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NCT Number: NCT04497935

Comparison 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

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Key information

Conditions

Colon Cancer Colon Adenoma Colon Polyp Colon Rectal Cancer Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Senhora da Oliveira

Guimarães, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plenvu

Drug

Bowel preparation for a colonoscopy

MoviPrep

Drug

Bowel preparation for a colonoscopy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Unidade Local de Saúde do Alto Ave, EPE

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 4, 2020
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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