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

Enterocutaneous Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302598
• Other study ID #: IR-12758-2
• Status: Completed
• Phase: N/A
• First received: September 24, 2017
• Last updated: October 4, 2017
• Start date: January 20, 2015
• Est. completion date: April 15, 2017

Study information

• Verified date: October 2017
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 15, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 56 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Enterocutaneous Fistula
• Fistula
• Intestinal Fistula
• Recurrence

Intervention

Diagnostic Test:
• serum C-reactive protein

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive protein can be used as predicting factor for recurrence of ECF after definite surgical treatment as well as helping surgeon to take decision for proper time of operation.	the investigator will measure the preoperative C-reactive protein in cases of ECF which are scheduled for operative treatment . The level of c-reactive protein will be measured in the postoperative recurrent cases . we aim to find a relation between perioperative level of C-reactive protein and recurrence of ECF so it can help surgeon to choose proper time for surgical treatment to avoid recurrence of ECF	2 years