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P043 BUDESONIDE MMX IS EFFICIENT AND SAFE IN PATIENTS WITH ACTIVE LEFT-SIDED ULCERATIVE COLITIS
14 fliximab treatment respectively,(P=0.36). Mean serum resistin levels were 26.3±4.1 ng/ml and 13.9±1.4 ng/ml before and after infliximab treatment respectively,(P=0.004). No significant differences were found between patients with clinical response and clinical remission after infliximab therapy, concerning the circulating levels of the examined adipocytokines (P>0.05). Furthermore no significant correlations between changes of serum adipocytokines and alterations of the BMI after therapy were found. Conclusions: Serum levels of leptin and adiponectin have no significant alterations after infliximab treatment in patients with IBD. On the other hand, serum resistin levels are significantly decreased after infliximab therapy suggesting a possible proinflammatory status of this adipocytokine in IBD and a close relationship with TNF alpha levels.
P040 DEVELOPMENT OF AN EDUCATIONAL NUTRITIONAL (COOKING) PROGRAM FOR CROHN' S DISEASE PATIENTS R. Polak, E. Goldin, O. Sasson, E. Israeli. Hadassah University Hospital Background: Crohn' s disease (CD) patients have to follow specific, often very strict, nutritional recommendations. 0bjective: To develop a practical "hands on", educational-program (Cooking workshop) to help Crohn' s disease patients understand nutritional recommendations, and to improve their healthrelated quality of life (HRQOL). Design: The educational program consisted of seven meetings based on specific dietary recommendations. Each meeting started with a half hour theoretical introduction, written and taught by a registered dietitian, followed by a 2.5 hours "hands on" session under supervision of a medical student and professional chef. In those sessions, patients familiarized themselves with special recipes, skills and ingredients relevant to the recommendations that had been taught in the preceding introduction. At the end of each meeting the participants ate the meals they had prepared during that meeting in a relaxed atmosphere at a communal dinner. 18 patients participated in the program and were compared to a control-group of 12 patients. The control patients were only exposed to the theoretical part of the meetings. HRQOL was assessed using the Inflammatory Bowel Disease questionnaire (IBDQ), the severity of the disease using the Crohn' s Disease Activity Index (CDAI), the nutritional status using biochemical markers and the patients' satisfaction using a study specific questionnaire. Results: Following the intervention there was significant decrease in the CDAI (165.2±89 vs. 116.7±75) and an improvement in some of the nutritional markers, but no significant change was found in the IBDQ (158±31 vs.164±32). All patients were generally satisfied with the program and even more so with the ' hands on' sessions. Conclusions: An educational nutritional program for CD patients may be a useful and enjoyable tool. This intervention may also be effective as a therapeutic tool, but further studies must be done with larger numbers of participants and a better patient selection.
P041 QUALITY OF LIFE AFTER RESTORATIVE PROCTOCOLECTOMY FOR ULCERATIVE COLITIS M. Tariverdian, C. Leowardi, U. Hinz, T. Welsch, J. Schmidt, P. Kienle. University of Heidelberg Background: Restorative proctocolectomy has become the surgical procedure of choice in patients with ulcerative colitis. Only smaller studies have compared postoperative to preoperative quality of life with a standardized disease-specific questionnaire. Materials and Methods: Patients with ulcerative colitis who had undergone resorative proctocolectomy at least five years before and who had filled out a disease-specific validated questionnaire (GIQLI) on quality of life prior to surgery (n=128) were included into this follow-up study. Factors potentially influencing quality of life at the time of operation were investigated in regard to pre- and postoperative quality of life in univariate and multivariate analysis. Results: 105 patients responded (82%). Quality of life at least five years after colectomy was significantly improved compared to the preoperative situation (median GIQLI 109 versus 75). This improvement was evident in all five dimensions of the index (p<0,0001). The CAI (p<0,00001), a shorter duration of the disease (p<0,05) and a three-staged procedure (<0,001) were all negatively correlated with preoperative quality of life, whereas neoplasia (p<0,001) was positively correlated. Colectomy was the reason for most of the increase in quality of life. Ileostomy closure resulted in a further improvement in three of five dimensions but not in overall quality of life. Uniand multivariate analysis of the difference in quality of life before and five years after colectomy revealed CAI, the type of operation (both p<0,001) and neoplasia as significant factors (p<0,05).
