Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
Primary Purpose
Colonic Diseases
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Polyethylene glycol + ascorbate
Sodium picosulfate + magnesium citrate
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Diseases focused on measuring Colonoscopy
Eligibility Criteria
Inclusion Criteria:
- Outpatients with previously scheduled colonoscopy with any indication: screening, follow-up, or symptoms.
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital de Viladecans
- Organización Sanitaria Integrada Araba
- Hospital de Poniente
- Hospital Germans Trias i Pujol
- Hospital del MarRecruiting
- Hospital Virgen de las Nieves
- Clínica Universidad de Navarra
- Hospital de la Princesa
- Hospital Gregorio Marañón
- Hospital La Paz
- Hospital Ramón y Cajal
- Hospital Costa del Sol
- Hospital Quirón
- Hospital Santa Bárbara
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pleinvue
Citrafleet
Arm Description
Subjects receive polyethylene glycol + ascorbate (PEG1A) as laxative treatment for colonoscopy preparation.
Subjects receive sodium picosulfate + magnesium citrate (PSCM) as laxative treatment for colonoscopy preparation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
High quality of segmental colon cleansing according to the HS
High quality cleansing in each segment of colon (segmental) according to the HS, which is defined as a score of 3 or 4 points.
Successful global and segmental colon cleansing according to the HS
Successful cleansing at a global and segmental level according to the HS, which is defined as a segmental score >=2 points, and at a global level, as all segments with a score of >=2 points.
High quality and adequate quality of global and segmental colon cleansing according to the BBPS
High quality cleansing at a segmental level according to the BBPS, which is defined as a score of 3 points, and at a global level, defined as all segments with a score of 3 points.
Adequate cleansing at segmental level according to the BBPS, which is defined as a segment with a score >=2 points, and at global level, defined as all segments with a score of >=2 points.
Demographic variables
Collected through an anamnesis in a structured interview at the beginning of the study.
Variables associated with inadequate colon cleansing
Collected through an anamnesis in a structured interview at the beginning of the study.
Variables associated with neoplastic lesions
Collected through an anamnesis in a structured interview at the beginning of the study.
Adherence to colonoscopy preparation instructions
Collected according to a validated questionnaire before the colonoscopy.
Tolerance and acceptability of the colonoscopy preparation
Collected according to a validated questionnaire before the colonoscopy.
Variables on the lesions detected in the colonoscopy
Collected through the colonoscopy report and the anatomopathological analysis of the lesions.
Safety variables
The adverse effects of the laxatives administered will be collected before the colonoscopy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04598880
Brief Title
Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
Official Title
Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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®).
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases
Keywords
Colonoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
1104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pleinvue
Arm Type
Experimental
Arm Description
Subjects receive polyethylene glycol + ascorbate (PEG1A) as laxative treatment for colonoscopy preparation.
Arm Title
Citrafleet
Arm Type
Experimental
Arm Description
Subjects receive sodium picosulfate + magnesium citrate (PSCM) as laxative treatment for colonoscopy preparation.
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol + ascorbate
Other Intervention Name(s)
Pleinvue®, PEG1A
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Sodium picosulfate + magnesium citrate
Other Intervention Name(s)
Citrafleet®, PSCM
Intervention Description
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.
Primary Outcome Measure Information:
Title
High quality of entire colon cleansing according to the HS
Description
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.
Time Frame
At the time of colonoscopy
Secondary Outcome Measure Information:
Title
High quality of segmental colon cleansing according to the HS
Description
High quality cleansing in each segment of colon (segmental) according to the HS, which is defined as a score of 3 or 4 points.
Time Frame
At the time of colonoscopy
Title
Successful global and segmental colon cleansing according to the HS
Description
Successful cleansing at a global and segmental level according to the HS, which is defined as a segmental score >=2 points, and at a global level, as all segments with a score of >=2 points.
Time Frame
At the time of colonoscopy
Title
High quality and adequate quality of global and segmental colon cleansing according to the BBPS
Description
High quality cleansing at a segmental level according to the BBPS, which is defined as a score of 3 points, and at a global level, defined as all segments with a score of 3 points.
Adequate cleansing at segmental level according to the BBPS, which is defined as a segment with a score >=2 points, and at global level, defined as all segments with a score of >=2 points.
Time Frame
At the time of colonoscopy
Title
Demographic variables
Description
Collected through an anamnesis in a structured interview at the beginning of the study.
