Usefulness of strengthering the bowel-cleansing preparation in patients with weak previous colonoscopy preparation

Usefulness of strengthering the bowel-cleansing preparation with Macrogol 3350 in patients with weak previous colonoscopy preparation - MacroCOL

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001277-93-ES

Enrollment

Registered

2019-07-26

Start date

2019-09-27

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer MedDRA version: 21.0 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations MedDRA version: 21.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Movicol Product Name: Movicol Product Code: 71116 Pharmaceutical Form: Granules and solvent for oral suspension INN or Propo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subjects that have been previously included in the polyps follow-up program (screening) of the high-risk colorectal cancer. - Subjects over 18 and under 80 years of age. - Subjects who, after performing a correct previous preparation, present insufficient cleaning on the colonoscopy (score on the Boston scale of less than 2 in each segment of the colon). - Subjects that agree to participate and sign the informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22

Exclusion criteria

Exclusion criteria: - Patients with intestinal resections - Patients with Inflammatory Bowel Disease - Hospitalized patients - Patients with intolerance or allergy to Macrogol 3350 - Patients who prefer another type of preparation that is not a Bohm® evacuating solution

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the different quality results of colonoscopy between the strengthening preparation with Macrogol 3350 and the results of previous colonoscopy without Macrogol 3350.;Secondary Objective: Assess the different number of polyps detected between the strengthening preparation with Macrogol 3350 and the results of previous colonoscopy without Macrogol 3350.;Primary end point(s): Quality of the colonoscopy measured according to the Boston scale by sections.;Timepoint(s) of evaluation of this end point: During the colonoscopy	—

Measure

Time frame

Main Objective: Assess the different quality results of colonoscopy between the strengthening preparation with Macrogol 3350 and the results of previous colonoscopy without Macrogol 3350.;Secondary Objective: Assess the different number of polyps detected between the strengthening preparation with Macrogol 3350 and the results of previous colonoscopy without Macrogol 3350.;Primary end point(s): Quality of the colonoscopy measured according to the Boston scale by sections.;Timepoint(s) of evaluation of this end point: During the colonoscopy

—

Secondary

Measure	Time frame
Secondary end point(s): Enhances detection of polyps;Timepoint(s) of evaluation of this end point: During the colonoscopy	—

Countries

Spain

Contacts

Public ContactClinical Trial Information

Príncipe de Asturias University Hospital

andressro@hotmail.com349188781002610

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026