Ribas 2010.
| Study characteristics | ||
| Methods | RCT, parallel, multicentre (2 hospitals in Spain), pilot study | |
| Participants | 50 patients randomised, 44 analysed, 22 from each group Inclusion: Abdominal pain localised to left lower quadrant and tenderness at examination, CT (within 24‐48 h) with bowel wall thickness and pericolic fat infiltration Exclusion: Complicated diverticulitis on CT or clinical suspicion |
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| Interventions |
Intervention: Short IV: IV AB for 24‐48 hours + 10 days of oral AB
Control: Long IV: IV AB for 7 days + 5 days of oral AB Amoxicillin‐clavulanic acid was used for both administration routes and intervention groups with the same dose (1 g/8h). Total duration of treatment was 12 days in both groups. |
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| Outcomes |
Failure of treatment: (Short IV: 1 vs. long IV: 2) 1. Not able to discharge participant because of symptoms on fourth (short‐IV) or eighth (long‐IV) day 2. Emergency admission after discharge for reasons related to diverticulitis 3. Hospital readmission with the same diagnosis within 30 days Late complications: Colonoscopy 4‐6 weeks after discharge (Short IV: 1 vs. long IV: 1) |
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| Notes | This study was supported by a grant from the Fundació Joan Costa Roma of the Consorci Sanitari de Terrassa. The authors declare no conflict of interest. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised by a computer‐generated randomisation list that was prepared by an external observant |
| Allocation concealment (selection bias) | Low risk | Allocated by means of numbered sealed envelopes that corresponded to the randomisation list. The envelopes were opened after the written consent was provided. |
| Blinding (performance bias and detection bias) All outcomes | High risk | No blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout after randomisation: 6 excluded because of withdrawal of consent or different CT diagnosis. No participants were excluded from analysis. 3 participants (Short‐IV: 2 vs. long‐IV: 1) had failure of treatment and could not be discharged. From author: None of the 3 participants required surgery or had re‐evaluation on CT. The participants had persistent pain and therefore could not be discharged on scheduled day. Interpretation: Failure of treatment in participants was not because of complications that required emergency surgery. |
| Selective reporting (reporting bias) | Low risk | No specification of a protocol in the study. All defined outcomes in method section are reported and assessed. From author: "a document [protocol] was written in Catalan. The article summarizes quite well what we did, the inclusion and exclusion criteria, the two groups with different treatments, as well as the outcomes". Interpretation: Relevant outcomes and relevant outcome reporting when combining article and comments plus data from author. |
AB: antibiotic ASA: American Society of Anaesthesiologists physical status classification AVOD: Antibiotika Vid Okomplicerad Divertikulit – Swedish for ‘antibiotics in uncomplicated diverticulitis’ DIABOLO: DIverticulitis AntiBiotic Or cLose Observation IV: intravenous vs.: versus NSAID: nonsteroidal anti‐inflammatory drugs PaCO2: The partial pressure of carbon diaoxid in arterial blood; RCT: randomised controlled trial STAND: Selective Treatment with Antibiotics for Non‐complicated Diverticulitis