A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate

Colorectal Cancer Clinical Trial

Official title:

A Randomized Prospective Trial Comparing Different Regimens of Polyethylene Glycol-based Lavage and Sodium Picosulphate With Magnesium Citrate in the Preparation of Patients for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778192
• Other study ID #: Korea University
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2013
• Last updated: January 29, 2013
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Adequate bowel cleansing is important for a completeness of colonoscopy and detection of colon polyps. Inadequate bowel preparation leads to longer duration of colonoscopy and obscured mucosal visualization resulting in missed lesions.

Bowel cleansing agents are simply classified into the large volume, iso-osmotic polyethylene glycol (PEG) based solutions or the small volume osmotically active agents, such as sodium picosulphate with magnesium citrate (SPMC).

There are rare reports that compare directly conventional polyethylene glycol (PEG) solution and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea.

The aim of this study is to compare the efficacy, safety, and tolerability of different regimens of SPMC and PEG solution.

Description:

1. Study design: endoscopist-blinded, prospective, randomized controlled trial

2. Subjects

1. Entry criteria: Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study.

2. Exclusion criteria:

gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled inflammatory bowel disease, previous colorectal resection, congestive heart failure, recent acute myocardial infarction or unstable angina, uncontrolled arterial hypertension, renal insufficiency with glomerular filtration rate < 60 ml/minute/1.73 m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity to any bowel cleansing agents.

3. Sampling design: Consecutive recruitment of consenting patients

4. Variables Predictor

1. group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy

2. group 2 (split PEG) received 2 L of PEG at 6:00 p.m the evening before colonoscopy and 2 L of PEG at 4-6 hours before procedure

3. group 3 (SPMC 2) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure;

4. group 4 (SPMC 3) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m the evening before colonoscopy and another sachet at 4-6 hours before procedure.

5. Primary Outcome: Quality of bowel preparation (Ottawa scale)

6. Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study

Exclusion Criteria:

• gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled inflammatory bowel disease, previous colorectal resection, congestive heart failure, recent acute myocardial infarction or unstable angina, uncontrolled arterial hypertension, renal insufficiency with glomerular filtration rate < 60 ml/minute/1.73 m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity to any bowel cleansing agents.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colon Adenoma
• Colorectal Cancer

Intervention

Drug:
• Polyethylene glycol
-group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
• Polyethylene glycol
-group 2 (split PEG, N=50) received 2 L of PEG at 6:00 p.m the evening before colonoscopy and 2 L of PEG at 4-6 hours before procedure
• Sodium picosulphate with magnesium citrate
-group 3 (SPMC 2) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure
• Sodium picosulphate with magnesium citrate
-group 4 (SPMC 3) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m the evening before colonoscopy and another sachet at 4-6 hours before procedure.

Locations

Country	Name	City	State
Korea, Republic of	Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS)	Immediately following the colonoscopy, the endoscopist who were unaware of the preparation regimen scored the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS).	20 minutes	No
Secondary	Completeness of the bowel preparation	Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.	30 minutes before the colonoscopy	No
Secondary	the patient's tolerability	Patients were asked with questionnaires about the symptoms associated with the preparation to assess the patients' tolerability before the colonoscopy. Patients were asked whether they experienced any of the following : abdominal fullness, cramping, nausea, vomiting, sleep disturbance, and overall discomfort, and these symptoms were scored on a 5-point scale where 1 = "none", 2 = "mild", 3 = "moderate", 4 = "severe", and 5 = "very severe".	30 minutes before the colonoscopy	Yes
Secondary	the side effects of the sodium picosulphate and magnesium citrate	Biochemical measures detected outrange of serum electrolytes (sodium, potassium, chloride, calcium, magnesium, and phosphate), blood urea nitrogen, creatinine and serum osmolality only for the sodium picosulphate and magnesium citrate.; Biochemical measurement was done done for the patients in the polyethylene glycol groups due to the well established safety date of the polyethylene glycol solutions.	1 hour before the colonoscopy	Yes