Changes of Serum Electrolytes During Bowel Prep With PEG 3350 + Ascorbic Acid - a Prospective Study

Hypothesis: Patients who undergo bowel preparation with PEG 3350 + ascorbic acid may have significant changes of serum electrolytes.

A new PEG solution (Moviprep = PEG 3350 + ascorbic acid) for colonoscopy reduces the amount of cathartic solution to 2 liters, but requires drinking of additional liquid for optimal results. Ingestion of a high volume of free water bears a risk for severe changes of serum electrolytes, particularly for sodium and potassium.

In this trial, patients undergo regular bowel preparation for standard colonoscopy with Moviprep (2 liters Moviprep split-dose plus ≥2 liters of free liquid until sufficient cleansing is achieved). Blood samples for serum sodium, potassium, chloride, magnesium, phosphate, calcium and serum osmolarity are taken before the beginning of the prep procedure and right before colonoscopy. The interval between both blood samples that will be compared is roughly 24 hours. Additionally, the volume of prep solution and additional liquid is recorded. The quality of bowel preparation is visually rated during colonoscopy with a validated score.

Pre- and postpreparation serum parameters will be compared. Primary outcome measure is the proportion of patients who have a serum sodium beyond the reference values after the completion of bowel preparation. Secondary outcome parameters are the proportion of patients with other serum electrolytes or serum osmolarity beyond the reference. Moreover, changes of serum electrolytes and osmolarity will be correlated with the amount of prep solution and liquid.

Study Overview

• Status: Completed
• Conditions: Colonoscopy

• Study Type: Observational
• Enrollment (Actual): 190

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81925
    • Klinikum Bogenhausen - Klinikum München GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an indicaton for colonoscopy

Description

Inclusion Criteria:

• indication for colonoscopy
• >=18 years

Exclusion Criteria:

• <18 years
• acute inflammatory bowel disease
• previous bowel resection
• high-grade cardiac or renal insufficiency

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with serum sodium concentration beyond the limits of normal after the completion of bowel preparation	within 2 hours before the beginning of colonoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with serum potassium or calcium or chloride or magnesium concentration beyond the limits of normal after the completion of bowel preparation	within 2 hours before the beginning of colonoscopy

Collaborators and Investigators

• Sponsor: Klinik Bogenhausen

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 15, 2016

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation; water; electrolytes; osmolality
• Other Study ID Numbers: GastroKMBColEl