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OpenTrials
Completed

NCT Number: NCT05171088

Colorectal Resection in Emergency General Surgery

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.

Completed

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Key information

Conditions

Colorectal Resection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2021
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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