Poster Presentations Conclusion: Patients with high activity of ulcerative colitis, predominantly those operated for severe disease refractory to medical treatment, showed the highest improvement in quality of life. In conclusion, the patients in the worst clinical situation profit the most from restorative proctocolectomy.
P042 POUCH SURGERY OFFERS A GOOD QUALITY OF LIFE DESPITE ONGOING PROBLEMS M. Bortlik, D. Duricova, M. Lukas. General Teaching Hospital, 1st School of Medicine, Charles University, Prague Introduction: Proctocolectomy with ileal pouch-anal anastomosis (IPAA) is thought to be the best option for patients with intractable ulcerative colitis (UC). Despite removing entire inflammed bowel, several symptoms usually persist in most patients with IPAA. Aims and methods: To assess a functional status and quality of life, we performed a retrospective analysis in 20 patients with UC and IPAA. We looked at the course of the disease prior to and after IPAA (e.g. corticodependency and corticoresistency, type of pouch, frequency of pouchitis or other complications) and assess the functionality of the pouch and quality of life (QOL) in all patients. We used questionnaires for functional outcome, fecal continence and QOL assessment. Results: Thirteen patients had corticodependent and 7 corticoresistant disease, most operations were 3-step procedures. Fourty percent of our patients experienced at least one course of pouchitis. Regarding the functionality of the IPAA, the mean number of soft stools was 6 during the day and 2 at the night, with rare incontinency but frequent difficulty to differentiate between the stool and gas when urgency occurs. Most patients had to modify their activities according to the intensity of bowel problems, more than one third use regularly the antidiarrheals. Evaluation of the quality of life assessed by the Cleveland Global Quality of Life (CGQL) questionaire revealed in our patients the mean score of 0.73, which is a result similar to what has been described in patients with IPAA by others. It is obviously higher than CGQL score described in UC patients with intractable UC pre-operatively. Conclusions: Proctocolectomy with IPAA improves the quality of life, but does not cure UC without functional consequences. Most patients had to modify their life in accordance with the intensity of their bowel problems. These results should be considered when deciding on therapeutic modality in UC patient.
P043 BUDESONIDE MMX IS EFFICIENT AND SAFE IN PATIENTS WITH ACTIVE LEFT-SIDED ULCERATIVE COLITIS G. D' Haens 1 , Á. Kovács 2 , P. Vergauwe 3 , J. Lonovics 4 , Y. Bouhnik 5 , W. Weiss 6 , H. Brunner 7 , A. Lavergne-Slove 5 , A. Di Stefano, P. Marteau 8 . 1 Imelda GI Clinical Research Center, Bonheiden, Belgium; 2 Capital hospital of Péterfy Sándor' s street, Budapest, Hungary; 3 General Hospital Groeninge, Kortrijk, Belgium; 4 Science University of Szeged, Hungary; 5 Hôpital Lariboisière, Paris, France; 6 Krankenanstalt Rudolfstiftung, Austria; 7 Krankenhaus Lainz, Vienna, Austria; 8 Hôpital Européen Georges Pompidou, Paris, France Ulcerative colitis (UC) is characterized by episodes of relapse and remission. Many patients need systemic corticosteroids, leading to important toxicity. Goal: to study the safety and efficacy of MMX budesonide (BUD), a topical steroid, in active left-sided UC. Methods: Thirty-six patients with moderately active left-sided UC (CAI or colitis activity index 4-14) were treated with 9 mg MMX-BUD extended release (Cosmo S.p.A., Italy) for 8 weeks or placebo (PLA) for 4 weeks followed by 9 mg MMX-BUD for 4 weeks, all given as single tablet in the morning. Background therapy was kept unchanged; topical therapy, antibiotics, biologics and systemic steroids were prohibited. The primary endpoint was the proportion of patients with a CAI reduction of at least 50% or remission (CAI =<4) at week 4; secondary endpoints included the proportion of patients with a 70% reduction in CAI after 8 weeks of 9 mg MMX-BUD and morning cortisol levels and a short ACTH-test performed at week 4 and 8. Results: 32 patients were available for analysis, with comparable characteristics in both groups. The primary endpoint was reached by 8/17 (47.1%) patients in the BUD group and 5/15 (33.3%) in the PLA group (NS). Lack of significance is probably due to the small sample size. No change or worsening disease was seen in 1/17 BUD and 5/15 PLA patients. The CAI decreased significantly from baseline to week 4 with BUD (p<0.0001) but not with placebo (p=0.1). Adverse events included headache (11.9%) and abdominal pain (8.5%). Changes in plasma cortisol levels and ACTH tests were similar in both groups. Conclusions: 4 weeks of treatment with 9 mg MMX- Budesonide induces clinical improvement in patients with active left-sided UC without significant suppression of the cortisol axis Larger controlled trials are warranted.
