Comparison of Two Preparations for the Study of the Colon Through Colonoscopy

July 31, 2020 updated by: Cátia Vanessa Meixedo Arieira, Hospital da Senhora da Oliveira

Comparative, Prospective and Randomized Study of Two Preparations for the Study of the Colon Through Colonoscopy

Compare the quality of bowel preparation between two groups of patients, who will undergo two different preparations: 1. Moviprep + diet; 2. Plenvu + diet

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The quality of bowel preparation is essential for the success of a colonoscopy, reducing colonoscopy duration, and increasing the rate of cecal intubation and of polyp detection. There are several types of preparations available on the market and, irrespective of the choice, the split-dose regimen should be followed. A reduced volume preparation makes the process easier and more tolerable, increasing adhesion. Regarding the diet to be applied before the examination, there are no advantages to a liquid diet compared to a low fiber diet, and there is no evidence on the duration of the diet. In addition, a restrictive diet has an impact on satisfaction and also on adherence to treatment.

Study Type

Observational

Enrollment (Actual)

613

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Guimarães, Portugal
        • Hospital Senhora da Oliveira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients aged > 18 years and indicated for a colonoscopy requiring bowel preparation in the Gastroenterology Service of the Hospital of Senhora da Oliveira - Guimarães.

Description

Inclusion Criteria:

  • All patients aged > 18 years and indicated for examination requiring bowel preparation

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Patients with gastroparesis or gastric obstruction.
  • Patients with psychiatric disorders
  • Severe renal impairment with CrCl <30mL/min
  • Class III-IV Heart Failure
  • Dependence / use of laxatives
  • Chronic constipation (<3 stools/week).
  • Uncontrolled hypertension (SBP >170mmHg or DBP >100mmHg)
  • Intestinal Obstruction
  • Colostomy from previous intestinal surgery
  • Severe ascites
  • Refusal of participation in the study
  • Patients unable to understand or respond to the satisfaction survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1LPEG
Patients receiving 1LPEG who had a colonoscopy in the morning were advised to follow a day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, they prepared the Dose 1 sachet in 500 mL of water and consumed it over a period of 30 minutes, followed by 500 mL of clear liquids. The second dose was then taken at 11:00 pm by mixing the two Dose 2 sachets in a single glass of 500 mL of water and consuming them over 30 minutes, followed by 500 mL of clear liquids. If the colonoscopy was scheduled for the afternoon, the same dosing instructions were given, but the first dose was taken at 7:00 am on the day of the procedure, and the second dose began at 10:00 am.
Drug: PLENVU
Bowel preparation for a colonoscopy
2LPEG
Patients receiving 2LPEG who had a colonoscopy in the morning were asked to follow a similar day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, the first 1L dose was consumed over a 1-hour period, followed by the second dose at 11:00 pm. For 2LPEG patients with procedures in the afternoon, they took Dose 1 at 7:00 am and Dose 2 at 10:00 am. Any patient receiving 2LPEG was also told to consume 1L of clear liquids during the preparation procedure.
Drug: MoviPrep
Bowel preparation for a colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of bowel preparation between the two groups of patients
Time Frame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of >6 with no individual segment scoring <2.
Patients were instructed to report any possible adverse events for up to 1 month after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of satisfaction with the two bowel preparation
Time Frame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
The level of patient satisfaction with the 2 bowel preparation regimens was also assessed through a comparative analysis of the patient satisfaction questionnaire
Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
Quality of bowel preparation in patients who had a morning or afternoon colonoscopy and those who received written, oral and additional telephone re-education on the day before the colonoscopy versus written and oral information only.
Time Frame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of >6 with no individual segment scoring <2.
Patients were instructed to report any possible adverse events for up to 1 month after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital da Senhora da Oliveira

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLNV012018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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