NCT06074432

Brief Summary

Study is designed to investigate the risk factors associated with morbidity and mortality in patients who underwent emergency resection because of colorectal cancer in general surgery clinic of a tertiary referral hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 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

July 25, 2023

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 29, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

16 days

First QC Date

September 29, 2023

Last Update Submit

October 6, 2023

Conditions

Keywords

Emergency TreatmentColorectal CancerMortalityMorbidityRisk Factors

Outcome Measures

Primary Outcomes (2)

  • Morbidity

    Patients developed a major complication that has a Clavien-Dindo Score ≥3

    Until postoperative 90 days

  • Mortality

    Patients died in the postoperative period within 90 days

    Until postoperative 90 days

Study Arms (1)

Emergency Colorectal Cancer Resection

Patients that underwent emergent resection because of histopathologically confirmed colorectal carcinoma

Other: Emergency Colorectal Resection

Interventions

Patients underwent resection due to colorectal carcinoma in emergency surgery

Emergency Colorectal Cancer Resection

Eligibility Criteria

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

Patients who underwent emergency colorectal resection between January 2019 and December 2022

You may qualify if:

  • Patients who underwent emergency colorectal resection between January,1 2019 and December,31 2022 were included. All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms

You may not qualify if:

  • Patients operated with a different indication from primary colorectal cancer such as diverticulitis, ischemia, inflammatory bowel diseases or metastases of another malignancy
  • Patients with insufficient clinical data were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırkoy Dr.Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Mehmet Karabulut

    University of Health Sciences, Bakirkoy Dr.Sadi Konuk Training and Research

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 10, 2023

Study Start

July 25, 2023

Primary Completion

August 10, 2023

Study Completion

August 30, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations