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

NCT ID: NCT03302598

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-20

Study Completion Date

2017-04-15

Brief Summary

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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

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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

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Enterocutaneous Fistula

Keywords

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enterocutaneous fistula - C-reactive protein- surgical repair

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients with enterocutaneous fistula

Group Type OTHER

serum C-reactive protein

Intervention Type DIAGNOSTIC_TEST

Interventions

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serum C-reactive protein

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with ECF were included in the study

Exclusion Criteria

* Cases submitted for surgical treatment with protecting stoma or terminal were excluded from our study. Other fistulas like perianal, pancreatic, biliary and internal fistulas were not involved due to their different nature, treatment and prognosis
Minimum Eligible Age

56 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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osama khalil

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IR-12758-2

Identifier Type: -

Identifier Source: org_study_id