95%) (κ = 0.751) for the EAS. The intra-class correlation coefficient for the extent of the defect was 0.853 for the IAS and 0.651 for the EAS. CONCLUSION: The preliminary results demonstrate some level of agreement in the diagnosis of anal sphincter defects between 3D HRAM and EUS but insufficient for 3D HRAM to be adequately reliable using the criteria chosen. The excellent inter-observer agreement, however, demonstrates that 3D HRAM is reproducible and provides a new dimension for the evaluation of sphincter function.

Endoscopic ultrasound-guided vascular therapy: is it safe and effective?

Recent developments in therapeutic endoscopic ultrasound (EUS) have enabled new approaches to the management of refractory gastrointestinal bleeding, including EUS-guided sclerotherapy and vessel embolization. Few cases have been reported in the literature. Eight patients were admitted for severe, refractory gastrointestinal bleeding, seven of whom were actively bleeding. Causes of bleeding were gastric varices secondary to portal hypertension (n = 3); gastroduodenal artery aneurysm or fundal aneurysmal arterial malformation (n = 3); and Dieulafoy's ulcer (n = 2); the latter five patients having arterial bleeding. During the procedures, the bleeding vessel was punctured with a 19-gauge needle then injected with a sclerosing agent (cyanoacrylate glue [n = 6] or polidocanol 2 % [n = 2]) under Doppler control. The median follow-up time was 9 months (3 - 18 months). In all 10 endoscopic procedures were performed. The procedure was successful at the first attempt in seven out of eight patients (87.5 %). No clinical complications were observed, although in one case there was diffusion of cyanoacrylate in the hepatic artery. The seven successful cases all showed immediate and complete disappearance of the Doppler flow signal at the end of the procedure. This retrospective study highlights the utility of EUS-guided vascular therapy. However, more large randomized studies should be conducted to confirm these results.

Intramural esophageal dissection due to pharyngeal abscess treated by endoscopic esophageal transection: a case report.

Intramural esophageal dissection is a rare disorder characterized by extensive laceration between the mucosal and submucosal layers of the esophageal wall, but without perforation. The etiology of intramural dissection of the esophagus remains uncertain. Conservative management is usually considered adequate. Only one case of circumferential intramural esophageal dissection has been reported previously. We report here on a case due to an infectious cause (paryngeal abscess) that is also an unusual example of circumferential intramural esophageal dissection, which was then treated by endoscopic transection of the true internal esophageal wall and bougienage dilation.

[Cutaneous events during anti-TNF alpha therapy: a prospective observational study of 41 cases]. / Evénements cutanéomuqueux au cours des traitements par anti-TNF alpha : étude observationnelle prospective de 41 cas.

BACKGROUND: The cutaneous adverse effects of TNFalpha inhibitors and their potential implication in the onset of associated dermatoses remain poorly understood. PURPOSE: To describe the different clinical dermatological situations seen in patients treated with TNFalpha inhibitors. PATIENTS AND METHODS: We conducted a prospective, observational study of patients followed at the Dermatology Department of the CHU Nord university teaching hospital of Marseilles. All patients, referred by various departments, were treated with TNFalpha inhibitors and presented cutaneous events. RESULTS: Forty-one patients were included in the study. Various cutaneous manifestations were observed, including: 15 psoriatic rashes, six skin infections, three eczema rashes, three cases of lupic syndrome, two anaphylactic reactions to infusion and two cutaneous drug reactions. An original case of parapsoriasis was observed. Cutaneous tumors are rarely described. DISCUSSION: This study confirms the multiple clinical dermatological situations observed in patients treated with TNFalpha inhibitors and illustrates the need for good coordination between dermatologists and other specialists in order to ensure optimal management of this population.

[Chromoendoscopy in inflammatory bowel disease]. / Coloration et maladies inflammatoires chroniques de l'intestin (MICI).

The risk of colorectal cancer in case of IBD-related pancolitis reaches 2% after 10 years follow-up, 8% after 20 years up to 18% at 30 years, and was probably over-estimated in the first series. Chromoendoscopy appears to be helpful in the surveillance of IBD, and moreover recommended, using carmine indigo or methylene blue with a well-standardized procedure. Its place regarding other techniques like virtual coloration has to be clarified with randomized studies. The chromoendoscopy allows the operator to perform targeted biopsies, which appear to be more efficient for the detection of dysplasia than systematic biopsies performed every 10 cm. Nevertheless, it is too soon to remove systematic biopsies from scientific recommendations.

What is the outcome for patients presenting with severe acute pancreatitis requiring a hospital stay of more than one month?

OBJECTIVE: The aim of this study was to investigate the clinical progression of patients who had severe acute pancreatitis (AP) and a stay in hospital of more than a month. METHODS: A total of 24 patients (median age: 57 years) were included in this eight-year retrospective study. Cure was defined as the restoration of the pancreatic parenchyma, and the disappearance of all pseudocysts and pancreatic fistulae. Data including the duration of hospital stay, disease severity and pancreatic sequelae were also collected. RESULTS: The median total duration of the hospital stay was 67 days. The overall mortality rate was 20.8%, whereas the mortality rate due to AP was 12.5%. The average healing period was 7.7 months. On univariate analysis, patients who also had respiratory diseases, chronic alcoholism, necrotizing superinfection, pseudocyst, food intolerance and/or hospital-acquired infection took significantly longer to heal. After cure, we observed pancreatic and/or hepatic duct stenoses in 50% of cases, and the onset or aggravation of diabetes in 25%. CONCLUSION: In patients hospitalized for more than one month because of necrotizing AP, the rate of mortality is around 20%, with a final hospital stay of two months and a healing period of more than seven months. In addition, half of the patients presented with pancreatic or biliary sequelae.

Relationship between rectal sensitivity, symptoms intensity and quality of life in patients with irritable bowel syndrome.

BACKGROUND: Relationships between pain threshold during rectal distension and both symptoms intensity and alteration in quality of life (QoL) in irritable bowel syndrome (IBS) patients have been poorly evaluated. AIM: To evaluate relationships between rectal sensitivity, IBS symptom intensity and QoL in a multicentre prospective study. METHODS: Rectal threshold for moderate pain was measured during rectal distension in IBS patients (Rome II), while IBS symptoms intensity was assessed by a validated questionnaire and QoL by the Functional Digestive Disorder Quality of Life questionnaire. RESULTS: Sixty-eight patients (44.2 +/- 12.7 years, 48 women) were included. The mean rectal distending volume for moderate pain was 127 +/- 35 mL while 45 patients (66%) had rectal hypersensitivity (pain threshold <140 mL). Rectal threshold was not significantly related either to overall IBS intensity score (r = -0.66, P = 0.62) or to its different components, or to FDDQL score (r = 0.30, P = 0.14). Among FDDQL domains, only anxiety (r = 0.30, P = 0.01) and coping (r = 0.31, P = 0.009) were significantly related with pain threshold. CONCLUSIONS: In this study, two-thirds of IBS patients exhibited rectal hypersensitivity. No significant correlation was found between rectal threshold and either symptom intensity or alteration in QoL.