Colorectal CancerNCT06437691
Effect of Stent Placement on Short Term Survival of Left Sided Obstructive Colorectal Cancers
An observational study of Colorectal Cancer, run by Yasir Musa Kesgin, MD.
Trial summary
The aim of this observational study is to determine effect of stent placement on survival results in first three years in a patient who applied to the emergency department with obstruction due to colorectal cancer. Eligible patients divided into two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Self-Expandable Metallic Stent Placement
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 20 Feb 2024
- Phase
- Observational
- 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
Study population: Patients come to emergency department and diagnosed as left sided obstructive colorectal cancer
Who may be able to join
- All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms and diagnosed as left sided (descending colon, sigmoid colon and upper rectum) obstructive colorectal cancer were included
Who cannot join
- Who underwent emergency surgery due to unsuccessful stent placement intervention
- Who underwent emergency surgery due to stent-related complications
- Those with middle and lower rectum tumors
- Those received neoadjuvant treatment,
- Patients have perforation,
- Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.),
- Who has a recurrent disease or metastasis.
About this study
Official title: Effect of Stent Placement on Short Term Survival of Left Sided Obstructive Colorectal Cancers. Comparison of Bridge-To-Surgery Versus Emergency Surgery Approaches
The aim of this observational study is to determine effect of stent placement on survival results in first three years in a patient who applied to the emergency department with obstruction due to colorectal cancer. Eligible patients divided into two groups. Group A includes patients underwent emergency surgery directly. Patients underwent elective surgery following stent placement as bridge-to-surgery. Patients underwent elective surgery following bridge-to-surgery stent placement were accepted as Group B.
Read the detailed description
Patients who applied to emergency department of a single tertiary referral center between January 2016 and December 2020 and diagnosed as left sided obstructive colorectal cancer were included in this retrospective study. All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms.
Patients were excluded from the analysis if they met any of the following criteria:
- Who underwent emergency surgery due to unsuccessful stent application intervention or stent-related complications developed,
- Those with middle and lower rectum tumors or received neoadjuvant treatment,
- Perforation,
- Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.),
- Recurrent disease patients
- Patients have metastasis
- Conditions
- Colorectal Cancer
- Being tested
- Self-Expandable Metallic Stent Placement
- Keywords
- Obstruction, Bridge To Surgery
- Medical subject headings
- Colorectal Neoplasms, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Expandable Metallic Stent PlacementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A - Emergency Surgery Group | Patients underwent emergency surgery directly after coming to emergency department due to left sided obstructive colorectal cancer | |
| Group B - Stent Group | Left sided obstructive colorectal cancer patients underwent elective surgery following decompression via self-expandable metallic stent placement. Receives: Procedure: Self-Expandable Metallic Stent Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
The survival time of patient after being diagnosed as colorectal cancer after coming to emergency department
Measured: 3 years
Disease Free Survival
The local or systemic recurrence free time period of patient after being diagnosed as colorectal cancer after coming to emergency department
Measured: 3 years
Secondary outcomes (4)
Mortality
Death of patient in postoperative first three months
Measured: 90 days
Serious complications
Postoperative complications of patients that have a Clavien-Dindo Score greater than or equal to 3
Measured: 90 days
Minimally invasive surgery
Patients that found a chance for fully minimally invasive surgery for resection of colorectal cancer
Measured: 90 days
End colostomy rate
Patients that have a end colostomy at the end of surgical resection of colorectal cancer
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jan 2016
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasir Musa Kesgin, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasir Musa Kesgin, MD, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Ahmet Sürek, Study chair, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437691
- Sponsor's protocol ID
- StentSurv
- Status last verified
- Aug 2024
- First submitted
- 25 May 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analysed during the current study are not publicly available due to institutional policies but are available from the contact person on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stent Placement on Short Term Survival of Left Sided Obstructive Colorectal Cancers. Comparison of Bridge-To-Surgery Versus Emergency Surgery Approaches
- ClinicalTrials.gov ID
- NCT06437691
- Acronym / sponsor ID
- StentSurv
- Conditions
- Colorectal Cancer
- Keywords
- Obstruction, Bridge To Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Yasir Musa Kesgin, MDUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 31 May 2024 (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.
The aim of this observational study is to determine effect of stent placement on survival results in first three years in a patient who applied to the emergency department with obstruction due to colorectal cancer. Eligible patients divided into two groups. Group A includes patients underwent emergency surgery directly. Patients underwent elective surgery following stent placement as bridge-to-surgery. Patients underwent elective surgery following bridge-to-surgery stent placement were accepted as Group B.
Detailed description
Patients who applied to emergency department of a single tertiary referral center between January 2016 and December 2020 and diagnosed as left sided obstructive colorectal cancer were included in this retrospective study. All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms.
Patients were excluded from the analysis if they met any of the following criteria:
- Who underwent emergency surgery due to unsuccessful stent application intervention or stent-related complications developed,
- Those with middle and lower rectum tumors or received neoadjuvant treatment,
- Perforation,
- Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.),
- Recurrent disease patients
- Patients have metastasis
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Emergency Surgery Group | – | –Patients underwent emergency surgery directly after coming to emergency department due to left sided obstructive colorectal cancer |
| Group B - Stent Group | – | Procedure: Self-Expandable Metallic Stent PlacementLeft sided obstructive colorectal cancer patients underwent elective surgery following decompression via self-expandable metallic stent placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients come to emergency department and diagnosed as left sided obstructive colorectal cancer
Key inclusion criteria (1 listed)
- All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms and diagnosed as left sided (descending colon, sigmoid colon and upper rectum) obstructive colorectal cancer were included
Key exclusion criteria (7 listed)
- Who underwent emergency surgery due to unsuccessful stent placement intervention
- Who underwent emergency surgery due to stent-related complications
- Those with middle and lower rectum tumors
- Those received neoadjuvant treatment,
- Patients have perforation,
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 |
|---|---|---|
| Self-Expandable Metallic Stent Placement | Procedure or surgery | Group B - Stent Group |
Primary outcome
Overall Survival
Time frame: 3 years
The survival time of patient after being diagnosed as colorectal cancer after coming to emergency department
Disease Free Survival
Time frame: 3 years
The local or systemic recurrence free time period of patient after being diagnosed as colorectal cancer after coming to emergency department
4 secondary outcomes
Mortality
Time frame: 90 days
Serious complications
Time frame: 90 days
Minimally invasive surgery
Time frame: 90 days
End colostomy rate
Time frame: 90 days
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 20 Aug 2024.
- Individual participant dataSharing planned: No. The datasets generated and analysed during the current study are not publicly available due to institutional policies but are available from the contact person on reasonable request.
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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.
Ahmet Sürek study chair
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Yasir Musa Kesgin, MD.
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 7 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall Survival (time frame: 3 years). The study lists 2 primary outcomes in all. 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 20 Aug 2024.