NCT05171088

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2021

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

2.9 years

First QC Date

November 18, 2020

Last Update Submit

December 9, 2021

Conditions

Colorectal Resection

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing colon resection at Methodist Dallas Medical Center in the urgent/emergent setting meeting our inclusion/exclusion criteria will be enrolled in the study.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Study Officials

  • Michael Truitt, M.D.

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

December 28, 2021

Study Start

April 4, 2018

Primary Completion

March 8, 2021

Study Completion

March 8, 2021

Last Updated

December 28, 2021

Record last verified: 2021-12

Locations

US(1)