Evaluation of Esophageal Injuries in Corrosives in Assiut Governorate - Experimental Comparison Between Different Treatments

Esophageal stricture is one of the most common sequelae of caustic injury. Up to 70% of patients with grade IIB and more than 90% of patients with grade III injury are likely to develop esophageal stricture. Stricture formation can be prevented by suppressing fibrosis and scar formation therefore; many agents are explored for treatment on various models in this subject.

Study Overview

• Status: Unknown
• Conditions: Clinico-epidemiological Characteristics of Corrosive Patients Presenting at Assiut Governorate
• Intervention / Treatment: Behavioral: development of complications or not

Detailed Description

In spite of the multiple efforts to educate the public, Caustic ingestion maintains its place as an important public health issue due to the availability of caustic agents and the loose regulatory control on its production. All the cases will be evaluated by detailed history and thorough physical examination and necessary investigations. Patient's sheet will include; name, age, sex, occupation, residence, type of administrated substance, route and mode of exposure, symptoms and sighs (pain , vomiting , diarrhea) and any received treatment.

• Study Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cases diagnosed as acute corrosive toxicity which admitted to emergency unit Assiut University Hospital ,children university hospital and ministry of health hospitals in Assiut in duration of one year.

Description

Inclusion Criteria:

-1- All the cases with the primary diagnosis of acute caustic injury will be included in the study.

2- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

• 1- Caustic substance ingested patient with any chronic disease. 2- Patients with history of congenital esophageal stricture. 3- Unable to provide informed consent. 4- Unlikely to return at 8 weeks. 5- Ingestion of substances other than corrosive (co-ingestion).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
corrosive patients	Behavioral: development of complications or not; assessment of development of complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fate of cases	development of esophageal stricture or not	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: EsophagealCorrosiveAssiut

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No