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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03302598
Enrollment
40
Registered
2017-10-05
Start date
2015-01-20
Completion date
2017-04-15
Last updated
2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enterocutaneous Fistula

Keywords

enterocutaneous fistula - C-reactive protein- surgical repair

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.

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.

Interventions

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
56 Years to 77 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.2 yearsthe 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026