<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03302598</url>
  </required_header>
  <id_info>
    <org_study_id>IR-12758-2</org_study_id>
    <nct_id>NCT03302598</nct_id>
  </id_info>
  <brief_title>Assessment of Relation Between Recurrence of Enterocutaneous Fistula and Preoperative C-reactive Protein Level After Complete Surgical Repair</brief_title>
  <official_title>Assessment of Relation Between Recurrence of Enterocutaneous Fistula and Preoperative C-reactive Protein Level After Complete Surgical Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <brief_summary>
    <textblock>
      A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and&#xD;
      prepared for definite surgical repair in the form of resection anastomosis of ECF. The&#xD;
      investigators used preoperative serum C-reactive protein as predicting factor to recurrence&#xD;
      and independent variable for timing of surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a controversy in timing of operation. The timing depends on clinical assessment,&#xD;
      laboratory tests and radiological investigations. The cornerstone of this decision is to&#xD;
      control sepsis and inflammatory condition before surgery. This issue made surgeons favor&#xD;
      longer interval between incidence of ECF and definite surgical treatment. In some cases there&#xD;
      may be a hidden place for infection or continuation of the inflammatory situation without&#xD;
      clear signs, which necessitated the presence of a possible indicator helps in making the&#xD;
      surgical decision. Serum C-reactive protein is the common inflammatory marker used to exclude&#xD;
      inflammatory condition. Although its level is within normal range but some cases showed high&#xD;
      recurrence rate when the level exceeded certain as the investigators believed in their study.&#xD;
      Now the investigators can say that the perioperative serum C-reactive protein level can be&#xD;
      used as an objective parameter for helping to make surgical decision and reduce recurrence of&#xD;
      ECF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2015</start_date>
  <completion_date type="Actual">April 15, 2017</completion_date>
  <primary_completion_date type="Actual">January 20, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <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.</measure>
    <time_frame>2 years</time_frame>
    <description>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</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Enterocutaneous Fistula</condition>
  <arm_group>
    <arm_group_label>patients with enterocutaneous fistula</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum C-reactive protein</intervention_name>
    <arm_group_label>patients with enterocutaneous fistula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with ECF were included in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cases submitted for surgical treatment with protecting stoma or terminal were excluded&#xD;
             from our study. Other fistulas like perianal, pancreatic, biliary and internal&#xD;
             fistulas were not involved due to their different nature, treatment and prognosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>56 Years</minimum_age>
    <maximum_age>77 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>osama khalil</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>enterocutaneous fistula - C-reactive protein- surgical repair</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Fistula</mesh_term>
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03302598
org study id: IR-12758-2
nct id: NCT03302598
lead sponsor: 
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention 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.
primary purpose: Treatment
masking: None (Open Label)
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
description: 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
arm group label: patients with enterocutaneous fistula
arm group type: Other
intervention type: Diagnostic Test
intervention name: serum C-reactive protein
arm group label: patients with enterocutaneous fistula
criteria: 
gender: All
minimum age: 56 Years
maximum age: 77 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: osama khalil
investigator title: assistant professor
mesh term: Intestinal Fistula
mesh term: Recurrence
mesh term: Fistula
sharing ipd: Undecided