Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing

Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing

Sponsors

Lead Sponsor: Parc de Salut Mar

Source Parc de Salut Mar
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.

Overall Status Recruiting
Start Date 2020-11-06
Completion Date 2021-05-01
Primary Completion Date 2021-05-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
High quality of entire colon cleansing according to the HS At the time of colonoscopy
Secondary Outcome
Measure Time Frame
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
Variables associated with neoplastic lesions At the screening visit
Adherence to colonoscopy preparation instructions Before the colonoscopy
Tolerance and acceptability of the colonoscopy preparation Before the colonoscopy
Variables on the lesions detected in the colonoscopy At the time of colonoscopy
Safety variables Before the colonoscopy
Enrollment 1104
Condition
Intervention

Intervention Type: Drug

Intervention Name: Polyethylene glycol + ascorbate

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).

Arm Group Label: Pleinvue

Intervention Type: Drug

Intervention Name: Sodium picosulfate + magnesium citrate

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.

Arm Group Label: Citrafleet

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

85 Years

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Marco Antonio Alvarez González, MD, PhD

Phone: +34932483057

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Hospital de Viladecans | Viladecans, Barcelona, Spain Not yet recruiting Ana García Rodríguez +34936590111 [email protected] Ana García Rodríguez Sub-Investigator
Organización Sanitaria Integrada Araba | Alava, Spain Not yet recruiting Aitor Oribe +34945007000 [email protected] Aitor Oribe Sub-Investigator
Hospital de Poniente | Almería, Spain Not yet recruiting Francisco Gallego Rojo +34950022942 [email protected] Francisco Gallego Rojo Sub-Investigator
Hospital Germans Trias i Pujol | Badalona, Spain Not yet recruiting Ingrid Marín Fernández +34934978800 [email protected] Ingrid Marín Fernández Sub-Investigator
Hospital del Mar | Barcelona, 08003, Spain Recruiting Marco Antonio Alvarez González, MD, PhD +34932483057 [email protected] Marco Antonio Alvarez González, MD, PhD Principal Investigator
Hospital Virgen de las Nieves | Granada, Spain Not yet recruiting Eduardo Redondo Cerezo +34958020146 [email protected] Eduardo Redondo Cerezo Sub-Investigator
Clínica Universidad de Navarra | Madrid, Spain Not yet recruiting Jose María Riesco +34913531920 [email protected] Jose María Riesco Sub-Investigator
Hospital de la Princesa | Madrid, Spain Not yet recruiting Pablo Miranda +34915202250 [email protected] Pablo Miranda Sub-Investigator
Hospital Gregorio Marañón | Madrid, Spain Not yet recruiting Oscar Nogales Rincón +34915868307 [email protected] Oscar Nogales Rincón Sub-Investigator
Hospital La Paz | Madrid, Spain Not yet recruiting Pedro de María Pallarés +34917277000 [email protected] Pedro de María Pallarés Sub-Investigator
Hospital Ramón y Cajal | Madrid, Spain Not yet recruiting Enrique Rodríguez de Santiago +34913368772 [email protected] Enrique Rodríguez de Santiago Sub-Investigator
Hospital Costa del Sol | Marbella, Spain Not yet recruiting Andrés Sánchez Yague +34951976669 [email protected] Andrés Sánchez Yague Sub-Investigator
Hospital Quirón | Málaga, Spain Not yet recruiting Pedro Rosón +34951940000 [email protected] Pedro Rosón Sub-Investigator
Hospital Santa Bárbara | Soria, Spain Not yet recruiting Santiago Frago Larramona +34975234300 [email protected] Santiago Frago Larramona Sub-Investigator
Location Countries

Spain

Verification Date

2020-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Pleinvue

Type: Experimental

Description: Subjects receive polyethylene glycol + ascorbate (PEG1A) as laxative treatment for colonoscopy preparation.

Label: Citrafleet

Type: Experimental

Description: Subjects receive sodium picosulfate + magnesium citrate (PSCM) as laxative treatment for colonoscopy preparation.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention 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.

Primary Purpose: Treatment

Masking: Single (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.

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