Investigating the Role of EN in NTIS Among Fistula Patients

NCT ID: NCT02038504

Last Updated: 2014-06-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Fistula

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

gastrointestinal fistula enteral nutrition thyroid function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

gastrointestinal fistula

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianan Ren

VIce-president of General Surgery, Jinling Hospital, Professor of Medical School of Nanjing University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of General Surgery, Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

81270478

Identifier Type: OTHER

Identifier Source: secondary_id

NTIS-EN-1

Identifier Type: -

Identifier Source: org_study_id