Back to resultsPredictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores
Primary Purpose
Anastomotic Leak
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Predictors of intestinal anastomosis leakage, application of new predictors and new scores
Sponsored by
About this trial
This is an interventional diagnostic trial for Anastomotic Leak
Eligibility Criteria
Inclusion Criteria:
- Any patient with intestinal or colonic anastomosis either elective or emergent.
Exclusion Criteria:
- Patients with inflammatory bowel disease will be excluded because this could influence plasma levels of inflammatory biomarkers.
- patients using corticosteroids
- Patients unfit for anaesthesia, those having collagen diseases or hematological disorders.
Sites / Locations
- Mansoura UniversityRecruiting
Outcomes
Primary Outcome Measures
Early detection and management of intestinal anastomotic leak
Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leak(Intestinal fatty acid binding protein, Procalcitonin and CRP) with application of scoring scale(Dekker et al 2011) (Dulk et al ., 2013) to assess presence or absence of leakage.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04422106
Brief Title
Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores
Official Title
Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Aim of the work This study aims at; Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leakage with application of scoring scale to assess presence or absence of leakage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Predictors of intestinal anastomosis leakage, application of new predictors and new scores
Intervention Description
Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leakage with application of scoring scale to assess presence or absence of leakage.
Primary Outcome Measure Information:
Title
Early detection and management of intestinal anastomotic leak
Description
Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leak(Intestinal fatty acid binding protein, Procalcitonin and CRP) with application of scoring scale(Dekker et al 2011) (Dulk et al ., 2013) to assess presence or absence of leakage.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient with intestinal or colonic anastomosis either elective or emergent.
Exclusion Criteria:
Patients with inflammatory bowel disease will be excluded because this could influence plasma levels of inflammatory biomarkers.
patients using corticosteroids
Patients unfit for anaesthesia, those having collagen diseases or hematological disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Arnouse
Phone
01099222561
Email
drmhamdy@mans.edu.eg
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Hamada Mohamed Hamada
Phone
+20 109 212 7930
Email
irb.mfm@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores
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