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

Sponsor
Fundación Canaria Rafael Clavijo para la Investigación Biomédica (Other)
Overall Status
Completed
CT.gov ID
NCT02073552
Collaborator
(none)
472
Enrollment
1
Location
2
Arms
24
Duration (Months)
19.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Polyethylene glycol 4000
  • Drug: Macrogol 3350 plus ascorbic acid
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
472 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Diagnostic
Official Title:
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
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Colon cleansing [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.

Secondary Outcome Measures

  1. Tolerance of bowel preparation [Tolerance will be assessed just before colonoscopy by a research assistant]

    It will be assessed by using a visual analog scale colon

  2. Detection of colorectal neoplasia [14 months]

    Detection rate of adenoma and colorectal cancer will be assessed for both groups (low volume and high volume preparation)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario de Canarias Santa Cruz de Tenerife Spain 38320

Sponsors and Collaborators

  • Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alberto Domínguez Rodríguez, MD,PhD, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier:
NCT02073552
Other Study ID Numbers:
  • REPREP1
  • 2013-002506-31
First Posted:
Feb 27, 2014
Last Update Posted:
Jun 27, 2016
Last Verified:
Sep 1, 2015
Keywords provided by Alberto Domínguez Rodríguez, MD,PhD, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
colon cleansing, bowel preparations; polyethyleneglycol
Additional relevant MeSH terms:
Ascorbic Acid
Polyethylene glycol 3350

Study Results

No Results Posted as of Jun 27, 2016