Clinical trial NCT01909219: PMC Split Preparation for Colon Cleansing
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colon Cleansing
Keywords: preparation, cleansing, colon
Lead sponsor: Luigi Sacco University Hospital
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 862
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* adult outpatients
* aged 18-85 yr
* undergoing elective colonoscopy

Exclusion Criteria:

* previous colon resection,
* ileus,
* 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),
* ascites,
* phenylketonuria,
* glucose-6-phosphate dehydrogenase deficiency,
* pregnant or breastfeeding women

Primary outcomes:
measure: Rate of adequate colon cleansing
timeFrame: 24 hrs
Secondary outcomes:
measure: Patients' acceptance, tolerability and compliance to the cleansing regimen
timeFrame: 24 hrs
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Luigi Sacco University Hospital
Study officials:
affiliation: Sacco Huniversity Hospital
name: Gianpiero Manes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manes G, Repici A, Hassan C; MAGIC-P study group. Randomized controlled trial comparing efficacy and acceptability of split- and standard-dose sodium picosulfate plus magnesium citrate for bowel cleansing prior to colonoscopy. Endoscopy. 2014 Aug;46(8):662-9. doi: 10.1055/s-0034-1365800. Epub 2014 Jul 14.