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

NCT03302598 | Completed

• 1 other identifier: IR-12758-2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Enterocutaneous Fistula

Keywords

enterocutaneous fistula - C-reactive protein- surgical repair

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients with enterocutaneous fistula

OTHER

Diagnostic Test: serum C-reactive protein

Interventions

serum C-reactive protein DIAGNOSTIC_TEST

patients with enterocutaneous fistula

Eligibility Criteria

• Age: 56 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with ECF were included in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Intestinal Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2017
• First Posted: October 5, 2017
• Study Start: January 20, 2015
• Primary Completion: January 20, 2017
• Study Completion: April 15, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10