Clinical trial phase IV, randomized, to evaluate the efficacy of Polyethylene glycol plus ascorbic acid vs Polyethylene glycol alone in patients with a history of poorly prepared colonoscopy .

Conditions: outpatients with past poor bowel preparation, defined as a score less than 5, according to the Boston scale
Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Registration Number: EUCTR2013-002506-31-ES

Lead Sponsor: Dr Antonio Gimeno

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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. (26)
? Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 438
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, prior inclusion.
The informed consent will be required for all subjects who met the inclusion criteria and none of the exclusion.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: 1) To compare the degree of tolerance between the two preparations.<br>2) To compare the detection rate of colorectal neoplasia;Primary end point(s): colonic cleansing assessed by a validated cleansing scale (Boston scale).;Timepoint(s) of evaluation of this end point: In colonoscopy examination, two days from starting treatment.;Main Objective: To compare a 4l PEG based intensive colonic cleansing with another one based on 2l PEG plus ascorbic acid in patients with past poor colon preparation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): to assess the tolerance by a visual analog scale and the detection of colorectal lesions.;Timepoint(s) of evaluation of this end point: In colonoscopy examination, two days from starting treatment.