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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497935
• Other study ID #: PLNV012018
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2020
• Source: Hospital da Senhora da Oliveira
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colon Cancer
• Colon Polyp
• Colon Rectal Cancer

Intervention

Drug:
• PLENVU
Bowel preparation for a colonoscopy
• MoviPrep
Bowel preparation for a colonoscopy

Locations

Country	Name	City	State
Portugal	Hospital Senhora da Oliveira	Guimarães

Sponsors (1)

Lead Sponsor	Collaborator
Hospital da Senhora da Oliveira

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of bowel preparation between the two groups of patients	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	Degree of satisfaction with the two bowel preparation	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.
Secondary	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.	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.