NCT01887158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

11 months

First QC Date

June 11, 2013

Last Update Submit

June 15, 2014

Conditions

Intestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • quality of bowel preparation rated according to a modified Ottawa bowel preparation scale

    about 2 weeks after the randomization

Secondary Outcomes (3)

  • Tolerability to the preparation (specific questionaire)

    participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization

  • safety (adverse event rate)

    participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization

  • Lesion detection (type and lesion detection rate/patient)

    about 2 weeks from the randomization

Study Arms (2)

bisacodyl plus 2-Liter Polyethylene glycol

ACTIVE COMPARATOR

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.

Drug: Polyethylene glycolDrug: Bisacodyl

4-Liter Polyethylene glycol

ACTIVE COMPARATOR

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.

Drug: Polyethylene glycol

Interventions

Polyethylene glycolDRUG
4-Liter Polyethylene glycolbisacodyl plus 2-Liter Polyethylene glycol
BisacodylDRUG
bisacodyl plus 2-Liter Polyethylene glycol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inpatients
  • Emergency Colonoscopy
  • Comorbidities: Congestive heart failure, history of kidney disease, history of solid organ transplant
  • Pregnant and/or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alessandro Mussetto

Ravenna, RA, 48100, Italy

Location

Ospedale S.Maria delle Croci

Ravenna, RA, 48100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25910064DERIVED

MeSH Terms

Conditions

Intestinal Neoplasms

Interventions

Polyethylene GlycolsBisacodyl

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureCresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 11, 2013

First Posted

June 26, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

IT(2)