Colorectal CancerNCT04717648
C-Reactive Protein and Sodium in Predicting Anastomotic Leakage
An observational study of Colorectal Cancer, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Anastomotic leakage is serious morbidity that can develop in patients operated on for colorectal cancer and can reach potentially life-threatening dimensions. Many international studies have been conducted to reduce and eliminate this postoperative complication that may have a mortal course. 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?
- Biochemical test
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2014to 1 Feb 2019
- 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: All patients eligible for inclusion criteria
Who may be able to join
- Patients over the age of 18 who were operated due to elective colorectal cancer
- Patients who are known to have no solid organ metastases in preoperative imaging methods and whose perioperative surgery notes support this finding
- Patients with ileocolic, colocolic, colorectal anastomosis during the operation
- Patients whose postoperative 1,3,5th day C- Reactive protein and sodium values were measured
Who cannot join
- Patients under the age of 18
- Emergency operated patients
- Patients on a routine dialysis program due to Chronic renal failure
- Patients with a known diagnosis of liver cirrhosis
- Patients who are irresectable during the operation and therefore have undergone palliative surgery
- Patients whose C- Reactive protein and Sodium values were not measured on the postoperative 1, 3, 5th day
Show all 12Show fewer
- Patients with abdominoperineal resection and no bowel anastomosis during the operation
- Patients who have not undergone ileocolic, colocolic, colorectal or ileorectal anastomosis during the operation.
- Patients found to be metastatic during the operation
- Patients who have undergone additional surgical resection (metastasectomy, etc.) due to solid organ metastasis during the operation
- Patients who have had more than one gastrointestinal anastomosis during the same surgery
- Patients undergoing concurrent hyperthermic intraperitoneal chemotherapy (HIPEC) and / or cytoreductive surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Training and Research Hospital
Izmir, 35180
About this study
Official title: The Effect of Postoperative C-Reactive Protein and Sodium Value on the Early Prediction of Anastomotic Leaks in Patients Operated on for Colorectal Cancer
Anastomotic leakage is serious morbidity that can develop in patients operated on for colorectal cancer and can reach potentially life-threatening dimensions. Many international studies have been conducted to reduce and eliminate this postoperative complication that may have a mortal course. In these studies, preoperative, perioperative and postoperative factors of the patient, operation techniques, structure of the material used in the operation and multiple factors belonging to the surgeon were held responsible. Intraabdominal sepsis secondary to late anastomotic leakage and subsequent multiorgan failure can cost the patient's life. Anastomotic leaks that develop in patients who have been operated for colorectal cancer; In order to detect patients' postoperative clinical findings, laboratory examinations, imaging tests, and to eliminate them before intraabdominal sepsis develops, studies including many different laboratory and imaging methods have been carried out. Although previous studies have shown that there are many laboratory examinations and imaging methods that can predict anastomotic leaks early, they have many advantages over each other in terms of efficiency, sensitivity, specificity, and cost.
The investigators aimed to investigate the effectiveness of C reactive protein and blood sodium value, as well as their superiority, among the tests that can predict postoperative anastomotic leakage, especially in patients who have undergone a single anastomosis following resection for non-metastatic colorectal cancer.
Read the detailed description
- Investigate the effectiveness of postoperative C-reactive protein and sodium values in predicting anastomotic leakage in the early postoperative period in patients who have undergone anastomosis following resection for non-metastatic colorectal cancer, and their superiority to each other.
- Investigate the effectiveness of these laboratory parameters in developing anastomotic leaks according to tumor location and different age subgroups (<45 years, 45-65 years,> 65 years).
- Conditions
- Colorectal Cancer
- Being tested
- Biochemical test
- Keywords
- anastomotic leak, hyponatremia, colorectal carcinoma, c-reactive protein
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical testDiagnostic test
C Reactive protein and sodium
| Study group | Role | What they receive |
|---|---|---|
| Patients with anastomotic leakage | Post operative anastomotic leakage Receives: Diagnostic Test: Biochemical test | |
| Patients without anastomotic leakage | Post operative without anastomotic leakage Receives: Diagnostic Test: Biochemical test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early predictive factors of anastomotic leakege
The anastomotic leak of the measurement The measurement tool is the laboratory parameters.
