Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study

NCT05192551 | Completed

• 1 other identifier: Bowelprep
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

Brief Summary

An multi-center, observational study where we compare the current standard, PEG-based bowel-prep to a (in Sweden) recently approved and introduced low volume (1 litre) PEG-based bowel-prep (Plenvu) in a clinical routine situation. The investigators will investigate if there are any differences in patient satisfaction and efficacy of the different bowel preparations

Conditions

Patient Satisfaction and Efficacy of Bowel-preparation

Keywords

Bowel-prep; Colonoscopy; Patient satisfaction

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction with bowel prep

  When arriving to the endoscopy unit the patients fills in a questionnaire about their bowel-prep experience concerning; smell, taste, overall experience (five graded scales) of the prep. The higher the number are the more satisfied the patient are with the current experience (smell, taste and overall experience. In the questionnaire they are also asked how much of the prescribed bowel-prep they have digested and how much extra fluid they have been drinking during the preparation process (0-4 litres).

  Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy

• Efficacy of the bowel prep

  Immediately after the colonoscopy the gastroenterologist who has performed the investigation fills in the Boston Bowel Preparation Scale,a widely used scale describing how clean the bowel is in each of the three segment ant in total. Each segment is graded form 0-3 (3 perfect cleaning) and a sum-score of 0-9 (9 perfect clening) is calculated. The higher the number the better the cleansing are

  Day 1,Directly after the colonoscopy,

Secondary Outcomes (1)

• Differences in the reported frequency of nausea and vomiting during the bowel-preparation process

  Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy

Study Arms (4)

Plenvu

A new type of low-volume bowel-prep recently approved and introduced in the Swedish market. The dose is 500 ml x 2, The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy.

Other: Bowel-prep (Plenvu as experimental arm)

Laxabon

A standard high volume bowel-prep, used for a long time in Sweden. The dose is 2000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy.

Other: Bowel-prep (Plenvu as experimental arm)

Vistaprep

A standard high volume bowel-prep, used for a long time in Sweden. The dose is 2000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy.

Other: Bowel-prep (Plenvu as experimental arm)

Movprep

A standard median volume bowel-prep, used for a long time in Sweden. The dose is 1000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy.

Other: Bowel-prep (Plenvu as experimental arm)

Interventions

Bowel-prep (Plenvu as experimental arm) OTHER

In this study we will investigate the efficacy and patient satisfaction of the,in Sweden recently approved and introduced low-dose, Peg-based bowel-prep Plenvu in comparsion with the standard bowel-preps used i today's clinical routine

Also known as: Laxabon,, Vistaprep, Movprep

Laxabon; Movprep; Plenvu; Vistaprep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that are scheduled for a routine colonoscopy at the endoscopy unit

You may qualify if:

• All patients over 18 admitted for colonoscopy at the participating endoscopy-units.

You may not qualify if:

• Renal failure or other contraindication for using low-dose bowel-preps
• not speking or reading swedish
• Need for a translator

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (5)

Universitetssjukhuset Linköping

Linköping, 58185, Sweden

Location

Skåne Universitetssjukhus

Malmo, 21428, Sweden

Location

Universitetssjukhuset Örebro

Örebro, 701 85, Sweden

Location

Aleris GastromottagningenCity

Stockholm, 11137, Sweden

Location

Ersta sjukhus

Stockholm, 11628, Sweden

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 14, 2022
• Study Start: April 1, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)