Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04598880
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-10-16
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:
UNKNOWN
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:
Background
Colorectal cancer is the most frequent neoplasm and the second cause of cancer death in Spain Colon cleansing is critical for visualization of lesions at colonoscopy High-quality cleansing allows for correct detection and resection of all lesions and may contribute to adequate risk stratification and follow-up interval
Low-volume laxatives improve tolerance of the colonoscopy preparation without reducing its effectiveness Currently the most widely used low-volume laxatives are one liter of Polyethylene glycol ascorbate PEG1A and sodium picosulfate magnesium citrate PSCM
The evidence on the comparison of laxatives to achieve a high-quality colonic cleansing is very scarce
Hypothesis
Polyethylene glycol 1 liter with ascorbate is superior to sodium picosulfate and magnesium citrate in high-quality colon cleansing
Objective
Overall objective
To compare the global high-quality cleansing frequency between the two laxatives using the Harefield Scale HS
The primary objective is to demonstrate non-inferiority in global high-quality cleansing of PEG1A compared to PSCM If non-inferiority is demonstrated superiority of PEG1A will be analyzed
Specific objectives
Frequency of global high-quality cleansing using the Boston Bowel Preparation Scale BBPS
Frequency of adequate-quality cleansing using the HS and BBPS scales
Tolerance and adverse effects of both laxatives
Detection of lesions total adenomas advanced adenomas total serrated lesions advanced serrated lesions and colorectal cancer
Detection of neoplastic lesions in the different colon segments proximal transverse descending sigmoid and rectum
Association between detected lesions and the quality of the preparation according to the HS and BBPS scales
Methods
Phase 4 multi-centric randomized single-blind endoscopist parallel study with two treatment arms PEG1A Pleinvue and PSCM Citrafleet
Colorectal cancer is the most frequent neoplasm and the second cause of cancer death in Spain Colon cleansing is critical for visualization of lesions at colonoscopy High-quality cleansing allows for correct detection and resection of all lesions and may contribute to adequate risk stratification and follow-up interval
Low-volume laxatives improve tolerance of the colonoscopy preparation without reducing its effectiveness Currently the most widely used low-volume laxatives are one liter of Polyethylene glycol ascorbate PEG1A and sodium picosulfate magnesium citrate PSCM
The evidence on the comparison of laxatives to achieve a high-quality colonic cleansing is very scarce
Hypothesis
Polyethylene glycol 1 liter with ascorbate is superior to sodium picosulfate and magnesium citrate in high-quality colon cleansing
Objective
Overall objective
To compare the global high-quality cleansing frequency between the two laxatives using the Harefield Scale HS
The primary objective is to demonstrate non-inferiority in global high-quality cleansing of PEG1A compared to PSCM If non-inferiority is demonstrated superiority of PEG1A will be analyzed
Specific objectives
Frequency of global high-quality cleansing using the Boston Bowel Preparation Scale BBPS
Frequency of adequate-quality cleansing using the HS and BBPS scales
Tolerance and adverse effects of both laxatives
Detection of lesions total adenomas advanced adenomas total serrated lesions advanced serrated lesions and colorectal cancer
Detection of neoplastic lesions in the different colon segments proximal transverse descending sigmoid and rectum
Association between detected lesions and the quality of the preparation according to the HS and BBPS scales
Methods
Phase 4 multi-centric randomized single-blind endoscopist parallel study with two treatment arms PEG1A Pleinvue and PSCM Citrafleet
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