P040 DEVELOPMENT OF AN EDUCATIONAL NUTRITIONAL (COOKING) PROGRAM FOR CROHN' S DISEASE PATIENTS R. Polak, E. Goldin, O. Sasson, E. Israeli. Hadassah University Hospital Background: Crohn' s disease (CD) patients have to follow specific, often very strict, nutritional recommendations. 0bjective: To develop a practical "hands on", educational-program (Cooking workshop) to help Crohn' s disease patients understand nutritional recommendations, and to improve their healthrelated quality of life (HRQOL). Design: The educational program consisted of seven meetings based on specific dietary recommendations. Each meeting started with a half hour theoretical introduction, written and taught by a registered dietitian, followed by a 2.5 hours "hands on" session under supervision of a medical student and professional chef. In those sessions, patients familiarized themselves with special recipes, skills and ingredients relevant to the recommendations that had been taught in the preceding introduction. At the end of each meeting the participants ate the meals they had prepared during that meeting in a relaxed atmosphere at a communal dinner. 18 patients participated in the program and were compared to a control-group of 12 patients. The control patients were only exposed to the theoretical part of the meetings. HRQOL was assessed using the Inflammatory Bowel Disease questionnaire (IBDQ), the severity of the disease using the Crohn' s Disease Activity Index (CDAI), the nutritional status using biochemical markers and the patients' satisfaction using a study specific questionnaire. Results: Following the intervention there was significant decrease in the CDAI (165.2±89 vs. 116.7±75) and an improvement in some of the nutritional markers, but no significant change was found in the IBDQ (158±31 vs.164±32). All patients were generally satisfied with the program and even more so with the ' hands on' sessions. Conclusions: An educational nutritional program for CD patients may be a useful and enjoyable tool. This intervention may also be effective as a therapeutic tool, but further studies must be done with larger numbers of participants and a better patient selection.
P041 QUALITY OF LIFE AFTER RESTORATIVE PROCTOCOLECTOMY FOR ULCERATIVE COLITIS M. Tariverdian, C. Leowardi, U. Hinz, T. Welsch, J. Schmidt, P. Kienle. University of Heidelberg Background: Restorative proctocolectomy has become the surgical procedure of choice in patients with ulcerative colitis. Only smaller studies have compared postoperative to preoperative quality of life with a standardized disease-specific questionnaire. Materials and Methods: Patients with ulcerative colitis who had undergone resorative proctocolectomy at least five years before and who had filled out a disease-specific validated questionnaire (GIQLI) on quality of life prior to surgery (n=128) were included into this follow-up study. Factors potentially influencing quality of life at the time of operation were investigated in regard to pre- and postoperative quality of life in univariate and multivariate analysis. Results: 105 patients responded (82%). Quality of life at least five years after colectomy was significantly improved compared to the preoperative situation (median GIQLI 109 versus 75). This improvement was evident in all five dimensions of the index (p<0,0001). The CAI (p<0,00001), a shorter duration of the disease (p<0,05) and a three-staged procedure (<0,001) were all negatively correlated with preoperative quality of life, whereas neoplasia (p<0,001) was positively correlated. Colectomy was the reason for most of the increase in quality of life. Ileostomy closure resulted in a further improvement in three of five dimensions but not in overall quality of life. Uniand multivariate analysis of the difference in quality of life before and five years after colectomy revealed CAI, the type of operation (both p<0,001) and neoplasia as significant factors (p<0,05).
Poster Presentations Conclusion: Patients with high activity of ulcerative colitis, predominantly those operated for severe disease refractory to medical treatment, showed the highest improvement in quality of life. In conclusion, the patients in the worst clinical situation profit the most from restorative proctocolectomy.
