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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Woo-Jin Lee, Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT01778192
First received: January 25, 2013
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Colon Adenoma
Drug: Polyethylene glycol
Drug: Sodium picosulphate with magnesium citrate
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS) [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Completeness of the bowel preparation [ Time Frame: 30 minutes before the colonoscopy ] [ Designated as safety issue: No ]
    Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.

  • the patient's tolerability [ Time Frame: 30 minutes before the colonoscopy ] [ Designated as safety issue: Yes ]
    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".

  • the side effects of the sodium picosulphate and magnesium citrate [ Time Frame: 1 hour before the colonoscopy ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 200
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Same day PEG
group 1 (same day PEG, N=50) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
Drug: Polyethylene glycol
-group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
Other Name: Colyte(Taejoon Pharmaceuticals, Seoul, Korea)
Active Comparator: split PEG
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
Drug: 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
Other Name: Colyte(Taejoon Pharmaceuticals, Seoul, Korea)
Active Comparator: SPMC 2
group 3 (SPMC 2, N=50) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure
Drug: 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
Other Name: Picolight(Pharmbio korea, Seoul, Korea)
Active Comparator: SPMC 3
group 4 (SPMC 3, N=50) 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.
Drug: 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.
Other Name: Picolight(Pharmbio korea, Seoul, Korea)

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01778192

Locations
Korea, Republic of
Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine
Seoul, Korea, Republic of, ASI/KR/KS013/SEOUL
Sponsors and Collaborators
Korea University Anam Hospital
Investigators
Study Director: Yoon Tae Jeen Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
Principal Investigator: Eun Sun Kim Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
Principal Investigator: Woo Jin Lee Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
  More Information

No publications provided

Responsible Party: Woo-Jin Lee, fellow, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT01778192     History of Changes
Other Study ID Numbers: Korea University
Study First Received: January 25, 2013
Last Updated: January 29, 2013
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Korea University Anam Hospital:
Bowel preparation
Polyethylene glycol
Sodium picosulphate

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Citric Acid
Picosulfate sodium
Magnesium citrate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 26, 2014