Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01093274
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

Patients intended for ambulatory colonoscopy will be randomized into 2 groups

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation	Drug: Sodium Picosulphate; Drug: Polyethylene Glycol	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Diagnostic
• Official Title: Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy, a Prospective Randomized, Controlled Study

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Polyethylene glycol Preparation with Polyethylene Glycol and bisacodyl	Drug: Polyethylene Glycol; 3 Liters solution; Other Names: Meroken new Go-Lytely
Experimental: Picolax Preparation with Sodium Picosulphate and Bisacodyl.	Drug: Sodium Picosulphate; 2 Sachets

Outcome Measures

Primary Outcome Measures

1. Percentage of patients requiring repeat colonoscopy because of poor preparation [quality of preparation will be assessed during colonoscopy]

   Quality of preparation: good, moderate, poor

Secondary Outcome Measures

1. Patient's satisfaction as measured by questionnaire and willingness to repeat same preparation on future examination [Questionnaire will be filled before colonoscopy]

   Patient satisfaction on questionnaire referring to taste, compliance with protocol, side effects, willingness to repeat preparation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ambulatory patients scheduled for elective colonoscopy

• Age 18-80

Exclusion Criteria:

• Renal insufficiency (serum creatinine ≥2.0 mg/dl)

• Symptomatic congestive heart failure

• Recent myocardial infarction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center - Beilinson Hospital	Petach Tikva		Israel	4910

Sponsors and Collaborators

• Rabin Medical Center

Investigators

• Principal Investigator: Eyal Gal, MD, Rabin Medical Center - Beilinson hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01093274
• Other Study ID Numbers: Gal001
• First Posted: Mar 25, 2010
• Last Update Posted: Mar 25, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: colonoscopy; Cathartics; Sodium picosulfate; Polyethylene Glycol
• Additional relevant MeSH terms: Picosulfate sodium

Study Results

No Results Posted as of Mar 25, 2010