Time Frame
At the screening visit
Title
Variables associated with inadequate colon cleansing
Description
Collected through an anamnesis in a structured interview at the beginning of the study.
Time Frame
At the screening visit
Title
Variables associated with neoplastic lesions
Description
Collected through an anamnesis in a structured interview at the beginning of the study.
Time Frame
At the screening visit
Title
Adherence to colonoscopy preparation instructions
Description
Collected according to a validated questionnaire before the colonoscopy.
Time Frame
Before the colonoscopy
Title
Tolerance and acceptability of the colonoscopy preparation
Description
Collected according to a validated questionnaire before the colonoscopy.
Time Frame
Before the colonoscopy
Title
Variables on the lesions detected in the colonoscopy
Description
Collected through the colonoscopy report and the anatomopathological analysis of the lesions.
Time Frame
At the time of colonoscopy
Title
Safety variables
Description
The adverse effects of the laxatives administered will be collected before the colonoscopy.
Time Frame
Before the colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients with previously scheduled colonoscopy with any indication: screening, follow-up, or symptoms.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Antonio Alvarez González, MD, PhD
Phone
+34932483057
Email
MAAlvarez@parcdesalutmar.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Antonio Alvarez González, MD, PhD
Organizational Affiliation
Hospital del Mar (Barcelona, Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eduardo Albéniz, MD, PhD
Organizational Affiliation
Complejo Hospitalario de Navarra (Pamplona, Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Viladecans
City
Viladecans
State/Province
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana García Rodríguez
Phone
+34936590111
Email
anagrod4@gmail.com
First Name & Middle Initial & Last Name & Degree
Ana García Rodríguez
Facility Name
Organización Sanitaria Integrada Araba
City
Alava
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aitor Oribe
Phone
+34945007000
Email
aitor_orive@yahoo.com
First Name & Middle Initial & Last Name & Degree
Aitor Oribe
Facility Name
Hospital de Poniente
City
Almería
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Gallego Rojo
Phone
+34950022942
Email
fgallegorojo@gmail.com
First Name & Middle Initial & Last Name & Degree
Francisco Gallego Rojo
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Marín Fernández
Phone
+34934978800
Email
gridin_8@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ingrid Marín Fernández
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Antonio Alvarez González, MD, PhD
Phone
+34932483057
Email
MAAlvarez@parcdesalutmar.cat
First Name & Middle Initial & Last Name & Degree
Marco Antonio Alvarez González, MD, PhD
Facility Name
Hospital Virgen de las Nieves
City
Granada
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Redondo Cerezo
Phone
+34958020146
Email
eredondoc@yahoo.es
First Name & Middle Initial & Last Name & Degree
Eduardo Redondo Cerezo
Facility Name
Clínica Universidad de Navarra
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose María Riesco
Phone
+34913531920
Email
cucoriesco@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jose María Riesco
Facility Name
Hospital de la Princesa
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Miranda
Phone
+34915202250
Email
pmpablomiranda@gmail.com
First Name & Middle Initial & Last Name & Degree
Pablo Miranda
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Nogales Rincón
Phone
+34915868307
Email
oscarnogalesrincon@gmail.com
First Name & Middle Initial & Last Name & Degree
Oscar Nogales Rincón
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro de María Pallarés
Phone
+34917277000
Email
pedro.demaria@gmail.com
First Name & Middle Initial & Last Name & Degree
Pedro de María Pallarés
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Rodríguez de Santiago
Phone
+34913368772
Email
e_rodriguez_de_santiago@hotmail.com
First Name & Middle Initial & Last Name & Degree
Enrique Rodríguez de Santiago
Facility Name
Hospital Costa del Sol
City
Marbella
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés Sánchez Yague
Phone
+34951976669
Email
asyague@gmail.com
First Name & Middle Initial & Last Name & Degree
Andrés Sánchez Yague
Facility Name
Hospital Quirón
City
Málaga
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Rosón
Phone
+34951940000
Email
pjroson@gmail.com
First Name & Middle Initial & Last Name & Degree
Pedro Rosón
Facility Name
Hospital Santa Bárbara
City
Soria
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santiago Frago Larramona
Phone
+34975234300
Email
santifrago@gmail.com
First Name & Middle Initial & Last Name & Degree
Santiago Frago Larramona
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
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