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The purpose of this study is to determine whether mesalamine is effective vs. placebo in the prevention of diverticulitis flares in a 24-months follow-up.
The primary end-point of the study is the incidence of diverticulitis flares. Will be made a clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and altered intestinal motility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesalamine | Active Comparator | Posology: mesalamine: 1,6 g/die for ten days every month for 24 months |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesalamine | Drug | mesalamine: 1.6 g/die for ten days/month until 24 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| diverticulitis relapse | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale di Seriate | Seriate | Bergamo | Italy | |||
| Ospedale di Esine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23754545 | Derived | Parente F, Bargiggia S, Prada A, Bortoli A, Giacosa A, Germana B, Ferrari A, Casella G, De Pretis G, Miori G; "Gismi Study Group". Intermittent treatment with mesalazine in the prevention of diverticulitis recurrence: a randomised multicentre pilot double-blind placebo-controlled study of 24-month duration. Int J Colorectal Dis. 2013 Oct;28(10):1423-31. doi: 10.1007/s00384-013-1722-9. Epub 2013 Jun 12. |
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| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| placebo |
| Other |
2 pills/day for ten days/month until 24 months |
|
| Esine |
| Brescia |
| Italy |
| Ospedale Maggiore | Crema | Cremona | Italy |
| Ospedale di Desio | Desio | Milano | Italy |
| Ospedale di Garbagnate M.se | Garbagnate Milanese | Milano | Italy |
| Ospedale C. Borella | Giussano | Milano | Italy |
| Ospedale Civile | Legnano | Milano | Italy |
| A.O. G. Salvini | Rho (MI) | Milano | 20017 | Italy |
| Policlinico di Monza | Monza | Monza-Brianza | Italy |
| Ospedale S. Antonio Abate | Gallarate | Varese | Italy |
| Azienda ULSS | Belluno | Italy |
| Poliambulanza | Brescia | Italy |
| Ospedale A. Manzoni | Lecco | Italy |
| Ospedale G. Bosco | Torino | Italy |
| Ospedale Maria Vittoria | Torino | Italy |
| Ospedale Molinette | Torino | Italy |
| Ospedale S. Chiara | Trento | Italy |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |