Comparing lactulose and polyethylene glycol for bowel preparation before colonoscopy
Bowel Preparation in Colonoscopy: Lactulose Vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.
PHASE4 · Hospital Civil de Guadalajara · NCT06666556
This study is testing whether lactulose or polyethylene glycol works better for cleaning out the bowels before a colonoscopy to see which one makes the process easier and more satisfying for patients.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Hospital Civil de Guadalajara (other) |
| Locations | 3 sites (Guadalajara, Jalisco and 2 other locations) |
| Trial ID | NCT06666556 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and patient satisfaction of lactulose versus polyethylene glycol as bowel preparation agents for colonoscopy. It involves a randomized, double-blind methodology across multiple centers, focusing on how well each agent cleanses the bowel to enhance the quality of the colonoscopy procedure. The study will assess factors such as the efficiency of bowel cleansing, patient tolerance, and overall satisfaction with the preparation process. By determining which agent provides better outcomes, the trial seeks to improve the colonoscopy experience for patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-79 who are scheduled for a colonoscopy and can provide informed consent.
Not a fit: Patients under 18 or over 80 years old, those with a history of colorectal cancer, or individuals with severe medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved bowel preparation methods, enhancing the quality of colonoscopy and patient satisfaction.
How similar studies have performed: Previous studies have shown varying success with different bowel preparation agents, but this specific comparison of lactulose and polyethylene glycol is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion Criteria: * Patients with indication for colonoscopy in our coloproctology service * Both women and men * Patients within an age range of 18-79 years * Patients who agree having a colonoscopy and who sign the informed consent to participate in the protocol Exclusion Criteria: * Patients under 18 or over 80 years old * All patients that won´t like to participate in the protocol or won´t sign the informed consent * Pregnant women * Patients with a medical record of colonic resection, ostomy status, severe cardiopulmonary and renal diseases, major psychiatric disorders, therapeutic colonoscopy or any contraindications for colonoscopy * Non compliance with the colonic preparation regimen * Active bleeding during the procedure * Patients with a known diagnosis of colorectal cancer
Where this trial is running
Guadalajara, Jalisco and 2 other locations
- Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde" — Guadalajara, Jalisco, Mexico (RECRUITING)
- Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca" — Guadalajara, Jalisco, Mexico (RECRUITING)
- IMSS Hospital General Regional 220 "José Vicente Villada" — México, Toluca de Lerdo, Mexico (RECRUITING)
Study contacts
- Study coordinator: Roberto U M. C. Roberto Ulises Cruz Neri (Master in Science, Medical Sta, M. C
- Email: robertocruzneri@gmail.com
- Phone: +52 3311946664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer Screening, colorectal, colorectal cancer, colorectal cancer screening, colonoscopy, polyethylenglycol, lactulose