ClinicalTrials.Veeva

Menu

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)

O

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

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: Bisacodyl
Drug: Polyethylene glycol
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

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems