Clinical trial NCT05192551: Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study
Official title: Comparison of Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study in Five Endoscopy Units in Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Satisfaction and Efficacy of Bowel-preparation
Keywords: Bowel-prep
Colonoscopy
Patient satisfaction
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are scheduled for a routine colonoscopy at the endoscopy unit

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

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

Primary outcomes:
measure: Patient satisfaction with bowel prep
timeFrame: Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy
measure: Efficacy of the bowel prep
timeFrame: Day 1,Directly after the colonoscopy,
Secondary outcomes:
measure: Differences in the reported frequency of nausea and vomiting during the bowel-preparation process
timeFrame: Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Universitetssjukhuset Linköping
city: Malmö
country: Sweden
facility: Skåne Universitetssjukhus
city: Stockholm
country: Sweden
facility: Aleris GastromottagningenCity
city: Stockholm
country: Sweden
facility: Ersta sjukhus
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
Study officials:
References: