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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03729440
Recruitment Status : Unknown
Verified November 2018 by MKMAbdelrahim, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Information provided by (Responsible Party):
MKMAbdelrahim, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Clinico-epidemiological Characteristics of Corrosive Patients Presenting at Assiut Governorate 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Evaluation of Esophageal Injuries in Corrosives in Assiut Governorate - Experimental Comparison Between Different Treatments
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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

Primary Outcome Measures :
  1. fate of cases [ Time Frame: 6 months ]
    development of esophageal stricture or not

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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).
Additional Information:

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Responsible Party: MKMAbdelrahim, assistant lecturer, Assiut University Identifier: NCT03729440    
Other Study ID Numbers: EsophagealCorrosiveAssiut
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No