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Clinical Trials/NCT05171088
NCT05171088
Completed
Not Applicable

Colorectal Resection in Emergency General Surgery - To Anastomose, or Not to Anastomose

Methodist Health System1 site in 1 country16 target enrollmentApril 4, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Resection
Sponsor
Methodist Health System
Enrollment
16
Locations
1
Primary Endpoint
Perioperative mortality and need for unplanned procedural intervention
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Primary anastomosis is associated with higher rates of perioperative morbidity/mortality and that fecal diversion improves overall mortality, decreases length of stay, and lowers rates of surgical complications requiring unplanned operative intervention.

Detailed Description

This is a prospective observational study. All patients undergoing colon resection in the urgent/emergent setting meeting our inclusion/exclusion criteria will be enrolled in the study. Data will be collected prospectively and the decision to perform proximal diversion or anastomosis is solely the responsibility of the managing acute care surgeon. No guidelines or protocols will be suggested so as to avoid any influence on practitioner decision-making. The plan is to complete the data collection and analysis by 03/01/2020

Registry
clinicaltrials.gov
Start Date
April 4, 2018
End Date
March 8, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing urgent/emergent colon resection (less than 24 hours after decision to operate) by an acute care surgeon

Exclusion Criteria

  • Elective operations performed by acute care surgeons within 24-hours of the decision to operate (e.g., scheduled resection of non-obstructed, non-perforated malignancy)
  • Prisoners
  • Pregnancy
  • Wards of the state
  • Patients less than 18-years of age
  • Traumatic mechanisms of injury
  • Death within 24-hours of index operation

Outcomes

Primary Outcomes

Perioperative mortality and need for unplanned procedural intervention

Time Frame: 1 days to 12 months

Perioperative mortality and need for unplanned procedural intervention (intervention by a surgeon, radiologist, or interventional radiologist).

Study Sites (1)

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