Anastomotic LeakNCT05159024
Role of Procalcitonin, C-Reactive Protein, and WBC Count in Prediction of Colorectal Anastomotic Leak
An observational study of Anastomotic Leak, run by Suez Canal University at 1 site in Egypt.
Trial summary
The interest in identifying a biological marker for the early detection of AL is growing. Such a marker could play a vital role in modern fast-track multimodal protocols, allowing safe and early discharge of patients after colorectal surgery with a low rate of readmission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak
- What is being tested?
- CRP, PCT, and WBCs trajectories
- How many people
- 205 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 30 Apr 2020
- 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
- Adult, Older adult
Study population: 205 patients who had colorectal surgery, all patients had a diagnosis of new or previous colorectal cancer. 56.1% of patients were males and 43.9% were females. Patient age ranged from 25 to 78 years, with a mean of 56.4 years
Who may be able to join
- adult patients of either sex who underwent colorectal surgery entailing an anastomosis
Who cannot join
- Patients younger than 18 years
- Patients with active infection at the time of surgery
- Patients who had received chemotherapy or radiotherapy
- Patients on long-term corticosteroid therapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: A Prospective Cohort Study on the Role of The Triad of Procalcitonin, C-Reactive Protein, and White Blood Cell Count in The Prediction of Anastomotic Leak Following Colorectal Resections
The interest in identifying a biological marker for the early detection of AL is growing. Such a marker could play a vital role in modern fast-track multimodal protocols, allowing safe and early discharge of patients after colorectal surgery with a low rate of readmission. C-reactive protein (CRP) has been identified as a valid parameter for detection of postoperative infectious complications after rectal resection. A serum CRP level greater than 12.4 mg/dL on postoperative day (POD) 4 is considered predictive of septic complications. According to a recent analysis, the changes in the trajectory of CRP levels might be more beneficial than a snipped point. Moreover, the trajectory has a negative predictability of up to 99.3%. Another interesting biomarker is procalcitonin (PCT), the prohormone of calcitonin, produced by parafollicular C cells in the thyroid. Normally, it has a very low plasma concentration in healthy individuals (0.01-0.05 ng/mL), and it increases during severe generalized bacterial, parasitic, or fungal infections, but not in noninfectious inflammatory reactions. Procalcitonin has been described as an early, sensitive, and specific marker of sepsis. Moreover, the plasma concentration of PCT has been used as an early predictor of infection in acute pancreatitis, secondary peritonitis, and infectious complications after thoracic, esophageal, and cardiac surgeries. In addition, elevated white blood cell (WBC) count is associated with AL after gastrointestinal surgeries. Therefore, this study was conducted to evaluate the utility of CRP, PCT, and WBC count trajectories, as separate and combined biomarkers for prediction of AL after colorectal surgery.
- Conditions
- Anastomotic Leak
- Being tested
- CRP, PCT, and WBCs trajectories
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP, PCT, and WBCs trajectoriesDiagnostic test
the levels of CRP, PCT, and WBCs were assessed before surgery and after the onset of leak
| Study group | Role | What they receive |
|---|---|---|
| Patients with leak after colorectal anastomosis | Patients who developed anastomotic leak, clinical or radiologic, after colorectal resection and anastomosis Receives: Diagnostic Test: CRP, PCT, and WBCs trajectories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of combined CRP-PCT- WBC trajectory in prediction of anastomotic leak
Sensitivity, specificity and accuracy of combined CRP-PCT- WBCs trajectory
Measured: five 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 posted15 Dec 2021
- Study start1 Mar 2018
- Primary completion1 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Waleed Ghareeb, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159024
- Sponsor's protocol ID
- Trajectory2021
- Status last verified
- Jul 2024
- First submitted
- 18 Nov 2021
- Last updated
- 26 Jul 2024
- 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 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on the Role of The Triad of Procalcitonin, C-Reactive Protein, and White Blood Cell Count in The Prediction of Anastomotic Leak Following Colorectal Resections
- ClinicalTrials.gov ID
- NCT05159024
- Acronym / sponsor ID
- Trajectory2021
- Conditions
- Anastomotic Leak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 15 Dec 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.
The interest in identifying a biological marker for the early detection of AL is growing. Such a marker could play a vital role in modern fast-track multimodal protocols, allowing safe and early discharge of patients after colorectal surgery with a low rate of readmission. C-reactive protein (CRP) has been identified as a valid parameter for detection of postoperative infectious complications after rectal resection. A serum CRP level greater than 12.4 mg/dL on postoperative day (POD) 4 is considered predictive of septic complications. According to a recent analysis, the changes in the trajectory of CRP levels might be more beneficial than a snipped point. Moreover, the trajectory has a negative predictability of up to 99.3%. Another interesting biomarker is procalcitonin (PCT), the prohormone of calcitonin, produced by parafollicular C cells in the thyroid. Normally, it has a very low plasma concentration in healthy individuals (0.01-0.05 ng/mL), and it increases during severe generalized bacterial, parasitic, or fungal infections, but not in noninfectious inflammatory reactions. Procalcitonin has been described as an early, sensitive, and specific marker of sepsis. Moreover, the plasma concentration of PCT has been used as an early predictor of infection in acute pancreatitis, secondary peritonitis, and infectious complications after thoracic, esophageal, and cardiac surgeries. In addition, elevated white blood cell (WBC) count is associated with AL after gastrointestinal surgeries. Therefore, this study was conducted to evaluate the utility of CRP, PCT, and WBC count trajectories, as separate and combined biomarkers for prediction of AL after colorectal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with leak after colorectal anastomosis | – | Diagnostic Test: CRP, PCT, and WBCs trajectoriesPatients who developed anastomotic leak, clinical or radiologic, after colorectal resection and anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 205 patients who had colorectal surgery, all patients had a diagnosis of new or previous colorectal cancer. 56.1% of patients were males and 43.9% were females. Patient age ranged from 25 to 78 years, with a mean of 56.4 years
Key inclusion criteria (1 listed)
- adult patients of either sex who underwent colorectal surgery entailing an anastomosis
Key exclusion criteria (4 listed)
- Patients younger than 18 years
- Patients with active infection at the time of surgery
- Patients who had received chemotherapy or radiotherapy
- Patients on long-term corticosteroid therapy.
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 |
|---|---|---|
| CRP, PCT, and WBCs trajectoriesthe levels of CRP, PCT, and WBCs were assessed before surgery and after the onset of leak | Diagnostic test | Patients with leak after colorectal anastomosis |
Primary outcome
Diagnostic accuracy of combined CRP-PCT- WBC trajectory in prediction of anastomotic leak
Time frame: five days after surgery
Sensitivity, specificity and accuracy of combined CRP-PCT- WBCs trajectory
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 26 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Anastomotic Leak
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Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
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 Anastomotic Leak, run by Suez Canal 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 4 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 26 Jul 2024. 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?
Diagnostic accuracy of combined CRP-PCT- WBC trajectory in prediction of anastomotic leak (time frame: five 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 26 Jul 2024.