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

Condition(s) studied

Investigational drug(s) / intervention(s)

Picoprep: 200 patients will be randomised to this arm

Plenvu: 200 patients will be randomised to this arm

Study 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

Primary outcome measure(s)

• Efficacy of cleansing agent — 18 hours
  The primary endpoint is the efficacy of cleansing preparations measured by the quality of cleansing. This is done using the validated Harefield Cleansing Scale. The cleansing quality is measured after dividing the colon into 5 segments (Rectum, sigmoid colon, Descending colon, Transverse colon, and Ascending colon/Cecum) and each segment is scored from 0 (irremovable heavy hard stool), 1 (Semi-solid, only partially removable stools), 2 (Brown liquid/removable semi-solid stools) 3 (Clear liquid), and 4 (empty and clean), then a total grade is given. Grade A (all segments scored 3 or 4) and B (one or more segments scored 2) are considered as successful cleansing. Grade C (one or more segments scored 1) and D (one or more segments scored 0) is considered unsuccessful cleansing.

Trial sites (1)

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