Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
NCT ID: NCT04598880
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1104 participants
INTERVENTIONAL
2020-11-06
2021-05-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pleinvue
Subjects receive polyethylene glycol + ascorbate (PEG1A) as laxative treatment for colonoscopy preparation.
Polyethylene glycol + ascorbate
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
Subjects receive sodium picosulfate + magnesium citrate (PSCM) as laxative treatment for colonoscopy preparation.
Sodium picosulfate + magnesium citrate
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.
Interventions
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Polyethylene glycol + ascorbate
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).
Sodium picosulfate + magnesium citrate
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Parc de Salut Mar
OTHER
Responsible Party
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Principal Investigators
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Marco Antonio Alvarez González, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar (Barcelona, Spain)
Eduardo Albéniz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitalario de Navarra (Pamplona, Spain)
Locations
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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, , 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
Countries
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Central Contacts
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Facility Contacts
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Ana García Rodríguez
Role: primary
Aitor Oribe
Role: primary
Francisco Gallego Rojo
Role: primary
Ingrid Marín Fernández
Role: primary
Marco Antonio Alvarez González, MD, PhD
Role: primary
Eduardo Redondo Cerezo
Role: primary
Jose María Riesco
Role: primary
Pablo Miranda
Role: primary
Oscar Nogales Rincón
Role: primary
Pedro de María Pallarés
Role: primary
Enrique Rodríguez de Santiago
Role: primary
Andrés Sánchez Yague
Role: primary
Pedro Rosón
Role: primary
Santiago Frago Larramona
Role: primary
Other Identifiers
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2020/9317
Identifier Type: -
Identifier Source: org_study_id