Enterocutaneous FistulaNCT03302598
Assessment of Relation Between Recurrence of Enterocutaneous Fistula and Preoperative C-reactive Protein Level After Complete Surgical Repair
A study testing serum C-reactive protein in people with Enterocutaneous Fistula, run by Zagazig University.
Trial summary
A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and prepared for definite surgical repair in the form of resection anastomosis of ECF. The investigators used preoperative serum C-reactive protein as predicting factor to recurrence and independent variable for timing of surgery. Read more about this study
- Who is it for?
- Ages 56 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Enterocutaneous Fistula
- What is being tested?
- serum C-reactive protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2015to 15 Apr 2017
- 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 56 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with ECF were included in the study
Who cannot join
- Cases submitted for surgical treatment with protecting stoma or terminal were excluded from our study. Other fistulas like perianal, pancreatic, biliary and internal fistulas were not involved due to their different nature, treatment and prognosis
About this study
A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and prepared for definite surgical repair in the form of resection anastomosis of ECF. The investigators used preoperative serum C-reactive protein as predicting factor to recurrence and independent variable for timing of surgery.
Read the detailed description
There is a controversy in timing of operation. The timing depends on clinical assessment, laboratory tests and radiological investigations. The cornerstone of this decision is to control sepsis and inflammatory condition before surgery. This issue made surgeons favor longer interval between incidence of ECF and definite surgical treatment. In some cases there may be a hidden place for infection or continuation of the inflammatory situation without clear signs, which necessitated the presence of a possible indicator helps in making the surgical decision. Serum C-reactive protein is the common inflammatory marker used to exclude inflammatory condition. Although its level is within normal range but some cases showed high recurrence rate when the level exceeded certain as the investigators believed in their study. Now the investigators can say that the perioperative serum C-reactive protein level can be used as an objective parameter for helping to make surgical decision and reduce recurrence of ECF.
- Conditions
- Enterocutaneous Fistula
- Being tested
- serum C-reactive protein
- Keywords
- enterocutaneous fistula - C-reactive protein- surgical repair
- Medical subject headings
- Intestinal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum C-reactive proteinDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| patients with enterocutaneous fistula | Other | Not described Receives: Diagnostic Test: serum C-reactive protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein can be used as predicting factor for recurrence of ECF after definite surgical treatment as well as helping surgeon to take decision for proper time of operation.
the investigator will measure the preoperative C-reactive protein in cases of ECF which are scheduled for operative treatment . The level of c-reactive protein will be measured in the postoperative recurrent cases . we aim to find a relation between perioperative level of C-reactive protein and recurrence of ECF so it can help surgeon to choose proper time for surgical treatment to avoid recurrence of ECF
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start20 Jan 2015
- Primary completion20 Jan 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterocutaneous FistulaStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and prepared for definite surgical repair in the form of resection anastomosis of ECF. the investigators used preoperative serum C-reactive protein as predicting factor to recurrence and independent variable for timing of surgery.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, osama khalil, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302598
- Sponsor's protocol ID
- IR-12758-2
- Status last verified
- Oct 2017
- First submitted
- 24 Sep 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Relation Between Recurrence of Enterocutaneous Fistula and Preoperative C-reactive Protein Level After Complete Surgical Repair
- ClinicalTrials.gov ID
- NCT03302598
- Acronym / sponsor ID
- IR-12758-2
- Conditions
- Enterocutaneous Fistula
- Keywords
- enterocutaneous fistula - C-reactive protein- surgical repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 5 Oct 2017 (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.
A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and prepared for definite surgical repair in the form of resection anastomosis of ECF. The investigators used preoperative serum C-reactive protein as predicting factor to recurrence and independent variable for timing of surgery.
Detailed description
There is a controversy in timing of operation. The timing depends on clinical assessment, laboratory tests and radiological investigations. The cornerstone of this decision is to control sepsis and inflammatory condition before surgery. This issue made surgeons favor longer interval between incidence of ECF and definite surgical treatment. In some cases there may be a hidden place for infection or continuation of the inflammatory situation without clear signs, which necessitated the presence of a possible indicator helps in making the surgical decision. Serum C-reactive protein is the common inflammatory marker used to exclude inflammatory condition. Although its level is within normal range but some cases showed high recurrence rate when the level exceeded certain as the investigators believed in their study. Now the investigators can say that the perioperative serum C-reactive protein level can be used as an objective parameter for helping to make surgical decision and reduce recurrence of ECF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and prepared for definite surgical repair in the form of resection anastomosis of ECF. the investigators used preoperative serum C-reactive protein as predicting factor to recurrence and independent variable for timing of surgery.
| Arm | Type | Receives |
|---|---|---|
| patients with enterocutaneous fistula | Other | Diagnostic Test: serum C-reactive protein |
Who may qualify
- Ages
- 56 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with ECF were included in the study
Key exclusion criteria (1 listed)
- Cases submitted for surgical treatment with protecting stoma or terminal were excluded from our study. Other fistulas like perianal, pancreatic, biliary and internal fistulas were not involved due to their different nature, treatment and prognosis
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 |
|---|---|---|
| serum C-reactive protein | Diagnostic test | patients with enterocutaneous fistula |
Primary outcome
C-reactive protein can be used as predicting factor for recurrence of ECF after definite surgical treatment as well as helping surgeon to take decision for proper time of operation.
Time frame: 2 years
the investigator will measure the preoperative C-reactive protein in cases of ECF which are scheduled for operative treatment . The level of c-reactive protein will be measured in the postoperative recurrent cases . we aim to find a relation between perioperative level of C-reactive protein and recurrence of ECF so it can help surgeon to choose proper time for surgical treatment to avoid recurrence of ECF
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 6 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing serum C-reactive protein in people with Enterocutaneous Fistula, run by Zagazig University.
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 6 Oct 2017. 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?
C-reactive protein can be used as predicting factor for recurrence of ECF after definite surgical treatment as well as helping surgeon to take decision for proper time of operation. (time frame: 2 years). 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 6 Oct 2017.