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

NCT ID: NCT05192551

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-11-15

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

Detailed Description

When performing Colonoscopy it is essential to use a bowel-prep that is highly effective and at the same time tolerable to intake for the patient to ensure that the patients intakes the recommended amount of the bowel-prep.

This in order to be able to detect pathological findings in the mucosa. Currently in n Sweden the standard bowel-prep used in most endoscopy-units is high volume bowel preps (4 litres) in split dose. It can be difficult for the patient to intake the whole dose wish can lead to a sub-optimal bowel-cleansing.

Recently, in Sweden, a new low-volume bowel-prep has been approved and introduced (Plenvu).

This preparation, totally 1 litre of bowel prep given in a split dose is potentially easier for the patient to intake but it is essentially to ensure that the efficacy i at least as good as the current high dose preparation. In this study the investigators will therefore investigate patient satisfaction and efficacy of the different bowel preparations, comparing Plenvu with the current standard bowel-prep regime at the participating endoscopy units.

Five endoscopy units participates in this study (Endoskopi City, Stockholm, Endoskopienheten i Malmö, Endoskopienheten i Linköping, Endoskopienheten i Örebro, Endoskopienheten Ersta sjukhus, Stockholm).

In each endoscopy unit 100 consecutive patients will be prescribed Plenvu and another 100 consecutive patients will be prescribed the current standard bowel-prep at the actual unit. a total of 1000 patients will participate in the study.

The currently used bowel-preps at the different endoscopy units are: Vistaprep, Laxabon and Movprep This is a study performed in a clinical context and no randomization is made. When arriving to the endoscopy unit patients are asked to participate in the study and if willing to participate patients will sign an informed consent-form.

Before the colonoscopy the patients fills in a questionnaire about the bowel-prep experience concerning; smell, taste, overall experience (five graded scales) of the prep. In the questionnaire patients are also asked how much of the prescribed bowel-prep that have been digested and how much extra fluid the patient have been drinking during the preparation process. The patients are also asked about if they have been experienced nausea or been vomiting.

After the colonoscopy, the gastroenterologist performing the endoscopy fills in the Boston Bowel Preparation Scale (BBPS) as a measure of how successful the bowel cleansing has been.

Based on this information the investigators will compare patient satisfaction and efficacy of the bowel-cleansing in the group that has been prescribed Plenvu to the group that has been prescribed the endoscopy-units standard bowel-prep

Conditions

Patient Satisfaction and Efficacy of Bowel-preparation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Bowel-prep (Plenvu as experimental arm)

Intervention Type: 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

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.

Bowel-prep (Plenvu as experimental arm)

Intervention Type: 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

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.

Bowel-prep (Plenvu as experimental arm)

Intervention Type: 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

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.

Bowel-prep (Plenvu as experimental arm)

Intervention Type: 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

Interventions

Bowel-prep (Plenvu as experimental arm)

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

Intervention Type: OTHER

Other Intervention Names

Laxabon,; Vistaprep; Movprep

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Perjohan Lindfors

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitetssjukhuset Linköping

Linköping, , Sweden

Skåne Universitetssjukhus

Malmo, , Sweden

Universitetssjukhuset Örebro

Örebro, , Sweden

Aleris GastromottagningenCity

Stockholm, , Sweden

Ersta sjukhus

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

Bowelprep

Identifier Type: -

Identifier Source: org_study_id