Investigating the Role of EN in NTIS Among Fistula Patients

Completed

• Conditions: Gastrointestinal Fistula

• Registration Number: NCT02038504
• Lead Sponsor: Jinling Hospital, China

Brief Summary

The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Detailed Description

Nonthyroidal illness syndrome (NTIS) is a common alterations in thyroid function observed in about 70% of hospitalized patients, with or without acute systemic illnesses. Mechanisms in the pathogenesis of NTIS are not yet well understood. Our previous study demonstrated that NTIS occurred frequently with a prevalence of 57.5% in gastrointestinal fistulas patients. In recent study, it has been shown that early enteral nutrition decreases the duration of hospitalization and mortality in the burn population, indicating a potential role of enteral nutrition in NTIS.In addition, the management of fistula patients requires bundle therapy including Nutrition therapy, especially enteral nutrition.The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-27
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinical diagnosis of gastrointestinal fistula
• Clinical diagnosis of nonthyroidal illness syndrome
• Using enteral nutrition for fistula management

Exclusion Criteria

• patients who were prescribed drug which may affect thyroid function before or in our study
• patients who were diagnosed as primary thyroid disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thyroid function	Changes of thyroid function from baseline at 1 week,2 week, 3 week and 4 week after enrolled.	Thyroid function assessment includes level of free triiodothyronine,total triiodothyronine,free thyroxin,total thyroxin,thyroid stimulating hormone,thyroid stimulating hormone index,and standard thyroid stimulating hormone index

Trial Locations

Locations (1)

Department of General Surgery, Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China