NCT01554111

Brief Summary

Objective and Hypothesis: The investigators objective is to help determine the efficacy of oral and rectal bowel preparation regimens for sigmoidoscopy. The investigators hypothesis is that oral preparation will reduce the amount of repeat rectal enemas required and improve the quality of a bowel exam at the sigmoidoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2012

Longer than P75 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

March 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

3.5 years

First QC Date

March 1, 2012

Last Update Submit

September 23, 2015

Conditions

Cathartic Colon

Keywords

Bowel EvacuantsPurgatives

Outcome Measures

Primary Outcomes (1)

  • Quality of colon cleansing

    The primary outcomes for this trial will be the quality of colon cleansing in the area of the colon examined. We will use a modified Ottawa bowel preparation scoring system measured at the time of endoscopy

    At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy

Secondary Outcomes (4)

  • Patient tolerance questionnaire

    At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy

  • Requirement for an additional rectal enema.

    At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy

  • Maximum length of scope inserted

    At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy

  • Reason for discontinuing further advancement of the scope

    At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy

Study Arms (3)

Picosalax with rectal enema

ACTIVE COMPARATOR

This arm will receive one satchet of Picosalx and a rectal enema before the sigmoidoscopy for their bowel preparation regimen.

Drug: Pico-Salax and Sodium phosphate enema

rectal enema

ACTIVE COMPARATOR

This group of patients will receive only a rectal enema for bowel preparation before their flexible sigmoidoscopy.

Drug: phosphosoda rectal enema

Pico-Salax

ACTIVE COMPARATOR

patient will take one sachet of pico-salax

Drug: Picosulfate sodium,

Interventions

Picosulfate sodium,DRUG

One sachet of picosalax will be given with at least 4 cups of clear fluids.

Also known as: PicoSalax
Pico-Salax
phosphosoda rectal enemaDRUG

The patient will have an enema inserted into the rectum and the liquid contents of the enema will be squeezed into the rectum. The patient will need to hold in the enema for several minutes then can release it.

rectal enema
Pico-Salax and Sodium phosphate enemaDRUG

Pt will take one sachet of Pico-salax the evening prior to procedure and fleet enema 1 hour before leaving home on the morning of the procedure

Also known as: Sodium picosulfate
Picosalax with rectal enema

Eligibility Criteria

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

You may not qualify if:

  • previous colorectal surgery and patients with reduced renal function or other medical conditions that would increase the risk of receiving oral PicoSalx would be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Interventions

picosulfate sodiumPico-Salax

Study Officials

  • Lawrence Hookey, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

  • Samson K. Haimanot, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Queen's University, Department of Medicine

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 14, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

CA(2)