Colorectal Resection in Emergency General Surgery

Colorectal Resection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05171088
• Other study ID #: 100.GME.2018.D
• Status: Completed
• Start date: April 4, 2018
• Est. completion date: March 8, 2021

Study information

• Verified date: December 2021
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Resection
• Emergencies

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative mortality and need for unplanned procedural intervention	Perioperative mortality and need for unplanned procedural intervention (intervention by a surgeon, radiologist, or interventional radiologist).	1 days to 12 months