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Long-term mortality following peptic ulcer perforation in the PULP trial. A nationwide follow-up study
Morten Hylander Møller1, Morten Vester-Andersen, Reimar Wernich Thomsen
1Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. mortenhylander@gmail.com
Objective:
Morbidity and mortality following perforated peptic ulcer (PPU) remain substantial. In the recently published PULP trial, 30-day mortality in patients surgically treated for PPU decreased from 27% to 17% following the implementation of a perioperative care protocol based on The Surviving Sepsis Guidelines. The objective of the present study was to evaluate long-term mortality in the PULP trial intervention and control cohort.
Design:
nationwide follow-up study of a multicenter, non-randomized, clinical trial with external controls.
Setting:
Danish patients surgically treated for PPU between 1 January 2008 and 31 December 2009.
Patients:
117 patients in the intervention group and 512 in the control group.
Intervention:
a perioperative care protocol based on The Surviving Sepsis Guidelines.
Outcome Measures:
60-day, 90-day, 180-day, 1-year, and 2-year mortality rates.
Statistical Analysis:
survival statistics.
Results:
Baseline characteristics, clinical, and perioperative data were in general, similar in the intervention and control group. Sixty days postoperatively, the originally observed difference in 30-day mortality had diminished (25% vs. 30%, p = 0.268). After 180 days, the mortality difference was reduced additionally (31% vs. 33%, p = 0.645), and one year postoperatively, a mortality difference was no longer present (36% in both groups, p = 0.993). Two years postoperatively, the mortality rate in the intervention group was 44%, as compared to 40% in the control group (p = 0.472).
Conclusions:
The survival benefit associated with a perioperative care protocol in patients treated for PPU decreases progressively after 30 days and is no longer present after one year.
Registration Number:
NCT00624169 ( http://www.clinicaltrials.gov ).
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