Clinical trial NCT04497935: Comparison of Two Preparations for the Study of the Colon Through Colonoscopy
Official title: Comparative, Prospective and Randomized Study of Two Preparations for the Study of the Colon Through Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Colon Polyp
Colon Adenoma
Colon Rectal Cancer
Keywords: Bowel preparation
Colonoscopy
Laxative
Lead sponsor: Hospital da Senhora da Oliveira
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Quality of bowel preparation between the two groups of patients
timeFrame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
Secondary outcomes:
measure: Degree of satisfaction with the two bowel preparation
timeFrame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
measure: 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.
timeFrame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
Other outcomes:
Locations:
city: Guimarães
country: Portugal
facility: Hospital Senhora da Oliveira
Study officials:
References: