CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RESEARCH SUPPORT, NON-U.S. GOV'T
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Multicentre trial of a perioperative protocol to reduce mortality in patients with peptic ulcer perforation.

BACKGROUND: Morbidity and mortality rates in patients with perforated peptic ulcer (PPU) remain substantial. The aim of the present study was to evaluate the effect of a multimodal and multidisciplinary perioperative care protocol on mortality in patients with PPU.

METHODS: This was an externally controlled multicentre trial set in seven gastrointestinal departments in Denmark. Consecutive patients who underwent surgery for gastric or duodenal PPU between 1 January 2008 and 31 December 2009 were treated according to a multimodal and multidisciplinary evidence-based perioperative care protocol. The 30-day mortality rate in this group was compared with rates in historical and concurrent national controls.

RESULTS: The 30-day mortality rate following PPU was 17·1 per cent in the intervention group, compared with 27·0 per cent in the three control groups (P = 0·005). This corresponded to a relative risk of 0·63 (95 per cent confidence interval 0·41 to 0·97), a relative risk reduction of 37 (5 to 58) per cent and a number needed to treat of 10 (6 to 38).

CONCLUSION: The 30-day mortality rate in patients with PPU was reduced by more than one-third after the implementation of a multimodal and multidisciplinary perioperative care protocol, compared with conventional treatment.

REGISTRATION NUMBER: NCT00624169 (https://www.clinicaltrials.gov).

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