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

NCT ID: NCT04497935

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 613 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-07-01

Brief Summary

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

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.

Conditions

Colon Cancer; Colon Polyp; Colon Adenoma; Colon Rectal Cancer

Study Design

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

Study Groups

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.

PLENVU

Intervention Type: DRUG

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.

MoviPrep

Intervention Type: DRUG

Bowel preparation for a colonoscopy

Interventions

PLENVU

Bowel preparation for a colonoscopy

Intervention Type: DRUG

MoviPrep

Bowel preparation for a colonoscopy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unidade Local de Saúde do Alto Ave, EPE

OTHER

Sponsor Role: lead

Responsible Party

Cátia Vanessa Meixedo Arieira

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Senhora da Oliveira

Guimarães, , Portugal

Countries

Portugal

Other Identifiers

PLNV012018

Identifier Type: -

Identifier Source: org_study_id