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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
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 29, 2021
Last Updated
March 29, 2021
Sponsor
Mansoura University
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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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