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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04497935
Enrollment
613
Registered
2020-08-04
Start date
2019-01-01
Completion date
2019-07-01
Last updated
2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Colon Polyp, Colon Adenoma, Colon Rectal Cancer

Keywords

Bowel preparation, Colonoscopy, Laxative

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.

Interventions

DRUGPLENVU

Bowel preparation for a colonoscopy

Bowel preparation for a colonoscopy

Sponsors

Unidade Local de Saúde do Alto Ave, EPE
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of bowel preparation between the two groups of patientsPatients 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

MeasureTime frameDescription
Degree of satisfaction with the two bowel preparationPatients 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
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.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.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026