NCT04422106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

June 17, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 19, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

June 3, 2020

Last Update Submit

June 17, 2020

Conditions

Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Predictors of intestinal anastomosis leakage, application of new predictors and new scoresDIAGNOSTIC_TEST

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient with intestinal or colonic anastomosis either elective or emergent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed Arnouse

CONTACT

01099222561drmhamdy@mans.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 9, 2020

Study Start

June 17, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 19, 2020

Record last verified: 2020-05

Locations

EG(1)