Impact of Time Intervals of Preparation on Quality and Tolerance of the Bowel Preparation

Faculty Hospital Kralovske Vinohrady

Status and phase: Unknown; Phase 4

Conditions: Colonoscopy; Bowel Preparation

Treatments: Procedure: Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02908919

CB1601

Details and patient eligibility

About

The purpose of this study is to determine optimal time intervals for preparation before colonoscopy using different formulas.

Full description

Different formulas are used for bowel preparation before colonoscopy. Present guidelines are based on conventional polyethylene glycol. Their validity for other preparations were not evaluated. Relationship between length of preparation, interval to colonoscopy and bowel preparation quality, tolerance are assessed.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects referred to diagnostic or therapeutic colonoscopy.

Exclusion criteria

• ileus
• known or suspected bowel obstruction
• active bowel inflammation
• pregnancy
• any presence of serious medical conditions ( esp. cardiac, renal, liver diseases)
• history of prior colonic or rectal surgery
• inability to obtain valid data from

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

480 participants in 3 patient groups

Fortrans pulv. sol

Active Comparator group

Description:

Polyethylene glycol solution. Used 4 l before colonoscopy. Bowel preparation interval: QD/BID or one day.

Treatment:

Procedure: Colonoscopy

Picoprep pulv. sol.

Active Comparator group

Description:

Natrium picosulfate/ magnesium citrate solution. Used 2 l before colonoscopy. bowel preparation interval: QD/BID or one day.

Treatment:

Procedure: Colonoscopy

Moviprep pulv. sol.

Active Comparator group

Description:

Polyethylene glycol + ascorbic acid solution. Used 2 l before colonoscopy. Bowel preparation interval: QD/BID or one day.

Treatment:

Procedure: Colonoscopy