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 (PEGOP)

Ospedale Santa Maria delle Croci

Status and phase: Completed; Phase 4

Conditions: Intestinal Cancer

Treatments: Drug: Polyethylene glycol; Drug: Bisacodyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01887158

PEGOP0613

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

bisacodyl plus 2-Liter Polyethylene glycol

Active Comparator group

Description:

Patients randomized to the low-volume arm, will be invited to consume 2 sachets of Lovol-esse (Polyethylene glycol) in one liter of water at 8:00 PM the evening before the colonoscopy and 2 sachets in one liter of water 4 hours before their scheduled colonoscopy appointment; furthermore, the patients will be instructed to take three 5-mg tablets of bisacodyl the day before the procedure, at 5:00 PM.

Treatment:

Drug: Polyethylene glycol

Drug: Bisacodyl

4-Liter Polyethylene glycol

Active Comparator group

Description:

Patients assigned to the high-volume arm will be invited to consume 2 envelopes of Selg-esse 1000 (polyethylene glycol) in 2 litres of water and drink the resulting solution in about 2-3 hours starting at 6:00 PM the evening before the colonoscopy; the day of the procedure, starting 5 hours before the procedure, the patients will be invited to complete the preparation with 2 others envelopes of Selg-esse 1000 (polyethylene glycol) dissolved in 2 litres of water.

Treatment:

Drug: Polyethylene glycol