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A randomized, controlled study on the use of antifoaming and mucolytic agents in preparation for upper digestive endoscopy

Use of mucolytics and antifoams in preparation for Upper Digestive Endoscopy diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2n9x58k
Enrollment
Unknown
Registered
2024-12-19
Start date
2020-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

Interventions

This is a longitudinal, randomized, controlled, double-blind study, with a sample of 300 patients undergoing routine upper digestive endoscopy, randomized 1 by 1, through a draw into two arms to recei
E01.390.500

Sponsors

Instituto Hospital de Base do Distrito Federal
Lead Sponsor
Instituto de Gestão Estratégica de Saúde do Distrito Federal
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Outpatient care for diagnostic upper gastrointestinal endoscopy; age greater than or equal to 18 years; both sexes

Exclusion criteria

Exclusion criteria: Patients who did not sign the Informed Consent Form; those who had forms filled out incompletely; patients with malignant gastrointestinal tract diseases; and neurological diseases; with an indication of therapeutic procedures at the time of the examination; the presence of food residues in the esophagus or stomach

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Better efficacy of the solution containing mucolytic agents with antifoams in clearing mucus and bubbles from the gastric mucosa during diagnostic upper digestive endoscopy ;Finding outcome 1: Mucolytic agents with antifoam did not show superiority over a group with antifoam alone. More studies are needed to prove the real benefit of this combination

Secondary

MeasureTime frame
Expected outcome 2: Compare the mucosal visibility index, the volume of liquids needed to achieve adequate mucosal vision, and the total procedure time between the two solutions ;Finding Outcome 2: Compared to placebo, the simethicone plus NAC solution significantly improved visibility in the antrum. Further studies are needed to evaluate the optimal doses, volumes, and administration times of pre-endoscopic solutions and determine the impact of using these solutions on the lesion detection rate

Countries

Brazil

Contacts

Public ContactDaniela Louro

Instituto Hospital de Base

daniela.mac@gmail.com+55(61)996061910

Outcome results

None listed

Source: REBEC (via WHO ICTRP)