Clinical trial NCT04598880: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colonic Diseases
Keywords: Colonoscopy
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 1104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: High quality of entire colon cleansing according to the HS
timeFrame: At the time of colonoscopy
Secondary outcomes:
measure: High quality of segmental colon cleansing according to the HS
timeFrame: At the time of colonoscopy
measure: Successful global and segmental colon cleansing according to the HS
timeFrame: At the time of colonoscopy
measure: High quality and adequate quality of global and segmental colon cleansing according to the BBPS
timeFrame: At the time of colonoscopy
measure: Demographic variables
timeFrame: At the screening visit
measure: Variables associated with inadequate colon cleansing
timeFrame: At the screening visit
measure: Variables associated with neoplastic lesions
timeFrame: At the screening visit
measure: Adherence to colonoscopy preparation instructions
timeFrame: Before the colonoscopy
measure: Tolerance and acceptability of the colonoscopy preparation
timeFrame: Before the colonoscopy
measure: Variables on the lesions detected in the colonoscopy
timeFrame: At the time of colonoscopy
measure: Safety variables
timeFrame: Before the colonoscopy
Other outcomes:
Locations:
city: Viladecans
country: Spain
facility: Hospital de Viladecans
state: Barcelona
city: Alava
country: Spain
facility: Organización Sanitaria Integrada Araba
city: Almería
country: Spain
facility: Hospital de Poniente
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Marbella
country: Spain
facility: Hospital Costa del Sol
city: Málaga
country: Spain
facility: Hospital Quirón
city: Soria
country: Spain
facility: Hospital Santa Bárbara
Study officials:
affiliation: Hospital del Mar (Barcelona, Spain)
name: Marco Antonio Alvarez González, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario de Navarra (Pamplona, Spain)
name: Eduardo Albéniz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: