NCT01624454

Brief Summary

Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 9, 2013

Status Verified

June 1, 2012

Enrollment Period

8 months

First QC Date

June 18, 2012

Last Update Submit

May 7, 2013

Conditions

Bowel Cleansing for Colonoscopy

Keywords

colonoscopybowel cleansing

Outcome Measures

Primary Outcomes (1)

  • Bowel cleansing quality

    1 Day

Secondary Outcomes (1)

  • Colonoscopy findings

    1 Day

Study Arms (2)

large volume

ACTIVE COMPARATOR

bowel cleansing with PEG

Other: Laxabon

Osmotic

ACTIVE COMPARATOR
Other: CitraFleet

Interventions

LaxabonOTHER

4 l PEG solution split dose cleansing

large volume
CitraFleetOTHER

Small volume osmotic bowelcleansing

Osmotic

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pts for out-patient colonoscopy
  • age 18-80

You may not qualify if:

  • Active colitis or suspicion thereof (bloody diarrhea, fever and abdominal pain)
  • Suspicion of renal insufficiency or ileus/subileus
  • Previous colonic surgery
  • Pregnancy
  • Inability to adhere to cleansing instructions
  • Inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OUS Rikshospitalet, dept of med gastro

Oslo, Oslo County, Norway

Location

Sørlandet sykehus

Kristiansand, VestAgder, Norway

Location

Related Publications (1)

  • Leitao K, Grimstad T, Bretthauer M, Holme O, Paulsen V, Karlsen L, Isaksen K, Cvancarova M, Aabakken L. Polyethylene glycol vs sodium picosulfate/magnesium citrate for colonoscopy preparation. Endosc Int Open. 2014 Dec;2(4):E230-4. doi: 10.1055/s-0034-1377520. Epub 2014 Oct 24.

    PMID: 26135098DERIVED

Study Officials

  • Lars Aabakken, prof of med

    Prof of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 9, 2013

Record last verified: 2012-06

Locations

NO(2)