Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores

Anastomotic Leak Clinical Trial

Official title:

Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04422106
• Other study ID #: MD.19.10.239 - 2019/10/08
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2020
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Mansoura University
• Contact: Mohamed Arnouse
• Phone: 01099222561
• Email: drmhamdy[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak

Intervention

Diagnostic Test:
• Predictors of intestinal anastomosis leakage, application of new predictors and new scores
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.

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months