1 Department of Clinical Medicine - Department of Clinical Epidemiology, Department of Clinical Medicine, Health, Aarhus University2 Institut for Klinisk Medicin3 unknown4 Department of Clinical Medicine - Department of Clinical Epidemiology, Department of Clinical Medicine, Health, Aarhus University
Abstract 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. Material and methods. 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 ).
Scandinavian Journal of Gastroenterology, 2013, Vol 48, Issue 2, p. 168-75
Adolescent; Adult; Aged; Aged, 80 and over; Denmark; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peptic Ulcer Perforation; Perioperative Care; Postoperative Complications; Practice Guidelines as Topic; Prospective Studies; Sepsis; Treatment Outcome; Young Adult; Controlled Clinical Trial; Journal Article; Multicenter Study