Colon Cleansing Quality of Polyethylene Glycol Compared With Polyethylene Glycol Plus Ascorbic Acid. (REPREP1)

June 24, 2016 updated by: Alberto Domínguez Rodríguez, Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Randomized Clinical Trial to Evaluate the Colon Cleansing Quality of Polyethylene Glycol Compared With Polyethylene Glycol Plus Ascorbic Acid in Patients With Past Poor Colonic Preparation

The purpose of the study is to assess whether a low volume polyethylene glycol (PEG) plus ascorbic acid based bowel preparation for colonoscopy is not inferior to a large volume polyethylene glycol preparation in subjects with past history of poor bowel preparation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two key quality indicators for colonoscopy are the cecal intubation rate and the percentage of neoplastic lesions detected. Both factors are associated with adequate bowel cleansing. Poor cleansing ranged from 5% to 30% across studies, negatively affecting the efficiency of colonoscopy.

The most important factor associated with poor colonic preparation is the past history of poor bowel preparation. However, there are no recommendations on the proper type of preparation in those patients. In two non-randomized studies inadequate cleansing in the second colonoscopy ranged from 9.8% to 23%. Randomized studies comparing high volume (3-4 liters) with low volume (2 liters) PEG preparations, which are better tolerated by patients, are therefore needed before making any recommendations in this regard.

Study Type

Interventional

Enrollment (Actual)

472

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Santa Cruz de Tenerife, Spain, 38320
        • Hospital Universitario de Canarias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age> 18 years
  • Outpatients with a history of past poor bowel prep, defined according to the Boston scale as a score less than 5.
  • Signed informed consent

Exclusion Criteria:

paralytic ileus, intestinal obstruction, megacolon, poorly controlled hypertension (systolic pressure> 180, dyastolic pressure> 100), congestive heart failure, acute liver failure, end stage renal disease (dialysis or pre-dialysis), New York Heart Association class III-IV, pregnancy, diagnosis of phenylketonuria, diagnosis of glucose-6-phosphate dehydrogenase deficiency, dementia. History of poor preparation in the previous colonoscopy, colon resection, less than 75% intake of the bowel preparation in the index colonoscopy, refusal to participate in the study, patients in whom a new colonoscopy is not indicated despite a poor bowel preparation(i.e. ileal Crohn disease with poor large bowel preparation), lack of compliance with the bowel preparation schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High volume
  • Two 5 mg bisacodyl tablets It is a stimulant laxative with local action.
  • Polyethylene glycol 4000: 16 envelopes (70 g of powder each). It includes electrolytes and sodium sulfate.
Drug: Polyethylene glycol 4000
- Polyethylene glycol 4000: 16 envelopes (70 g of powder each). It includes electrolytes and sodium sulfate. These substances make PEG metabolically inert, achieving a suitable osmotic balance, despite having a high molecular weight. The preparation passes along the gastrointestinal tract without causing net absorption of fluid or electrolytes. It is routinely used in clinical practice for bowel cleansing, before abdominal surgery, barium enema and other colorectal and genitourinary tract tests. Participants will divide the whole doses in 4 liters of water taking half the day before the examination starting at 20.00 h and the other half at 6.00 pm on the day of the examination.
Experimental: Low volume
  • Two 5 mg bisacodyl tablets, taken in the same way as for the high volume group.
  • Macrogol 3350 plus ascorbic acid: 4 envelopes, 2 containing 112 g polyethylene glycol and electrolytes and 2 with 2 g of ascorbic acid.
Drug: Macrogol 3350 plus ascorbic acid
- Macrogol 3350 plus ascorbic acid: 4 envelopes, 2 containing 112 g polyethylene glycol and electrolytes and 2 with 2 g of ascorbic acid. The properties of the polyethylene glycol are the same as those mentioned previously, while ascorbic acid generates an osmotic gradient potentiating the effect of polyethylene glycol. It is used routinely as a bowel prep. Participants will divide the doses in 2 liters of water taking half the day before (112 g of PEG and an 11 g of ascorbic acid) the examination at 20.00 h and the other half at 6.00 pm on the day of the examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colon cleansing
Time Frame: 30 days
Colon cleansing will be assessed just after colonoscopy by the endoscopist in charge of performing the examination and afterwards images were reviewed by a the staff of endoscopists for validation (30 days). For assessing colon cleansing a validated scale (Boston scale) will be used.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance of bowel preparation
Time Frame: Tolerance will be assessed just before colonoscopy by a research assistant
It will be assessed by using a visual analog scale colon
Tolerance will be assessed just before colonoscopy by a research assistant
Detection of colorectal neoplasia
Time Frame: 14 months
Detection rate of adenoma and colorectal cancer will be assessed for both groups (low volume and high volume preparation)
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Investigators

  • Principal Investigator: Antonio Z Gimeno García, MD, PhD, Hospital Universitario de Canarias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REPREP1
  • 2013-002506-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonoscopy Preparation

Clinical Trials on Polyethylene glycol 4000

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe