Colorectal CancerNCT06074432
Risk Factors Associated With Morbidity and Mortality in Emergency Colorectal Cancer Resections
An observational study of Colorectal Cancer, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. 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?
- Emergency Colorectal Resection
- How many people
- 191 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2023to 30 Aug 2023
- 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 who underwent emergency colorectal resection between January 2019 and December 2022
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırkoy Dr.Sadi Konuk Training and Research Hospital
Istanbul
About this study
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.
Read the detailed description
Patients who underwent emergency colorectal resection in a single tertiary referral center between January 2019 and December 2022 were planned to include. 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: patients underwent surgery without resection, 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.
Surgical procedures were performed by general surgeons and only some of them had a subspecialisation in colorectal surgery.
Factors such as age, sex, body mass index (BMI), ASA score, Charlson comorbidity index, smoking status and comorbidity histories, existence of perioperative blood transfusions, duration of surgery, length of hospital stay, tumor side and characteristics, presence of perforation and ascites of the cases were noted. Patients were divided into two subgroups in terms of ASA scores. ASA I and II patients were the first subgroup and ASA III and IV were the other subgroup. A tumor located distal to the midpoint of the transverse colon was accepted as left sided and the others as proximal right sided.
Nutritional risk screening (NRS 2002) scores of the patients were also included in the analyzes. NRS 2002 scores were recorded at hospital admission. Patients were divided into two subgroups as being at nutritional risk (score 3 or more) or not (score less than 3) according to the total score recorded. For the presence of morbidity, a Clavien-Dindo score of 3 and more complications were taken as basis. Mortality was defined as the death within 90 days of operation.
Risk factors for both morbidity and mortality were first evaluated using univariate analyzes. Factors detected as significantly related to morbidity and mortality in appropriate univariate analyzes were included in multivariate analyzes with logistic regression. Multivariate analyzes done for both morbidity and mortality. The effects of risk factors on morbidity and mortality were expressed as the relative risk (odds ratio) with their 95% confidence intervals. Statistical significance level was set at 0.05
- Conditions
- Colorectal Cancer
- Being tested
- Emergency Colorectal Resection
- Keywords
- Emergency Treatment, Colorectal Cancer, Mortality, Morbidity, Risk Factors
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Colorectal ResectionOther
Patients underwent resection due to colorectal carcinoma in emergency surgery
| Study group | Role | What they receive |
|---|---|---|
| Emergency Colorectal Cancer Resection | Patients that underwent emergent resection because of histopathologically confirmed colorectal carcinoma Receives: Other: Emergency Colorectal Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Patients developed a major complication that has a Clavien-Dindo Score ≥3
Measured: Until postoperative 90 days
Mortality
Patients died in the postoperative period within 90 days
Measured: Until postoperative 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start25 Jul 2023
- Primary completion10 Aug 2023
- Study completion30 Aug 2023
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Turgut Donmez, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Mehmet Karabulut, Study chair, University of Health Sciences, Bakirkoy Dr.Sadi Konuk Training and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074432
- Sponsor's protocol ID
- Emer. CRC Mort Risk Factors
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Associated With Morbidity and Mortality in Emergency Colorectal Cancer Resections
- ClinicalTrials.gov ID
- NCT06074432
- Acronym / sponsor ID
- Emer. CRC Mort Risk Factors
- Conditions
- Colorectal Cancer
- Keywords
- Emergency Treatment, Colorectal Cancer, Mortality, Morbidity, Risk Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 10 Oct 2023 (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.
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.
Detailed description
Patients who underwent emergency colorectal resection in a single tertiary referral center between January 2019 and December 2022 were planned to include. 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: patients underwent surgery without resection, 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.
Surgical procedures were performed by general surgeons and only some of them had a subspecialisation in colorectal surgery.
Factors such as age, sex, body mass index (BMI), ASA score, Charlson comorbidity index, smoking status and comorbidity histories, existence of perioperative blood transfusions, duration of surgery, length of hospital stay, tumor side and characteristics, presence of perforation and ascites of the cases were noted. Patients were divided into two subgroups in terms of ASA scores. ASA I and II patients were the first subgroup and ASA III and IV were the other subgroup. A tumor located distal to the midpoint of the transverse colon was accepted as left sided and the others as proximal right sided.
Nutritional risk screening (NRS 2002) scores of the patients were also included in the analyzes. NRS 2002 scores were recorded at hospital admission. Patients were divided into two subgroups as being at nutritional risk (score 3 or more) or not (score less than 3) according to the total score recorded. For the presence of morbidity, a Clavien-Dindo score of 3 and more complications were taken as basis. Mortality was defined as the death within 90 days of operation.
Risk factors for both morbidity and mortality were first evaluated using univariate analyzes. Factors detected as significantly related to morbidity and mortality in appropriate univariate analyzes were included in multivariate analyzes with logistic regression. Multivariate analyzes done for both morbidity and mortality. The effects of risk factors on morbidity and mortality were expressed as the relative risk (odds ratio) with their 95% confidence intervals. Statistical significance level was set at 0.05
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Colorectal Cancer Resection | – | Other: Emergency Colorectal ResectionPatients that underwent emergent resection because of histopathologically confirmed colorectal carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent emergency colorectal resection between January 2019 and December 2022
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Emergency Colorectal ResectionPatients underwent resection due to colorectal carcinoma in emergency surgery | Other | Emergency Colorectal Cancer Resection |
Primary outcome
Morbidity
Time frame: Until postoperative 90 days
Patients developed a major complication that has a Clavien-Dindo Score ≥3
Mortality
Time frame: Until postoperative 90 days
Patients died in the postoperative period within 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 10 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Mehmet Karabulut study chair
University of Health Sciences, Bakirkoy Dr.Sadi Konuk Training and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 2 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 10 Oct 2023. 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 Turkey (Türkiye). 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?
Morbidity (time frame: Until postoperative 90 days). 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 10 Oct 2023.