Clinical Trials Directory

Trials / Completed

CompletedNCT03302598

Assessment of Relation Between Recurrence of Enterocutaneous Fistula and Preoperative C-reactive Protein Level After Complete Surgical Repair

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Zagazig University · Other Government
Sex
All
Age
56 Years – 77 Years
Healthy volunteers
Accepted

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.

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTserum C-reactive protein

Timeline

Start date
2015-01-20
Primary completion
2017-01-20
Completion
2017-04-15
First posted
2017-10-05
Last updated
2017-10-06

Source: ClinicalTrials.gov record NCT03302598. Inclusion in this directory is not an endorsement.