Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
1 other identifier
interventional
1,104
1 country
14
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®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2020
Shorter than P25 for phase_4
14 active sites
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
First Submitted
Initial submission to the registry
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
November 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedDecember 17, 2020
October 1, 2020
6 months
October 16, 2020
December 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
High quality of entire colon cleansing according to the HS
High quality cleansing in the entire colon (global) according to the HS, which is defined as all segments with a score of 3 or 4 points.
At the time of colonoscopy
Secondary Outcomes (10)
High quality of segmental colon cleansing according to the HS
At the time of colonoscopy
Successful global and segmental colon cleansing according to the HS
At the time of colonoscopy
High quality and adequate quality of global and segmental colon cleansing according to the BBPS
At the time of colonoscopy
Demographic variables
At the screening visit
Variables associated with inadequate colon cleansing
At the screening visit
- +5 more secondary outcomes
Study Arms (2)
Pleinvue
EXPERIMENTALSubjects receive polyethylene glycol + ascorbate (PEG1A) as laxative treatment for colonoscopy preparation.
Citrafleet
EXPERIMENTALSubjects receive sodium picosulfate + magnesium citrate (PSCM) as laxative treatment for colonoscopy preparation.
Interventions
Pleinvue® is administered orally in 2 doses (3 sachets) as per SmPC within the previous 18 hours to colonoscopy intervention. First dose is administered at 9 pm on the day before intervention (sachet 1: MACROGOL 3350 100 g + SODIUM SULFATE ANHYDROUS 9 g + SODIUM CHLORIDE 2 g + POTASSIUM CHLORIDE 1 g). Second dose is administered 5 hours before intervention and it is composed by 2 sachets (sachet A: MACROGOL 3350 40 g + SODIUM CHLORIDE 3,2 g + POTASSIUM CHLORIDE 1,2 g; sachet B: SODIUM ASCORBATE 48,11 g + ASCORBIC ACID 7,54 g).
Citrafleet® is administered orally in 2 doses (2 sachets) as per SmPC within the previous 18 hours to colonoscopy intervention. First dose (sachet 1) is administered at 9 pm on the day before intervention. Second dose (sachet 2) is administered 5 hours before intervention. Sachets 1 and 2 have the same composition: SODIUM PICOSULFATE 10 mg + MAGNESIUM OXIDE 3,5 g + CITRIC ACID 10,97 g.
Eligibility Criteria
You may qualify if:
- Outpatients with previously scheduled colonoscopy with any indication: screening, follow-up, or symptoms.
You may not qualify if:
- Age less than 18 years or more than 85 years
- Hospital admission at the time of colonoscopy
- Partial or total colectomy
- Severe constipation
- Active inflammatory bowel disease
- Severe kidney or liver failure
- Pregnancy or lactation
- Inability to understand the instructions by language barrier or cognitive disorder
- Refusal to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Hospital de Viladecans
Viladecans, Barcelona, Spain
Organización Sanitaria Integrada Araba
Alava, Spain
Hospital de Poniente
Almería, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Virgen de las Nieves
Granada, Spain
Clínica Universidad de Navarra
Madrid, Spain
Hospital de la Princesa
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Costa del Sol
Marbella, Spain
Hospital Quirón
Málaga, Spain
Hospital Santa Bárbara
Soria, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Antonio Alvarez González, MD, PhD
Hospital del Mar (Barcelona, Spain)
- PRINCIPAL INVESTIGATOR
Eduardo Albéniz, MD, PhD
Complejo Hospitalario de Navarra (Pamplona, Spain)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assignment of each treatment will be displayed at the time of patient enrollment and will be open to the participant and the physician. The investigator who performs the colonoscopy and assesses the primary outcome (digestive endoscopist) is blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 22, 2020
Study Start
November 6, 2020
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
December 17, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share