P042 POUCH SURGERY OFFERS A GOOD QUALITY OF LIFE DESPITE ONGOING PROBLEMS M. Bortlik, D. Duricova, M. Lukas. General Teaching Hospital, 1st School of Medicine, Charles University, Prague Introduction: Proctocolectomy with ileal pouch-anal anastomosis (IPAA) is thought to be the best option for patients with intractable ulcerative colitis (UC). Despite removing entire inflammed bowel, several symptoms usually persist in most patients with IPAA. Aims and methods: To assess a functional status and quality of life, we performed a retrospective analysis in 20 patients with UC and IPAA. We looked at the course of the disease prior to and after IPAA (e.g. corticodependency and corticoresistency, type of pouch, frequency of pouchitis or other complications) and assess the functionality of the pouch and quality of life (QOL) in all patients. We used questionnaires for functional outcome, fecal continence and QOL assessment. Results: Thirteen patients had corticodependent and 7 corticoresistant disease, most operations were 3-step procedures. Fourty percent of our patients experienced at least one course of pouchitis. Regarding the functionality of the IPAA, the mean number of soft stools was 6 during the day and 2 at the night, with rare incontinency but frequent difficulty to differentiate between the stool and gas when urgency occurs. Most patients had to modify their activities according to the intensity of bowel problems, more than one third use regularly the antidiarrheals. Evaluation of the quality of life assessed by the Cleveland Global Quality of Life (CGQL) questionaire revealed in our patients the mean score of 0.73, which is a result similar to what has been described in patients with IPAA by others. It is obviously higher than CGQL score described in UC patients with intractable UC pre-operatively. Conclusions: Proctocolectomy with IPAA improves the quality of life, but does not cure UC without functional consequences. Most patients had to modify their life in accordance with the intensity of their bowel problems. These results should be considered when deciding on therapeutic modality in UC patient.
P043 BUDESONIDE MMX IS EFFICIENT AND SAFE IN PATIENTS WITH ACTIVE LEFT-SIDED ULCERATIVE COLITIS G. D' Haens 1 , Á. Kovács 2 , P. Vergauwe 3 , J. Lonovics 4 , Y. Bouhnik 5 , W. Weiss 6 , H. Brunner 7 , A. Lavergne-Slove 5 , A. Di Stefano, P. Marteau 8 . 1 Imelda GI Clinical Research Center, Bonheiden, Belgium; 2 Capital hospital of Péterfy Sándor' s street, Budapest, Hungary; 3 General Hospital Groeninge, Kortrijk, Belgium; 4 Science University of Szeged, Hungary; 5 Hôpital Lariboisière, Paris, France; 6 Krankenanstalt Rudolfstiftung, Austria; 7 Krankenhaus Lainz, Vienna, Austria; 8 Hôpital Européen Georges Pompidou, Paris, France Ulcerative colitis (UC) is characterized by episodes of relapse and remission. Many patients need systemic corticosteroids, leading to important toxicity. Goal: to study the safety and efficacy of MMX budesonide (BUD), a topical steroid, in active left-sided UC. Methods: Thirty-six patients with moderately active left-sided UC (CAI or colitis activity index 4-14) were treated with 9 mg MMX-BUD extended release (Cosmo S.p.A., Italy) for 8 weeks or placebo (PLA) for 4 weeks followed by 9 mg MMX-BUD for 4 weeks, all given as single tablet in the morning. Background therapy was kept unchanged; topical therapy, antibiotics, biologics and systemic steroids were prohibited. The primary endpoint was the proportion of patients with a CAI reduction of at least 50% or remission (CAI =<4) at week 4; secondary endpoints included the proportion of patients with a 70% reduction in CAI after 8 weeks of 9 mg MMX-BUD and morning cortisol levels and a short ACTH-test performed at week 4 and 8. Results: 32 patients were available for analysis, with comparable characteristics in both groups. The primary endpoint was reached by 8/17 (47.1%) patients in the BUD group and 5/15 (33.3%) in the PLA group (NS). Lack of significance is probably due to the small sample size. No change or worsening disease was seen in 1/17 BUD and 5/15 PLA patients. The CAI decreased significantly from baseline to week 4 with BUD (p<0.0001) but not with placebo (p=0.1). Adverse events included headache (11.9%) and abdominal pain (8.5%). Changes in plasma cortisol levels and ACTH tests were similar in both groups. Conclusions: 4 weeks of treatment with 9 mg MMX- Budesonide induces clinical improvement in patients with active left-sided UC without significant suppression of the cortisol axis Larger controlled trials are warranted.