A Randomized Controlled Trial Comparing Efficacy and Acceptability of Split and Standard Dose Sodium Picosulphate/Magnesium Citrate for Bowel Cleansing Prior to Colonoscopy: the MAGIC-P Multicenter Study
Overview
- Phase
- Phase 4
- Intervention
- Sodium picosulphate/magnesium Citrate
- Conditions
- Colon Cleansing
- Sponsor
- Luigi Sacco University Hospital
- Enrollment
- 862
- Locations
- 1
- Primary Endpoint
- Rate of adequate colon cleansing
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated to higher efficacy and acceptability in comparison to the standard dose regimen in bowel cleansing before colonoscopy
Detailed Description
Picosulphate/magnesium citrate is a very effective, safe and tolerated low-volume preparation for colon cleansing. This study evaluates whether split dosing is associated to a further increase in efficacy and acceptability in comparison to the standard dose regimen. This is a multicenter, randomized, single-blind study performed in 15 endoscopic services in Italy. Adult outpatients undergoing colonoscopy will receive picosulphate/magnesium citrate either in the standard dosing (group A, two sachets the day before endoscopy), or in the split dosing (group B, the second dose in the morning of colonoscopy). Bowel cleansing will be assessed using the Boston Scale (BBPS) and rated as adequate if \>2 in each segment. Patient acceptance, satisfaction, and related symptoms will be also recorded.
Investigators
Gianpiero Manes
Medical Doctor
Luigi Sacco University Hospital
Eligibility Criteria
Inclusion Criteria
- •adult outpatients
- •aged 18-85 yr
- •undergoing elective colonoscopy
Exclusion Criteria
- •previous colon resection,
- •intestinal obstruction,
- •toxic megacolon,
- •severe heart failure (NYHA Class III or IV),
- •acute cardiovascular disease,
- •uncontrolled arterial hypertension (systolic pressure \>170 mmHg, diastolic pressure \>100 mmHg),
- •severe liver cirrhosis (Child-Pugh score C),
- •renal failure (creatinine clearance\<30 mL/minute),
- •phenylketonuria,
- •glucose-6-phosphate dehydrogenase deficiency,
Arms & Interventions
Group A: standard regimen
Patients in the group A (standard regimen) will be instructed to take the two sachets of sodium picosulphate/magnesium citrate diluted in a glass of water 2-4 hours apart, starting at 5 pm the day before colonoscopy.
Intervention: Sodium picosulphate/magnesium Citrate
Group B
Patients in the group B (split regimen) will be instructed to take the first sachet of sodium picosulphate/magnesium citrate at 7 pm the day before colonoscopy and the second one at 6 am in the morning on the day of colonoscopy.
Intervention: Sodium picosulphate/magnesium Citrate
Outcomes
Primary Outcomes
Rate of adequate colon cleansing
Time Frame: 24 hrs
The primary endpoint of the study was the quality of overall colon cleansing, assessed by the endoscopist. Colon cleansing quality was dichotomized as "adequate" (score \> 2 in each colon segment) or "inadequate" (score \< 2 in one or more colon segments
Secondary Outcomes
- Patients' acceptance, tolerability and compliance to the cleansing regimen(24 hrs)