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Is TIme From adMission to surgEry an Independent Prognostic Factor for Survival of Patients With Gastro-intestinal Perforation Associated With Septic Shock: (TIME) An Italian Intersocietary Retrospective and Prospective Observational Trial

NCT04811755 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3276

Last updated 2021-03-23

No results posted yet for this study

Summary

Gastro-intestinal perforation is a condition that can become life-threatening in case of appearance of systemic symptoms, sepsis-related peripheral hypoperfusion and single or multiple organ failure needing a prompt intervention in Emergency Department (ED) setting. Literature reports disagreeing data about the effect of surgical timing on mortality and postoperative outcomes: Buck et al. described a 2.4 % of decreased survival every hour of surgical delay in case of perforated peptic ulcers. Other authors documented significantly longer postoperative hospital stay, greater health costs and a significant increase of postoperative complication and mortality rates when surgery is delayed in high-risk patients with comorbidities or age \> 65 years. Azuhata described a highly significant relationship between delayed surgery and patients' survival: after 6 hours from admission to ED, patients with gastrointestinal perforation and associated septic shock don't survive to surgery. The aim of this study is to assess the impact of delay of time between patient admission to ED and surgery for source control on 30-d mortality and postoperative outcomes in patients with gastrointestinal perforation with or without septic shock. Furthermore, we want to define the time threshold within which surgery can affect patients' survival.

Conditions

  • Emergency Surgery

Interventions

BEHAVIORAL

Surgical timing from ED admission to surgery

the impact of delay of time between patient admission to ED and surgery for source control on 90-d mortality and postoperative outcomes in patients with gastrointestinal perforation with or without septic shock

Sponsors & Collaborators

  • San Luigi Gonzaga Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-01
Primary Completion
2022-12-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04811755 on ClinicalTrials.gov