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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
MKMAbdelrahim, Assiut University

Tracking Information
First Submitted Date November 1, 2018
First Posted Date November 2, 2018
Last Update Posted Date November 2, 2018
Estimated Study Start Date January 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2018)
fate of cases [ Time Frame: 6 months ]
development of esophageal stricture or not
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Esophageal Injuries in Corrosives in Assiut Governorate - Experimental Comparison Between Different Treatments
Official Title Evaluation of Esophageal Injuries in Corrosives in Assiut Governorate - Experimental Comparison Between Different Treatments
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.
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 [Patient Registry]
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration 28 Days
Biospecimen Not Provided
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.
Condition Clinico-epidemiological Characteristics of Corrosive Patients Presenting at Assiut Governorate
Intervention Behavioral: development of complications or not
assessment of development of complications
Study Groups/Cohorts corrosive patients
Intervention: Behavioral: development of complications or not
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 1, 2018)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03729440
Other Study ID Numbers EsophagealCorrosiveAssiut
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party MKMAbdelrahim, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date November 2018