Multidisciplinary approach versus conventional approach in colonic preparation of hospitalized patients. A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000869-36-ES

Enrollment

162

Registered

2013-04-09

Start date

2013-06-28

Completion date

Unknown

Last updated

2023-10-23

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

Conditions

Colon preparation for colonoscopy MedDRA version: 14.1 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations

Interventions

Trade Name: solución evacuante Bohm sobres Product Name: Polietilenglicol Pharmaceutical Form: Powder for oral solution in sachet INN or Proposed INN: Macrogol CAS Number: 25322-68-3 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hospitalized patients who undergo a non urgent colonoscopy 2. Patients who give informed consent to participate in the study 3. Patients older than 18 years 4. Patients who undergo total colonoscolpy 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 81 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 81

Exclusion criteria

Exclusion criteria: 1. Non compliance with the 48 hours diet prescribed 2. The endoscopy planned is a rectosigmoidoscopy 3. Previous colonic surgery 4. Mental/cognitive impairment preventing tthe study assessments 5. Severe renal failure 6. Electrolitic disbalance (hyponatremia, hypokaliemia, Hyperfosfatemia, hypocalcemia and hypomagnesemia) 7. Intestinal obstruction, perforation or toxic megacolon 8. Pregnant or nursing women 9. Alergy/intolerance to PEG, bisacodyl or adjuvants 10. No informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of a multidisciplinary approach (education, low fiber diet, PEG 2L bisacodyl and adjuvant) versus a conventional approach (low fiber diet plus PEG 4 L) in cleaning the colon of hospitalized patients;Secondary Objective: Not applicable;Primary end point(s): percentage of patients with adequate bowel preparation, defined as a preparation which allows exploring the whole colonic mucose and detecting flat lesions (Rating as good or excellent in the Boston Bowel preparation scale);Timepoint(s) of evaluation of this end point: The evaluation of this endpoint will be during the colonoscopy	—

Measure

Time frame

Main Objective: To compare the efficacy of a multidisciplinary approach (education, low fiber diet, PEG 2L bisacodyl and adjuvant) versus a conventional approach (low fiber diet plus PEG 4 L) in cleaning the colon of hospitalized patients;Secondary Objective: Not applicable;Primary end point(s): percentage of patients with adequate bowel preparation, defined as a preparation which allows exploring the whole colonic mucose and detecting flat lesions (Rating as good or excellent in the Boston Bowel preparation scale);Timepoint(s) of evaluation of this end point: The evaluation of this endpoint will be during the colonoscopy

—

Secondary

Measure	Time frame
Secondary end point(s): Percentage of patients with adequate bowel preparation by bowel segments, tolerance to the colonoscopy, colonoscopy findings, percentage of complete/uncomplete colonoscopies and reprogramming, complications during and after the procedure, doses of sedation needed during the colonoscopy;Timepoint(s) of evaluation of this end point: The evaluation of this endpoint will be during and after the colonoscopy	—

Measure

Time frame

Secondary end point(s): Percentage of patients with adequate bowel preparation by bowel segments, tolerance to the colonoscopy, colonoscopy findings, percentage of complete/uncomplete colonoscopies and reprogramming, complications during and after the procedure, doses of sedation needed during the colonoscopy;Timepoint(s) of evaluation of this end point: The evaluation of this endpoint will be during and after the colonoscopy

—

Countries

Spain

Contacts

Public ContactConsultant Physician - Gastroentero

Fundació Parc Taulí

fjunquera@tauli.cat34937458451

Outcome results

None listed

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