Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
Primary Purpose
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Resection
Stoma
Sponsored by
About this trial
This is an interventional treatment trial for Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patient aged above 18 years admitted at Mansoura University Hospitals complaining from intestinal obstruction due to obstructed left sided carcinoma.
Exclusion Criteria:
- Treatment with non-surgical intervention or spontaneous relief of obstruction
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Stoma
Resection and stoma
Arm Description
Outcomes
Primary Outcome Measures
Risk Factors for Mortality in cases of obstructed left colonic Carcinoma
Predictors of mortality after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04823416
Brief Title
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
Official Title
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
March 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
seeking to identify risk factors leading to mortality in obstructed left cancer colon
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stoma
Arm Type
Active Comparator
Arm Title
Resection and stoma
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Resection
Intervention Description
Left hemicolectomy
Intervention Type
Procedure
Intervention Name(s)
Stoma
Intervention Description
Colostomy
Primary Outcome Measure Information:
Title
Risk Factors for Mortality in cases of obstructed left colonic Carcinoma
Description
Predictors of mortality after surgery
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged above 18 years admitted at Mansoura University Hospitals complaining from intestinal obstruction due to obstructed left sided carcinoma.
Exclusion Criteria:
Treatment with non-surgical intervention or spontaneous relief of obstruction
Facility Information:
Facility Name
Mansoura University
City
Mansourah
State/Province
Eldakahlia
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
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