Risk Factors for Mortality in Cases of Obstructed Left Colonic CarcinomaNCT04823416
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
A study testing Resection and Stoma in people with Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma, run by Mansoura University at 1 site in Egypt.
Trial summary
seeking to identify risk factors leading to mortality in obstructed left cancer colon Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
- What is being tested?
- Resection and Stoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 20 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged above 18 years admitted at Mansoura University Hospitals complaining from intestinal obstruction due to obstructed left sided carcinoma.
Who cannot join
- Treatment with non-surgical intervention or spontaneous relief of obstruction
Trial locations and contacts
1 site in 1 country.
About this study
seeking to identify risk factors leading to mortality in obstructed left cancer colon
- Being tested
- Resection, Stoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResectionProcedure or surgery
Left hemicolectomy
StomaProcedure or surgery
Colostomy
| Study group | Role | What they receive |
|---|---|---|
| Stoma | Active comparator | Not described Receives: Procedure: Stoma |
| Resection and stoma | Active comparator | Not described Receives: Procedure: Resection; Procedure: Stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Factors for Mortality in cases of obstructed left colonic Carcinoma
Predictors of mortality after surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Jan 2019
- Primary completion1 Jun 2020
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors for Mortality in Cases of Obstructed Left Colonic CarcinomaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823416
- Sponsor's protocol ID
- MD.19.04.169.R1-2019/06/27
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
- ClinicalTrials.gov ID
- NCT04823416
- Acronym / sponsor ID
- MD.19.04.169.R1-2019/06/27
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
seeking to identify risk factors leading to mortality in obstructed left cancer colon
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stoma | Active comparator | Procedure: Stoma |
| Resection and stoma | Active comparator | Procedure: Resection, Procedure: Stoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient aged above 18 years admitted at Mansoura University Hospitals complaining from intestinal obstruction due to obstructed left sided carcinoma.
Key exclusion criteria (1 listed)
- Treatment with non-surgical intervention or spontaneous relief of obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResectionLeft hemicolectomy | Procedure or surgery | Resection and stoma |
| StomaColostomy | Procedure or surgery | Resection and stoma, Stoma |
Primary outcome
Risk Factors for Mortality in cases of obstructed left colonic Carcinoma
Time frame: 30 days after surgery
Predictors of mortality after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resection and Stoma in people with Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Factors for Mortality in cases of obstructed left colonic Carcinoma (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.