Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2025-12-16 @ 11:11 PM
Study NCT ID:
NCT04598880
Status:
None
Last Update Posted:
2020-12-17 00:00:00
First Post:
2020-10-16 00:00:00
Brief Title:
Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
Status:
None
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be performed in 1104 patients with a scheduled colonoscopy for any indication, who need a bowel preparation for the colonoscopy.
Subjects will be randomly assigned to 1 of 2 treatment groups with a 1:1 allocation using block sizes of 6 cases in each center. The treatment assignment will be open to the participant and the physician. The investigator who performs the colonoscopy and assesses the primary outcome (digestive endoscopist) will be blinded.
In both treatment groups, participants will receive instructions about colonoscopy preparation. Laxative treatment (PEG1A/PSCM) will be administered in two doses, at 9 pm on the day before intervention and 5 hours before colonoscopy, on an outpatient basis.
The day of the colonoscopy appointment will be the final visit of the study. The participant will be asked through a questionnaire about adherence to instructions, tolerance and acceptability to the preparation, and the appearance of side effects. No follow-up period is considered after intervention.
Subjects will be randomly assigned to 1 of 2 treatment groups with a 1:1 allocation using block sizes of 6 cases in each center. The treatment assignment will be open to the participant and the physician. The investigator who performs the colonoscopy and assesses the primary outcome (digestive endoscopist) will be blinded.
In both treatment groups, participants will receive instructions about colonoscopy preparation. Laxative treatment (PEG1A/PSCM) will be administered in two doses, at 9 pm on the day before intervention and 5 hours before colonoscopy, on an outpatient basis.
The day of the colonoscopy appointment will be the final visit of the study. The participant will be asked through a questionnaire about adherence to instructions, tolerance and acceptability to the preparation, and the appearance of side effects. No follow-up period is considered after intervention.
Detailed Description:
This study will be performed in 1104 patients with a scheduled colonoscopy for any indication who need a bowel preparation for the colonoscopy
Subjects will be randomly assigned to 1 of 2 treatment groups with a 11 allocation using block sizes of 6 cases in each center The treatment assignment will be open to the participant and the physician The investigator who performs the colonoscopy and assesses the primary outcome digestive endoscopist will be blinded
In both treatment groups participants will receive instructions about colonoscopy preparation Laxative treatment PEG1APSCM will be administered in two doses at 9 pm on the day before intervention and 5 hours before colonoscopy on an outpatient basis
The day of the colonoscopy appointment will be the final visit of the study The participant will be asked through a questionnaire about adherence to instructions tolerance and acceptability to the preparation and the appearance of side effects No follow-up period is considered after intervention
Subjects will be randomly assigned to 1 of 2 treatment groups with a 11 allocation using block sizes of 6 cases in each center The treatment assignment will be open to the participant and the physician The investigator who performs the colonoscopy and assesses the primary outcome digestive endoscopist will be blinded
In both treatment groups participants will receive instructions about colonoscopy preparation Laxative treatment PEG1APSCM will be administered in two doses at 9 pm on the day before intervention and 5 hours before colonoscopy on an outpatient basis
The day of the colonoscopy appointment will be the final visit of the study The participant will be asked through a questionnaire about adherence to instructions tolerance and acceptability to the preparation and the appearance of side effects No follow-up period is considered after intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None