Measured: 2 or 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jan 2014
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra Demirli Atici, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717648
- Sponsor's protocol ID
- 2020/13-51
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postoperative C-Reactive Protein and Sodium Value on the Early Prediction of Anastomotic Leaks in Patients Operated on for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04717648
- Acronym / sponsor ID
- 2020/13-51
- Conditions
- Colorectal Cancer
- Keywords
- anastomotic leak, hyponatremia, colorectal carcinoma, c-reactive protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 22 Jan 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.
Anastomotic leakage is serious morbidity that can develop in patients operated on for colorectal cancer and can reach potentially life-threatening dimensions. Many international studies have been conducted to reduce and eliminate this postoperative complication that may have a mortal course. In these studies, preoperative, perioperative and postoperative factors of the patient, operation techniques, structure of the material used in the operation and multiple factors belonging to the surgeon were held responsible. Intraabdominal sepsis secondary to late anastomotic leakage and subsequent multiorgan failure can cost the patient's life. Anastomotic leaks that develop in patients who have been operated for colorectal cancer; In order to detect patients' postoperative clinical findings, laboratory examinations, imaging tests, and to eliminate them before intraabdominal sepsis develops, studies including many different laboratory and imaging methods have been carried out. Although previous studies have shown that there are many laboratory examinations and imaging methods that can predict anastomotic leaks early, they have many advantages over each other in terms of efficiency, sensitivity, specificity, and cost.
The investigators aimed to investigate the effectiveness of C reactive protein and blood sodium value, as well as their superiority, among the tests that can predict postoperative anastomotic leakage, especially in patients who have undergone a single anastomosis following resection for non-metastatic colorectal cancer.
Detailed description
- Investigate the effectiveness of postoperative C-reactive protein and sodium values in predicting anastomotic leakage in the early postoperative period in patients who have undergone anastomosis following resection for non-metastatic colorectal cancer, and their superiority to each other.
- Investigate the effectiveness of these laboratory parameters in developing anastomotic leaks according to tumor location and different age subgroups (<45 years, 45-65 years,> 65 years).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with anastomotic leakage | – | Diagnostic Test: Biochemical testPost operative anastomotic leakage |
| Patients without anastomotic leakage | – | Diagnostic Test: Biochemical testPost operative without anastomotic leakage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients eligible for inclusion criteria
Key inclusion criteria (4 listed)
- Patients over the age of 18 who were operated due to elective colorectal cancer
- Patients who are known to have no solid organ metastases in preoperative imaging methods and whose perioperative surgery notes support this finding
- Patients with ileocolic, colocolic, colorectal anastomosis during the operation
- Patients whose postoperative 1,3,5th day C- Reactive protein and sodium values were measured
Key exclusion criteria (12 listed)
- Patients under the age of 18
- Emergency operated patients
- Patients on a routine dialysis program due to Chronic renal failure
- Patients with a known diagnosis of liver cirrhosis
- Patients who are irresectable during the operation and therefore have undergone palliative surgery
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 |
|---|---|---|
| Biochemical testC Reactive protein and sodium | Diagnostic test | Patients with anastomotic leakage, Patients without anastomotic leakage |
Primary outcome
Early predictive factors of anastomotic leakege
Time frame: 2 or 3 days
The anastomotic leak of the measurement The measurement tool is the laboratory parameters.
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 3 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
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?
An observational study of Colorectal Cancer, run by Tepecik Training and Research 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 4 inclusion and 12 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 3 Feb 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 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?
Early predictive factors of anastomotic leakege (time frame: 2 or 3 days). 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 3 Feb 2021.