Clinical trial NCT01887158: Efficacy of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection
Official title: Phase 4 Study of Comparison of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection. A Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intestinal Cancer
Lead sponsor: Ospedale Santa Maria delle Croci
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studies that have investigated different bowel preparations in patients with history of colorectal surgery are surprisingly lacking.Therefore, which is the best colon preparation in this subgroup of patients is still unknown. Polyethylene glycol (PEG)-based solutions are the most popular and safest bowel preparation regimens, however the 4-Liter volume is often poorly tolerated. More recently, it has been shown that the use of a low volume preparation (2-Liter PEG solution with the adjunct of a laxative, bisacodyl) achieves comparable bowel cleanliness rates to 4-Liter PEG in general population.The primary aim will be to compare the efficacy of 2-L mixed preparation (bisacodyl plus PEG) to 4-L PEG preparation.


Eligibility criteria: Inclusion Criteria:

1. Outpatients
2. ≥18 yrs old,
3. Prior history of colorectal resection due to colo-rectal cancer, referred for surveillance colonoscopy

Exclusion Criteria:

1. Inpatients
2. Emergency Colonoscopy
3. Comorbidities: Congestive heart failure, history of kidney disease, history of solid organ transplant
4. Pregnant and/or lactating women

Primary outcomes:
measure: quality of bowel preparation rated according to a modified Ottawa bowel preparation scale
timeFrame: about 2 weeks after the randomization
Secondary outcomes:
measure: Tolerability to the preparation (specific questionaire)
timeFrame: participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization
measure: safety (adverse event rate)
timeFrame: participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization
measure: Lesion detection (type and lesion detection rate/patient)
timeFrame: about 2 weeks from the randomization
Other outcomes:
Locations:
city: Ravenna
country: Italy
facility: Alessandro Mussetto
state: RA
city: Ravenna
country: Italy
facility: Ospedale S.Maria delle Croci
state: RA
Study officials:
References:
citation: Mussetto A, Frazzoni L, Paggi S, Dari S, Laterza L, Radaelli F, Hassan C, Triossi O, Fuccio L. Split dosing with a low-volume preparation is not inferior to split dosing with a high-volume preparation for bowel cleansing in patients with a history of colorectal resection: a randomized trial. Endoscopy. 2015 Oct;47(10):917-24. doi: 10.1055/s-0034-1391987. Epub 2015 Apr 24.