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

Colonic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598880
• Other study ID #: 2020/9317
• Status: Recruiting
• Phase: Phase 4
• Start date: November 6, 2020
• Est. completion date: May 2021

Study information

• Verified date: October 2020
• Source: Parc de Salut Mar
• Contact: Marco Antonio Alvarez González, MD, PhD
• Phone: +34932483057
• Email: MAAlvarez[@]parcdesalutmar.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1104
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Diseases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
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 Quirón	Málaga
Spain	Hospital Costa del Sol	Marbella
Spain	Hospital Santa Bárbara	Soria
Spain	Hospital de Viladecans	Viladecans	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At the time of colonoscopy
Secondary	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.	At the time of colonoscopy
Secondary	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.	At the time of colonoscopy
Secondary	Demographic variables	Collected through an anamnesis in a structured interview at the beginning of the study.	At the screening visit
Secondary	Variables associated with inadequate colon cleansing	Collected through an anamnesis in a structured interview at the beginning of the study.	At the screening visit
Secondary	Variables associated with neoplastic lesions	Collected through an anamnesis in a structured interview at the beginning of the study.	At the screening visit
Secondary	Adherence to colonoscopy preparation instructions	Collected according to a validated questionnaire before the colonoscopy.	Before the colonoscopy
Secondary	Tolerance and acceptability of the colonoscopy preparation	Collected according to a validated questionnaire before the colonoscopy.	Before the colonoscopy
Secondary	Variables on the lesions detected in the colonoscopy	Collected through the colonoscopy report and the anatomopathological analysis of the lesions.	At the time of colonoscopy
Secondary	Safety variables	The adverse effects of the laxatives administered will be collected before the colonoscopy.	Before the colonoscopy