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

NCT04497935 | Completed

• 1 other identifier: PLNV012018
• Study Type: observational
• Target: 613
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Bowel preparation; Colonoscopy; Laxative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Degree of satisfaction with the two bowel preparation

  Patients were instructed to report any possible adverse events for up to 1 month after the procedure.

• 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.

Study Arms (2)

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.

Drug: PLENVU

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.

Drug: MoviPrep

Interventions

PLENVU DRUG

Bowel preparation for a colonoscopy

1LPEG

MoviPrep DRUG

Bowel preparation for a colonoscopy

2LPEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients aged \> 18 years and indicated for examination requiring bowel preparation

You may not qualify if:

• 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

Sponsors & Collaborators

• Unidade Local de Saúde do Alto Ave, EPE: lead

Study Sites (1)

Hospital Senhora da Oliveira

Guimarães, Portugal

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps

Interventions

Polyethylene Glycols; MoviPrep

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 4, 2020
• Study Start: January 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 4, 2020

Record last verified: 2020-07

Locations

PT (1)