RecruitingPhase 4NCT05436054

A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy

A Randomised Controlled Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy


Sponsor

Aalborg University Hospital

Enrollment

400 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to visual examination of the large bowel to exclude cancer disease. 400 patients who are referred for colonoscopy to a single center in North Jutland will be randomised either to Picoprep or Plenvu. These patients will then answer a questionnaire prior to colonoscopy. The questionnaire is about the most common expected side effects and the experience of cleansing og intake of the bowel agents. The effect of the two agents will examined using a special scoring system (Harefield) to determine the quality of bowel cleansing. Colonoscopist who evaluate the cleansing is blinded to which agent the patient has taken.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Ambulant colonoscopy
  • Older than18

Exclusion Criteria12

  • Younger than 18
  • Known with severe heart failure
  • Known with severe renal failure (eGFR<30)
  • Known for colonic stenosis
  • Pregnant or breastfeeding
  • Acute colonoscopy
  • Cancer screening program colonoscopy
  • Mentally retarded
  • Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation.
  • Patients with Phenylketonuria
  • Patients with Glucose-6-phosphate-dehydrogenase deficiency
  • Patients with colon or rectum resection

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Interventions

DRUGPicoprep

200 patients will be randomised to this arm

DRUGPlenvu

200 patients will be randomised to this arm


Locations(1)

Aalborg University hospital

Aalborg, North Jutland, Denmark

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NCT05436054


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