Mucolytic Solution Before Upper Endoscopy
The Use of Mucolytic Solution Before Upper Endoscopy: A Randomized, Double-blinded Trial
1 other identifier
interventional
150
1 country
1
Brief Summary
Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of gastric mucosa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 10, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedNovember 29, 2016
November 1, 2016
4 months
November 10, 2016
November 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
"Visibility score" evaluated by blinded performing endoscopist
"Visibility score" (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).
through study completion, an average of 3 months
Secondary Outcomes (3)
"Visibility score" evaluated by three blinded endoscopists using 11 endoscopic images captured during endoscopy.
through study completion, an average of 3 months
Residual fluid in the stomach evaluated by blinded performing endoscopist
through study completion, an average of 3 months
Duration of endoscopy
through study completion, an average of 3 months
Study Arms (3)
A - mucolytic solution
EXPERIMENTALMucolytic solution consisting of 100 ml of water, 100 mg of simethicon and 400 mg of N-acetylcystein administered 30 minutes prior to upper endoscopy.
B - no intervention
NO INTERVENTIONUpper endoscopy without neither mucolytic solution nor water prior to upper endoscopy.
C - water
PLACEBO COMPARATOR100 ml of water given 30 minutes prior to upper endoscopy.
Interventions
Eligibility Criteria
You may qualify if:
- age \> 18 years
- signed informed consent
- diagnostic gastroscopy
You may not qualify if:
- age \< 18 years
- interventional gastroscopy
- known disease of the upper GI tract and/or history of surgery of GI tract
- gastroscopy indicated of bleeding, dysphagia or ileus
- liver cirrhosis
- general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Digestive Diseases Center
Ostrava, 70384, Czechia
Related Publications (1)
Stepan M, Falt P, Pipek B, Fojtik P, Hanousek M, Hill M, Urban O. Administration of mucolytic solution before upper endoscopy - double-blind, monocentric, randomized study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2023 Mar;167(1):69-73. doi: 10.5507/bp.2021.038. Epub 2021 Jun 22.
PMID: 34158672DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Premysl Falt, M.D., Ph.D.
Digestive Diseases Center, Vítkovice Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 10, 2016
First Posted
November 17, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2017
Study Completion
May 1, 2017
Last Updated
November 29, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share