Clinical trial on the assessment of mucosal visualization quality and diagnostic performance in small bowel capsule endoscopy using different preparation protocols

Conditions

Comparison of diagnostic tools

Brief summary

Degree of small bowel cleansing using an accepted cleansing scale.

Detailed description

Diagnostic yield of capsule endoscopy defined as: finding of clinically significant lesions., Gastric transit time (GTT): Defined as the time elapsed from the first gastric image to the first duodenal image. This value will be expressed in minutes., Small bowel transit time (STT): This is defined as the time elapsed from the first duodenal image to the first cecal image. When the study does not reach the cecum, the last image of the study will be considered as the first cecal image and it will be indicated that the cecum has not been reached. This value will be expressed in minutes., Tolerability of the preparation: Expresses the degree of acceptance or non-acceptance by the patient of the preparation. For this purpose, a questionnaire will be used, which is not validated, and will be completed at the time the capsule is administered., Percentage of complete studies: A study is considered complete when it has reached the blind spot during the recording time., Other variables: Demographic variables: age, gender, personal history. Reason for requesting capsule endoscopy and diagnosis found. Previous treatment with antiplatelet agents, anticoagulants, non-steroidal anti-inflammatory drugs and/or prokinetics.

Related papers

No related papers found yet.

Interventions

DRUGMOVIPREP

DRUGAero-red 100 mg/ml gotas orales en solución

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Degree of small bowel cleansing using an accepted cleansing scale.	—

Secondary

Measure	Time frame
Diagnostic yield of capsule endoscopy defined as: finding of clinically significant lesions., Gastric transit time (GTT): Defined as the time elapsed from the first gastric image to the first duodenal image. This value will be expressed in minutes., Small bowel transit time (STT): This is defined as the time elapsed from the first duodenal image to the first cecal image. When the study does not reach the cecum, the last image of the study will be considered as the first cecal image and it will be indicated that the cecum has not been reached. This value will be expressed in minutes., Tolerability of the preparation: Expresses the degree of acceptance or non-acceptance by the patient of the preparation. For this purpose, a questionnaire will be used, which is not validated, and will be completed at the time the capsule is administered., Percentage of complete studies: A study is considered complete when it has reached the blind spot during the recording time., Other variables: Demograp	—

Measure

Time frame

Diagnostic yield of capsule endoscopy defined as: finding of clinically significant lesions., Gastric transit time (GTT): Defined as the time elapsed from the first gastric image to the first duodenal image. This value will be expressed in minutes., Small bowel transit time (STT): This is defined as the time elapsed from the first duodenal image to the first cecal image. When the study does not reach the cecum, the last image of the study will be considered as the first cecal image and it will be indicated that the cecum has not been reached. This value will be expressed in minutes., Tolerability of the preparation: Expresses the degree of acceptance or non-acceptance by the patient of the preparation. For this purpose, a questionnaire will be used, which is not validated, and will be completed at the time the capsule is administered., Percentage of complete studies: A study is considered complete when it has reached the blind spot during the recording time., Other variables: Demograp

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Countries

Spain

Outcome results

None listed